Clinical trial NCT00095979: Ixabepilone in Treating Patients With Recurrent or Persistent Endometrial Cancer
Official title: A Phase II Evaluation of Ixabepilone (BMS-247550) [NCI-Supplied Agent, NSC #710428]) in the Treatment of Recurrent or Persistent Endometrial Carcinoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Endometrial Adenocarcinoma
Recurrent Endometrial Carcinoma
Stage IV Endometrial Carcinoma
Lead sponsor: National Cancer Institute (NCI)
Sponsor class: NIH
Collaborators: name: Gynecologic Oncology Group
First posted: 2004-11-09
Enrollment: 52
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Tumor Response
timeFrame: Every other cycle for first 6 months; then every six months thereafter until completion of study treatment; and at any other time if clinically indicated based on symptoms or physical signs suggestive of progressive disease
measure: Frequency and Severity of Observed Adverse Effects Associated With Protocol Therapy (CTCAE Version 3)
timeFrame: Every cycle until completion of study treatment up to 30 days after stopping study treatment (average length of data collection = 4 months)
Secondary outcomes:
measure: Progression-free Survival
timeFrame: From study entry to disease progression, death or date of last contact, whichever occurs first, up to 5 years of follow-up.
measure: Overall Survival
timeFrame: From study entry to death or last contact, up to 5 years of follow-up.
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Gynecologic Oncology Group
state: Pennsylvania
Study officials:
affiliation: Gynecologic Oncology Group
name: Don Dizon
role: PRINCIPAL_INVESTIGATOR
References: