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TLK286 (Telcyta) in Combination With Carboplatin (Paraplatin) Versus Doxil in Platinum Refractory or Resistant Ovarian Cancer

NCT00102973CompletedPHASE3INTERVENTIONAL

Summary

The purpose of this research study is to determine if TLK286 given in combination with carboplatin is more effective than liposomal doxorubicin in treating women who have recurrent ovarian epithelial cancer, fallopian tube cancer, or primary peritoneal cancer, that is refractory or resistant to platinum chemotherapy.

Key Facts

Lead Sponsor

Telik

Enrollment

244

Start Date

2004-12-01

Completion Date

2008-07-01

Study Type

INTERVENTIONAL

Official Title

Phase III Randomized Study of TLK286 (Telcyta) in Combination With Carboplatin (Paraplatin) Versus Liposomal Doxorubicin (Doxil) as Second-Line Therapy in Platinum Refractory or Resistant Ovarian Cancer [ASSIST-3]

Interventions

TLK286 in Combination with CarboplatinDoxorubicin HCl Liposome Injection

Conditions

Ovarian Neoplasms

Eligibility

Age Range

18 Years+

Sex

FEMALE

Inclusion Criteria:

* Are a woman 18 years of age or older
* Have histologically or cytologically confirmed epithelial cancer of the ovary or fallopian tube, or primary peritoneal cancer
* Have platinum refractory or resistant cancer
* Measurable disease according to radiographic RECIST criteria with documented tumor progression

Exclusion Criteria:

* Had treatment with first-line chemotherapy other than platinum-based regimens (carboplatin or cisplatin)
* Have clinically significant cardiac disease
* Have any sign of intestinal obstruction interfering with nutrition at the time of study entry
* Are pregnant or lactating
* Had prior treatment with liposomal doxorubicin for ovarian cancer
* Had prior treatment with TLK286

Outcome Measures

Primary Outcomes

Study Objectives

To demonstrate superiority in the objective response rate (ORR) of TLK286 in combination with carboplatin as compared to active control therapy with liposomal doxorubicin

