Ixabepilone in Treating Patients With Ovarian Epithelial or Primary Peritoneal Cancer That Has Not Responded to Previous Chemotherapy

NCT00025155CompletedPHASE2INTERVENTIONAL

Summary

Phase II trial to study the effectiveness of ixabepilone in treating patients who have recurrent or persistent ovarian epithelial or primary peritoneal cancer that has not responded to previous chemotherapy. Drugs used in chemotherapy work in different ways to stop tumor cells from dividing so they stop growing or die.

Key Facts

Lead Sponsor

National Cancer Institute (NCI)

Enrollment

51

Start Date

2002-07-01

Completion Date

2010-03-01

Study Type

INTERVENTIONAL

Official Title

A Phase II Evaluation of Epothilone-B BMS 247550 (NSC # 710428) in the Treatment of Recurrent or Persistent Platinum and Paclitaxel Refractory Ovarian or Primary Peritoneal Cancer

Interventions

ixabepilone

Conditions

Primary Peritoneal Cavity CancerRecurrent Ovarian Epithelial Cancer

Eligibility

Sex

FEMALE

Inclusion Criteria:

* Histologically confirmed ovarian epithelial cancer or primary peritoneal cancer

  * Recurrent or persistent disease
  * Platinum AND taxane-resistant or refractory disease

    * Progressed during therapy
    * Refractory disease within 6 months of therapy
* Measurable disease

  * At least 20 mm by conventional techniques
  * At least 10 mm by spiral CT scan
  * Tumor lesions located within a previously irradiated field are not considered measurable disease unless there is documented tumor progression in these lesions or biopsy confirmation ≥ 90 days following completion of radiotherapy
* Ineligible for higher priority GOG (Gynecologic Oncology Group) protocol
* No active brain metastases
* Performance status - GOG 0-2
* Absolute neutrophil count ≥ 1,500/mm\^3
* Platelet count ≥ 100,000/mm\^3
* Bilirubin ≤ 1.5 times upper limit of normal (ULN)
* SGOT (serum glutamate oxaloacetate transaminase) ≤ 2.5 times ULN
* Alkaline phosphatase ≤ 2.5 times ULN
* Creatinine ≤ 1.5 times ULN
* No sensory or motor neuropathy \> grade 1
* No dementia or altered mental status
* No other serious uncontrolled medical disorder
* No active infection requiring antibiotics
* No prior hypersensitivity reaction to paclitaxel or other therapy containing Cremophor EL
* No other malignancy within the past 5 years except nonmelanoma skin cancer
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* At least 3 weeks since prior biologic therapy
* At least 3 weeks since prior immunotherapy
* Must have received:

  * 1 prior combination taxane-based and platinum-based chemotherapy regimen
  * 1 prior platinum-based chemotherapy regimen AND 1 prior taxane-based chemotherapy regimen
* Initial treatment may include high-dose therapy, consolidation, or extended therapy
* At least 3 weeks since prior chemotherapy and recovered
* No prior ixabepilone
* No other prior cytotoxic chemotherapy for recurrent or persistent disease, including treatment with initial regimen
* At least 1 week since prior hormonal anticancer therapy
* Concurrent hormone replacement therapy allowed
* At least 3 weeks since prior radiotherapy and recovered
* No prior radiotherapy to site(s) of measurable disease
* No radiotherapy to \> 25% of marrow-containing areas
* Recovered from recent surgery
* At least 3 weeks since other anticancer therapy
* No prior anticancer therapy that precludes study participation
* No concurrent food supplements (e.g., St. John's wort)
* No concurrent amifostine or other protective agents

Outcome Measures

Primary Outcomes

Tumor Response

Percentage of participants with complete and partial tumor response as assessed by the Gynecologic Oncology Group Response Evaluation Criteria in Solid Tumors (GOG RECIST) with one-sided 90% Confidence Interval. Complete Response (CR), disappearance of all target and non-target lesions without evidence of new lesion; Partial Response (PR), \>=30% decrease in the sum of the longest dimensions (LD) of all target measurable lesions taking as reference the baseline sum of LD with no unequivocal progression of non-target lesions and no evidence of new lesion, or a 50% decrease in the LD in the case where the ONLY target lesion is a solitary pelvic mass measured by physical exam with no unequivocal progression of non-target lesions and no evidence of new lesion. Complete or partial response requires confirmation at greater than or equal to 4 weeks from initial documentation.

Time frame: Every other cycle until the completion of study treatment with an average of study treatment time as of 3 months.

Number of People With Adverse Effects

Time frame: Every cycle until completion of study treatment up to 30 days after stopping study treatment

Secondary Outcomes

Progression Free Survival

Progression-Free Survival is the period from study entry until disease progression, death or date of last contact, whichever occurs first. Progression is defined as at least a 20% increase in the sum of the longest dimensions (LD) of target lesions taking as reference the smallest sum LD recorded since study entry, or a 50% increase in the LD taking as reference the smallest LD recorded since study entry in the case where the ONLY target lesion is a solitary pelvic mass measured by physical exam, or unequivocal progression of existing non-target lesions, or the appearance of one or more new lesions, or global deterioration in health status attributable to the disease requiring a change in therapy without objective evidence of progression, or death due to disease without prior objective documentation of progression.

Time frame: From study entry to disease progression, death or date of last contact, whichever occurs first. Every other cycle, up to 5 years of follow-up

Overall Survival

Overall survival is defined as the duration of time from study entry to time of death or the date of last contact.

Time frame: From study entry to death or last contact, up to 5 years of follow-up.

Locations

Gynecologic Oncology Group, Philadelphia, United States

Ixabepilone in Treating Patients With Ovarian Epithelial or Primary Peritoneal Cancer That Has Not Responded to Previous Chemotherapy