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OCRA indexes clinical trials from ClinicalTrials.gov, the official U.S. registry maintained by the National Library of Medicine. Trials are matched to diseases, investigators, and funded research tracked across the platform.

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Search by condition, treatment type, trial phase, or NCT identifier. Each trial page shows current status, eligibility criteria, study locations, and a direct link to the ClinicalTrials.gov source record.

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A Study of Carboplatin and DOXIL Plus Bevacizumab in Patients With Platinum Sensitive Recurrent Ovarian, Fallopian Tube and Primary Peritoneal Cancers

NCT00698451CompletedPHASE2INTERVENTIONAL

Summary

The purpose of this study is to evaluate the response rate (Complete Response (CR) and Partial Response (PR)) to carboplatin and DOXIL treatment in combination with bevacizumab in patients with platinum-sensitive recurrent ovarian, fallopian tube and primary peritoneal cancers. All patients will received DOXIL, carboplatin and bevacizumab for a maximum of ten 28-day cycles. Patients will be followed for six months following treatment to assess progression-free survival.

Key Facts

Lead Sponsor

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Enrollment

Start Date

2008-08-01

Completion Date

2010-10-01

Study Type

INTERVENTIONAL

Official Title

A Phase II Single Arm Study of Carboplatin and DOXIL (PLD) Plus Bevacizumab in Patients With Platinum Sensitive Recurrent Ovarian, Fallopian Tube and Primary Peritoneal Cancers

Interventions

doxorubicin HCL liposome; bevacizumab; carboplatin

Conditions

Ovarian NeoplasmsFallopian Tube NeoplasmsPeritoneal Neoplasms

Eligibility

Age Range

18 Years+

Sex

FEMALE

Inclusion Criteria:

* Histologic diagnosis of epithelial ovarian, fallopian tube or primary peritoneal cancer
* Relapse-free interval of \>6 months afer completion of first line platinum-based chemotherapy
* Measurable disease (at least one lesion that can be accurately measured in a least 1 dimension)
* Adequate bone marrow function, renal, and liver function. Normal cardiac function
* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.

Exclusion Criteria:

* No patients who have received more than 1 previous regimen of chemotherapy (maintenance is not considered a second regimen)
* No patients receiving immunotherapy or radiotherapy or patients who have received prior radiotherapy to any portion of the abdominal cavity or pelvis
* No patients who require parenteral hydration or nutrition or have clinical signs or symptoms of gastrointestinal bowel obstruction or perforation
* No patients with previous or current malignancy other than basal cell or squamous cell carcinoma of the skin
* No patients with clinically significant cardiovascular disease
* No patients with a history of bevacizumab or other VEGF or VEGF receptor-targeted agent use.

Outcome Measures

Primary Outcomes

The Primary Efficacy End Point is the Number of Patients With an Objective Response.

Objective Response Rate to Treatment is defined as the Proportion of Patients With a Complete Response (CR) or Partial Response (PR). A Complete Response (CR) is the disappearance of all target lesions and a Partial Response is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD

Time frame: Approximately 280 days (from start of treatment to the end of 10 cycles of treatment where each cycle is 28 days)

Secondary Outcomes

The Secondary Efficacy Endpoints is Duration of Objective Response.

Objective Response Rate to Treatment Defined as the Proportion of Patients With a Complete Response (CR) or Partial Response (PR) Where a Complete response (CR) is the disappearance of all target lesions and a Partial Response is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD. Duration of response: Duration of response was defined only for subjects with CR or PR as the best overall response. It was calculated from the date of first documentation of response to the date of disease progression or death due to progressive disease.

Time frame: Duration of response was defined only for subjects with CR or PR as the best overall response. It was calculated from the date of first documentation of response to the date of disease progression or death due to progressive disease.

Locations

Horsham, United States

Linked Diseases

Ovarian Neoplasms

Ovarian Neoplasms — a type of gynecological cancer.