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

Phase 2

Completed

Conditions: Primary Peritoneal Cavity Cancer
Recurrent Ovarian Epithelial Cancer

Interventions: Drug: ixabepilone

Registration Number: NCT00025155

Lead Sponsor: National Cancer Institute (NCI)

Brief 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.

Detailed Description: PRIMARY OBJECTIVES:

I. Determine the antitumor activity of ixabepilone in patients with recurrent or persistent platinum and paclitaxel-refractory ovarian epithelial or primary peritoneal cancer.

II. Determine the nature and degree of toxicity of this drug in these patients.

OUTLINE:

Patients receive ixabepilone IV over 1 hour. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity. Patients with a complete response (CR) receive 2 additional courses after achieving CR.

Patients are followed every 3 months for 2 years and then every 6 months for 3 years.

Recruitment & Eligibility

Status: COMPLETED

Sex: Female

Target Recruitment: 51

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

Exclusion Criteria

Not provided

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment (ixabepilone)	ixabepilone	Patients receive ixabepilone IV over 1 hour. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity. Patients with a complete response (CR) receive 2 additional courses after achieving CR.

Primary Outcome Measures

Name	Time	Method
Number of People With Adverse Effects	Every cycle until completion of study treatment up to 30 days after stopping study treatment
Tumor Response	Every other cycle until the completion of study treatment with an average of study treatment time as of 3 months.	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.

Secondary Outcome Measures

Name	Time	Method
Progression Free Survival	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	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.
Overall Survival	From study entry to death or last contact, up to 5 years of follow-up.	Overall survival is defined as the duration of time from study entry to time of death or the date of last contact.