Ixabepilone in Treating Patients With Recurrent or Persistent Endometrial Cancer

National Cancer Institute (NCI)

Status and phase

Completed

Phase 2

Conditions

Endometrial Adenocarcinoma

Recurrent Endometrial Carcinoma

Stage IV Endometrial Carcinoma

Treatments

Drug: ixabepilone

Study type

Interventional

Funder types

NETWORK

NIH

Identifiers

NCT00095979

U10CA027469 (U.S. NIH Grant/Contract)

GOG-0129P (Other Identifier)

NCI-2012-02628 (Registry Identifier)

CDR0000391849

Details and patient eligibility

About

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.

Full 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.

Enrollment

52 patients

Sex

Female

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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