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A Phase II Evaluation of Ixabepilone (BMS-247550) [NCI-Supplied Agent, IND #59699, NSC #710428]) in the Treatment of Recurrent or Persistent Endometrial Carcinoma


Phase 2
N/A
N/A
Not Enrolling
Female
Endometrial Adenocarcinoma, Recurrent Endometrial Carcinoma, Stage IV Endometrial Carcinoma

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Trial Information

A Phase II Evaluation of Ixabepilone (BMS-247550) [NCI-Supplied Agent, IND #59699, NSC #710428]) in the Treatment of Recurrent or Persistent Endometrial Carcinoma


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.


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 ≤ 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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Frequency and duration of objective response

Outcome Time Frame:

Up to 5 years

Safety Issue:

No

Principal Investigator

Don Dizon

Investigator Role:

Principal Investigator

Investigator Affiliation:

Gynecologic Oncology Group

Authority:

United States: Food and Drug Administration

Study ID:

NCI-2012-02628

NCT ID:

NCT00095979

Start Date:

May 2005

Completion Date:

Related Keywords:

  • Endometrial Adenocarcinoma
  • Recurrent Endometrial Carcinoma
  • Stage IV Endometrial Carcinoma
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous
  • Carcinoma
  • Adenoma
  • Endometrial Neoplasms

Name

Location

Gynecologic Oncology GroupPhiladelphia, Pennsylvania  19103