Ixabepilone in Treating Patients With Recurrent or Persistent Endometrial Cancer

NCT ID: NCT00095979

Last Updated: 2019-07-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 52 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-05-31
• Study Completion Date: 2009-07-31

Brief Summary

Drugs used in chemotherapy, such as ixabepilone, work in different ways to stop tumor cells from dividing so they stop growing or die. This phase II trial is studying how well ixabepilone works in treating patients with recurrent or persistent endometrial cancer.

Detailed Description

PRIMARY OBJECTIVES:

I. Determine the response rate in patients with recurrent or persistent endometrial adenocarcinoma treated with ixabepilone.

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

OUTLINE: This is a multicenter study.

Patients receive ixabepilone IV over 3 hours on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

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

PROJECTED ACCRUAL: A total of 19-51 patients will be accrued for this study within 2.5 years.

Conditions

Endometrial Adenocarcinoma; Recurrent Endometrial Carcinoma; Stage IV Endometrial Carcinoma

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 3 hours on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

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 endometrial adenocarcinoma

• Recurrent or persistent disease

• Histologic confirmation of the original primary tumor is required
• Not amenable to management with any of the following:

• Surgery
• Radiotherapy
• Higher priority or standard chemotherapy
• Measurable disease

• At least 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques (e.g., palpation, plain x-ray, CT scan, or MRI) OR ≥ 10 mm by spiral CT scan
• At least 1 target lesion

• Tumors within a previously irradiated field are designated as non-target lesions
• Disease in an irradiated field as the only site of measurable disease is acceptable as a target lesion only if there has been clear progression of the lesion at least 90 days after completion of radiotherapy
• Received 1, and only 1, prior chemotherapy regimen (e.g., high-dose therapy, consolidation, or extended therapy administered after surgery or non-surgical assessment) for management of endometrial adenocarcinoma
• Ineligible for a higher priority Gynecologic Oncology Group (GOG) protocol (e.g., any active GOG phase III study for the same patient population)
• 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)
• AST (aspartate aminotransferase) ≤ 2.5 times ULN
• Alkaline phosphatase ≤ 2.5 times ULN
• Creatinine ≤ 1.5 times ULN
• Sensory or motor neuropathy ≤ grade 1
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception
• No active infection requiring antibiotics
• No other invasive malignancies within the past 5 years except non-melanoma skin cancer
• At least 3 weeks since prior biologic or immunologic agents directed at the malignant tumor
• One prior non-cytotoxic* (biologic or cytostatic) regimen for management of recurrent or persistent disease allowed
• See Disease Characteristics
• Prior paclitaxel or docetaxel allowed
• Recovered from prior chemotherapy
• No more than 1 prior cytotoxic chemotherapy regimen (either single or combination drug therapy)
• No prior ixabepilone
• At least 1 week since prior hormonal therapy directed at the malignant tumor

• Continuation of hormone replacement therapy allowed
• See Disease Characteristics
• Recovered from prior radiotherapy
• Recovered from prior surgery
• At least 3 weeks since other prior therapy directed at the malignant tumor
• No prior cancer treatment that contraindicates study therapy

• 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

Don Dizon

Role: PRINCIPAL_INVESTIGATOR

Gynecologic Oncology Group

Locations

Gynecologic Oncology Group

Philadelphia, Pennsylvania, United States

Countries

United States

Other Identifiers

NCI-2012-02628

Identifier Type: REGISTRY

Identifier Source: secondary_id

CDR0000391849

Identifier Type: -

Identifier Source: secondary_id

GOG-0129P

Identifier Type: OTHER

Identifier Source: secondary_id

GOG-0129P

Identifier Type: OTHER

Identifier Source: secondary_id

U10CA027469

Identifier Type: NIH

Identifier Source: secondary_id

View Link

NCI-2012-02628

Identifier Type: -

Identifier Source: org_study_id