Time frame: Every 8 Weeks

Locations

Little Rock Hematology Oncology, Little Rock, United States

Arkansas Oncology Associates, Little Rock, United States

Little Rock Hematology Oncology, Little Rock, United States

University of Arkansas for Medical Sciences, Little Rock, United States

Arkansas Oncology Associates, Little Rock, United States

Southern California Permanente Medical Group, Anaheim, United States

East Bay Oncology/Hematology Medical Associates, Inc., Antioch, United States

Southern California Permanente Medical Group, Baldwin Park, United States

Southern California Permanente Medical Group, Bellflower, United States

Marilyn Norton, M.D., Chula Vista, United States

Bay Area Cancer Research Group, LLC, Concord, United States

East Bay Oncology/Hematology Medical Associates, Inc., Concord, United States

Southwest Cancer Care, Escondido, United States

Southern California Permanente Medical Group, Fontana, United States

California Oncology of the Central Valley, Fresno, United States

Southern California Permanente Medical Group, Harbor City, United States

Kaiser Permanente Medical Center, Hayward, United States

Gynecologic Oncology Associates, La Jolla, United States

Cancer Center Oncology Medical Group, La Mesa, United States

LLU Faculty Medical Offices, Loma Linda, United States

Loma Linda University Medical Center, Loma Linda, United States

Southern California Permanente Medical Group, Los Angeles, United States

Bowyer Oncology Center, Los Angeles, United States

David Geffen School of Medicine at UCLA, Los Angeles, United States

OB/GYN Consult Suite, Los Angeles, United States

Beverly Oncology and Imaging, Montebello, United States

Clinical Trials and Research Associates, Inc., Montebello, United States

Oncology Care Medical Associates, Montebello, United States

Southwest Cancer Care, Murrieta, United States

Newport Imaging Center, Newport Beach, United States

Gynecologic Oncology Associates, Newport Beach, United States

Hoag Memorial Hospital Presbyterian, Newport Beach, United States

Kaiser Permanente Medical Center, Oakland, United States

N. County Oncology Medical, Oceanside, United States

Southern California Permanente Medical Group, Panorama City, United States

Southwest Cancer Care, Poway, United States

Southern California Permanente Medical Group, Riverside, United States

Kaiser Permanente Medical Center, Sacramento, United States

Medical Oncology Associates, San Diego, United States

Sharp Memorial Hospital - Investigational Pharmacy, San Diego, United States

Sharp Rees-Stealy, San Diego, United States

Kaiser Permanente Medical Center, San Francisco, United States

Oncology Care Medical Associates, San Gabriel, United States

Kaiser Permanente Medical Center, San Jose, United States

Kaiser Permanente Medical Center, Santa Clara, United States

Kaiser Permanente Medical Center, South San Francisco, United States

Kaiser Permanente Medical Center, Vallejo, United States

Kaiser Permanente Medical Center, Walnut Creek, United States

Diablo Valley Oncology & Hematology Medical Group, Inc., Walnut Creek, United States

Oncology Care Medical Associates, Whittier, United States

Southern Permanente Medical Group, Woodland Hills, United States

University of Connecticut Health Center/John Dempsey Hospital, Farmington, United States

The Center for Hematology-Oncology, Boca Raton, United States

Citrus Diagnostic Center, Crystal River, United States

Citrus Hematology and Oncology Center, Crystal River, United States

The Center for Hematology-Oncology, Delray Beach, United States

GYN Oncology Associates, Inc., Hollywood, United States

Citrus Hematology and Oncology Center, Inverness, United States

Citrus Memorial Hospital Radiology Dept., Inverness, United States

Florida Wellcare Alliance, LC, Inverness, United States

Shands Jacksonville Medical Center, Jacksonville, United States

Palm Beach Cancer Institute, Jupiter, United States

Cancer and Blood Disease Center, Lecanto, United States

Florida Hospital, Orlando, United States

Gynecology Oncology, Orlando, United States

Florida Hospital Memorial Division - Cancer Care Center, Ormond Beach, United States

Florida Hospital Memorial System, Ormond Beach, United States

Palm Beach Cancer Institute, Palm Beach Gardens, United States

GYN Oncology Associates, Inc., Pembroke Pines, United States

Palm Beach Cancer Institute, Wellington, United States

Palm Beach Cancer Institute, West Palm Beach, United States

Southeastern Gynecologic Oncology, Atlanta, United States

Southeastern Gynecologic Oncology, Lawrenceville, United States

Southeastern Gynecologic Oncology, Marietta, United States

Southeastern Gynecologic Oncology, Riverdale, United States

Memorial Health University Medical Center, Savannah, United States

Southeastern Gynecologic Oncology, Tucker, United States

Kaiser Permanente Hawaii, Honolulu, United States

Kapiolani Medical Center for Women and Children, Honolulu, United States

Joliet Oncology-Hematology Associates, Inc., Flossmoor, United States

Joliet Oncology-Hematology Associates, Inc., Joliet, United States

Joliet Oncology-Hematology Associates, Inc., Kankakee, United States

Joliet Oncology-Hematology Associates, Inc., Morris, United States

Elkhart General Hospital, Elkhart, United States

St. Vincent Hospital, Indianapolis, United States

LaPorte Hospital, La Porte, United States

Memorial Hospital of South Bend, South Bend, United States

Saint Joseph's Regional Medical Center, South Bend, United States

James Graham Brown Cancer Center, Louisville, United States

University Medical Center, Inc. DBA: U of L Hospital, Louisville, United States

Hematology and Oncology Specialists, LLC, Covington, United States

OncRx (Pharmacy), Metairie, United States

Hematology and Oncology Specialist, New Orleans, United States

LSU Health Sciences Center, Shreveport, United States

Maine Medical Center - Brighton Campus, Portland, United States

Maine Medical Center, Portland, United States

Maine Medical Center - Scarborough Campus, Scarborough, United States

Sinai Hospital of Baltimore, Baltimore, United States

Center for Cancer and Blood Disorders, P. C., Bethesda, United States

Massachusetts General Hospital, Boston, United States

Dana Farber/Partners Cancer Care, Inc., Boston, United States

Boston Medical Center - Center for Cancer and Blood Disorders, Boston, United States

