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

NCT ID: NCT00025155

Last Updated: 2019-07-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 51 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-07-31
• Study Completion Date: 2010-03-31

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.

Conditions

Primary Peritoneal Cavity Cancer; Recurrent Ovarian Epithelial Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment (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.

Group Type: EXPERIMENTAL

ixabepilone

Intervention Type: DRUG

Given IV

Interventions

ixabepilone

Given IV

Intervention Type: DRUG

Other Intervention Names

BMS-247550; epothilone B lactam; Ixempra

Eligibility Criteria

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

• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Gynecologic Oncology Group

NETWORK

Sponsor Role: collaborator

National Cancer Institute (NCI)

NIH

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

David R. Spriggs

Role: PRINCIPAL_INVESTIGATOR

Gynecologic Oncology Group

Locations

Gynecologic Oncology Group

Philadelphia, Pennsylvania, United States

Countries

United States

Other Identifiers

NCI-2012-02413

Identifier Type: REGISTRY

Identifier Source: secondary_id

CDR0000068927

Identifier Type: -

Identifier Source: secondary_id

GOG-0126M

Identifier Type: OTHER

Identifier Source: secondary_id

GOG-0126M

Identifier Type: OTHER

Identifier Source: secondary_id

U10CA027469

Identifier Type: NIH

Identifier Source: secondary_id

View Link

NCI-2012-02413

Identifier Type: -

Identifier Source: org_study_id