Ixabepilone in Treating Patients With Recurrent or Persistent Endometrial Cancer

NCT00095979 | Completed Phase 2 Results

• 4 other identifiers: NCI-2012-02628CDR0000391849GOG-0129PU10CA027469
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

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.

Conditions

Endometrial Adenocarcinoma; Recurrent Endometrial Carcinoma; Stage IV Endometrial Carcinoma

Outcome Measures

Primary Outcomes (2)

• Tumor Response

  RECIST 1.0 defines complete response as the disappearance of all target lesions and non-target lesions and no evidence of new lesions documented by two disease assessments at least 4 weeks apart. Partial response is defined as at least a 30% decrease in the sum of longest dimensions (LD) of all target measurable lesions taking as reference the baseline sum of LD. There can be no unequivocal progression of non-target lesions and no new lesions. Documentation by two disease assessments at least 4 weeks apart is required. In the case where the ONLY target lesion is a solitary pelvic mass measured by physical exam, which is not radiographically measurable, a 50% decrease in the LD is required. These patients will have their response classified according to the definitions stated above. Complete and partial responses are included in the objective tumor response rate.

  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

• Frequency and Severity of Observed Adverse Effects Associated With Protocol Therapy (CTCAE Version 3)

  Every cycle until completion of study treatment up to 30 days after stopping study treatment (average length of data collection = 4 months)

Secondary Outcomes (2)

• Progression-free Survival

  From study entry to disease progression, death or date of last contact, whichever occurs first, up to 5 years of follow-up.

• Overall Survival

  From study entry to death or last contact, up to 5 years of follow-up.

Study Arms (1)

Treatment (ixabepilone)

EXPERIMENTAL

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

Drug: ixabepilone

Interventions

ixabepilone DRUG

Given IV

Also known as: BMS-247550, epothilone B lactam, Ixempra

Treatment (ixabepilone)

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• National Cancer Institute (NCI): lead
• Gynecologic Oncology Group: collaborator

Study Sites (1)

Gynecologic Oncology Group

Philadelphia, Pennsylvania, 19103, United States

Location

MeSH Terms

Conditions

Endometrial Neoplasms

Interventions

ixabepilone

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Results Point of Contact

• Title: Angela M. Kuras, Associate Director of Data Management
• Organization: NRG Oncology Statistics and Data Management Center - Buffalo

kurasa@nrgoncology.org

716-845-7733

Study Officials

• Don Dizon

  Gynecologic Oncology Group

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 9, 2004
• First Posted: November 9, 2004
• Study Start: May 1, 2005
• Primary Completion: July 1, 2009
• Study Completion: July 1, 2009
• Last Updated: July 24, 2019
• Results First Posted: May 21, 2015

Record last verified: 2019-07

Locations

US (1)