Boston Medical Center, Boston, United States

Caritas St. Elizabeth's Medical Center, Boston, United States

Beth Israel Deaconess Medical Center, Boston, United States

Perceptive Informatics, Inc., Waltham, United States

Sparrow Health System, Lansing, United States

Lakeland Hospital, Niles, United States

Lakeland Hospital, Saint Joseph, United States

Providence Cancer Institute and Hospital, Southfield, United States

Duluth Clinic, Duluth, United States

The Family Cancer Center, Olive Branch, United States

Ellis Fischel Cancer Center, Columbia, United States

Saint Louis University, St Louis, United States

St. John's Mercy Medical Center, St Louis, United States

St. John's Mercy-David C. Pratt Cancer Center, St Louis, United States

Deaconess Billings Clinic, Billings, United States

Alegent Health Immanuel Medical Center, Omaha, United States

Hematology & Oncology Consultants, PC, Omaha, United States

Horizons West Medical Group, Scottsbluff, United States

Odyssey Research, Scottsbluff, United States

Regional West Medical Center, Scottsbluff, United States

The Women's Center of Western Nebraska, Scottsbluff, United States

Mary Hitchcock Memorial Hospital/Dartmouth-Hitchcock Medical Center, Lebanon, United States

A. Richard Miskoff, DO, PA, Edison, United States

JFK Medical Center, Edison, United States

Jersey Shore University Medical Center, Neptune City, United States

Robert Wood Johnson University Hospital, New Brunswick, United States

The Cancer Institute of New Jersey, New Brunswick, United States

Jsumc Ob/Gyn, West Long Branch, United States

Gynecologic Oncology & Minimally Invasive Surgery, Babylon, United States

The Mary Imogene Bassett Hospital, Cooperstown, United States

Schwartz Gynecologic Oncology, East Islip, United States

North Shore University Hospital, Manhasset, United States

Hematology-Oncology Associates of Rockland, New City, United States

Long Island Jewish Medical Center, New Hyde Park, United States

The Union State Bank Cancer Center, Nyack, United States

Asheville Radiology, Asheville, United States

Hope A Women's Cancer Center, Asheville, United States

University of North Carolina at Chapel Hill, Chapel Hill, United States

Carolinas Medical Center, Charlotte, United States

Inpatient Pharmacy, Charlotte, United States

Blumenthal Cancer Center, Charlotte, United States

Presbyterian Gynecologic Oncology, Charlotte, United States

Presbyterian Hospital, Charlotte, United States

Piedmont Hematology Oncology Associates, Winston-Salem, United States

Cancer Care Center - Medcenter One, Inc., Bismarck, United States

Cancer Treatment & Research Center - Mid Dakota Clinic, P. C., Bismarck, United States

Odyssey Research, Bismarck, United States

Dakota Cancer Institute, Fargo, United States

Odyssey Research, Fargo, United States

Barrett Cancer Center, Cincinnati, United States

UC Physician's Medical Arts Building, Cincinnati, United States

University of Cincinnati Medical Center, Cincinnati, United States

Fairview Hospital Moll Pavilion, Cleveland, United States

Mid Ohio Onc/Hem (East), Columbus, United States

GOPSA, Columbus, United States

Mid Ohio Onc/Hem (West), Columbus, United States

Miami Valley Hospital, Dayton, United States

Hillcrest Hospital/Cleveland Clinic Health System, Mayfield Heights, United States

Garth Phibbs, M.D., FACOG, Toledo, United States

ProMedica Health System, Toledo, United States

The Toledo Hospital, Toledo, United States

Mid Onio Onc/Hem (North), Westerville, United States

Cancer Care Associates, Tulsa, United States

Kaiser Permanente Northwest Region, Portland, United States

Oregon Health & Science University, Portland, United States

Abington Memorial Hospital, Abington, United States

Advance Imaging, Dunmore, United States

Hematology & Oncology Associates of NEPA, Dunmore, United States

Magee-Womens Hospital of UPMC, Pittsburgh, United States

Hematology & Oncology Associates of NEPA, Scranton, United States

Viewmont Medical Services, Scranton, United States

Community Medical Center, Scranton, United States

Mercy Health Partners, Scranton, United States

Moses Taylor Hospital, Scranton, United States

Associates in Hematology-Oncology, P.C., Upland, United States

Roper Hospital-Department of Radiology, Charleston, United States

Carolina Center of Gynecologic Oncology, PA, Charleston, United States

South Carolina Oncology, Columbia, United States

Greenville Hospital System, Greenville, United States

Spartanburg Regional Healthcare System, Spartanburg, United States

Sioux Valley Clinic - Clinical Research Center, Sioux Falls, United States

Sioux Valley Clinic Oncology, Sioux Falls, United States

Sioux Valley Hospital - North Center Radiology, Sioux Falls, United States

Sioux Valley Clinic OBGYN, Ltd., Sioux Falls, United States

The Family Cancer Center, Bartlett, United States

Baroness Erlander Hospital, Chattanooga, United States

Chattanooga GYN Oncology, Chattanooga, United States

Parkridge Medical Center, Chattanooga, United States

The Family Cancer Center, Collierville, United States

The Family Cancer Center, Memphis, United States

Arlington Cancer Center, Arlington, United States

Center for Oncology Research and Treatment, PA, Dallas, United States

Texas Cancer Associates, Dallas, United States

Texas Cancer Associates, Plano, United States

Center for Oncology Research and Treatment, PA, Richardson, United States

Danville Hematology and Oncology, Inc., Danville, United States

VCU Health System at Stony Point, Richmond, United States

VCU Health System-Dalton Oncology Clinic, North Hospital, Richmond, United States

Carilion GYN Oncology Associates, Roanoke, United States

Western Washington Oncology, Inc., P.S., Aberdeen, United States

Western Washington Oncology, Inc., P. S., Centralia, United States

Covington MultiCare - Oncology Clinic, Covington, United States

Gig Harbor Medical Oncology, Gig Harbor, United States

Western Washington Oncology, Inc., P.S., Lacey, United States

Western Washington Oncology, Inc., P.S., Shelton, United States

Allenmore Hospital - Hematology Oncology Clinic, Tacoma, United States

MultiCare Health System - Medical Oncology, Tacoma, United States

Marshfield Clinic - Chippewa Falls Center, Chippewa Falls, United States

Marshfield Clinic Cancer Care - Regional Cancer Center - Sacred Heart Hospital, Eau Claire, United States

Marshfield Clinic, Marshfield, United States

Marshfield Clinic - Lakeland Center, Minocqua, United States

Marshfield Clinic - Indianhead Center, Rice Lake, United States

St. Michael's Hospital, Stevens Point, United States

Marchfield Clinic - Wausau Center, Wausau, United States

Marshfield Clinic Weston Center, Weston, United States

Marshfield Clinic - Wisconsin Rapids Center, Wisconsin Rapids, United States

Linked Diseases

Ovarian Neoplasms

Ovarian Neoplasms — a type of gynecological cancer.

Linked Papers

2023-07-05

Pegylated liposomal doxorubicin for relapsed epithelial ovarian cancer

Cancer of ovarian, fallopian tube and peritoneal origin, referred to collectively as ovarian cancer, is the eighth most common cancer in women and is often diagnosed at an advanced stage. Women with relapsed epithelial ovarian cancer (EOC) are less well and have a limited life expectancy, therefore maintaining quality of life with effective symptom control is an important aim of treatment. However, the unwanted effects of chemotherapy agents may be severe, and optimal treatment regimens are unclear. Pegylated liposomal doxorubicin (PLD), which contains a cytotoxic drug called doxorubicin hydrochloride, is one of several treatment modalities that may be considered for treatment of relapsed EOCs. This is an update of the original Cochrane Review which was published in Issue 7, 2013. To evaluate the efficacy and safety of PLD, with or without other anti-cancer drugs, in women with relapsed high grade epithelial ovarian cancer (EOC). We searched CENTRAL, MEDLINE (via Ovid) and Embase (via Ovid) from 1990 to January 2022. We also searched online registers of clinical trials, abstracts of scientific meetings and reference lists of included studies. We included randomised controlled trials (RCTs) that evaluated PLD in women diagnosed with relapsed epithelial ovarian cancer. Two review authors independently extracted data to a pre-designed data collection form and assessed the risk of bias according to the Cochrane Handbook for Systematic Reviews of Interventions guidelines. Where possible, we pooled collected data in meta-analyses. This is an update of a previous review with 12 additional studies, so this updated review includes a total of 26 RCTs with 8277 participants that evaluated the effects of PLD alone or in combination with other drugs in recurrent EOC: seven in platinum-sensitive disease (2872 participants); 11 in platinum-resistant disease (3246 participants); and eight that recruited individuals regardless of platinum sensitivity status (2079 participants). The certainty of the evidence was assessed for the three most clinically relevant comparisons out of eight comparisons identified in the included RCTs. Recurrent platinum-sensitive EOC PLD with conventional chemotherapy agent compared to alternative combination chemotherapy likely results in little to no difference in overall survival (OS) (hazard ratio (HR) 0.93, 95% confidence interval (CI) 0.83 to 1.04; 5 studies, 2006 participants; moderate-certainty evidence) but likely increases progression-free survival (PFS) (HR 0.81, 95% CI 0.74 to 0.89; 5 studies, 2006 participants; moderate-certainty evidence). The combination may slightly improve quality of life at three months post-randomisation, measured using European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C30 (mean difference 4.80, 95% CI 0.92 to 8.68; 1 study, 608 participants; low-certainty evidence), but this may not represent a clinically meaningful difference. PLD in combination with another chemotherapy agent compared to alternative combination chemotherapy likely results in little to no difference in the rate of overall severe adverse events (grade ≥ 3) (risk ratio (RR) 1.11, 95% CI 0.95 to 1.30; 2 studies, 834 participants; moderate-certainty evidence). PLD with chemotherapy likely increases anaemia (grade ≥ 3) (RR 1.37, 95% CI 1.02 to 1.85; 5 studies, 1961 participants; moderate-certainty evidence). The evidence is very uncertain about the effect of PLD with conventional chemotherapy on hand-foot syndrome (HFS)(grade ≥ 3) (RR 4.01, 95% CI 1.00 to 16.01; 2 studies, 1028 participants; very low-certainty evidence) and neurological events (grade ≥ 3) (RR 0.38, 95% CI 0.20 to 0.74; 4 studies, 1900 participants; very low-certainty evidence). Recurrent platinum-resistant EOC PLD alone compared to another conventional chemotherapy likely results in little to no difference in OS (HR 0.96, 95% CI 0.77 to 1.19; 6 studies, 1995 participants; moderate-certainty evidence). The evidence is very uncertain about the effect of PLD on PFS (HR 0.94, 95% CI 0.85 to 1.04; 4 studies, 1803 participants; very low-certainty evidence), overall severe adverse events (grade ≥ 3) (RR ranged from 0.61 to 0.97; 2 studies, 964 participants; very low-certainty evidence), anaemia (grade ≥ 3) (RR ranged from 0.19 to 0.82; 5 studies, 1968 participants; very low-certainty evidence), HFS (grade ≥ 3) (RR ranged from 15.19 to 109.15; 6 studies, 2184 participants; very low-certainty evidence), and the rate of neurological events (grade ≥ 3)(RR ranged from 0.08 to 3.09; 3 studies, 1222 participants; very low-certainty evidence). PLD with conventional chemotherapy compared to PLD alone likely results in little to no difference in OS (HR 0.92, 95% CI 0.70 to 1.21; 1 study, 242 participants; moderate-certainty evidence) and it may result in little to no difference in PFS (HR 0.94, 95% CI 0.73 to 1.22; 2 studies, 353 participants; low-certainty evidence). The combination likely increases overall severe adverse events (grade ≥ 3) (RR 2.48, 95% CI 1.98 to 3.09; 1 study, 663 participants; moderate-certainty evidence) and anaemia (grade ≥ 3) (RR 2.38, 95% CI 1.46 to 3.87; 2 studies, 785 participants; moderate-certainty evidence), but likely results in a large reduction in HFS (grade ≥ 3) (RR 0.24, 95% CI 0.14 to 0.40; 2 studies, 785 participants; moderate-certainty evidence). It may result in little to no difference in neurological events (grade ≥ 3) (RR 1.40, 95% CI 0.85 to 2.31; 1 study, 663 participants; low-certainty evidence). In platinum-sensitive relapsed EOC, including PLD in a combination chemotherapy regimen probably makes little to no difference in OS compared to other combinations, but likely improves PFS. Choice of chemotherapy will therefore be guided by symptoms from previous chemotherapy and other patient considerations. Single-agent PLD remains a useful agent for platinum-resistant relapsed EOC and choice of agent at relapse will depend on patient factors, e.g. degree of bone marrow suppression or neurotoxicity from previous treatments. Adding another agent to PLD likely increases overall grade ≥ 3 adverse events with little to no improvement in survival outcomes. The limited evidence relating to PLD in combination with other agents in platinum-resistant relapsed EOC does not indicate a benefit, but there is some evidence of increased side effects.