Gemcitabine and Docetaxel in Treating Patients With Recurrent or Persistent Uterine Cancer

NCT ID: NCT00114218

Last Updated: 2019-01-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-03-31

Brief Summary

This phase II trial is studying how well giving gemcitabine together with docetaxel works in treating patients with recurrent or persistent uterine cancer. Drugs used in chemotherapy, such as gemcitabine and docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.

Detailed Description

OBJECTIVES:

I. Determine the antitumor activity of gemcitabine and docetaxel in patients with recurrent or persistent uterine carcinosarcoma.

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

OUTLINE: This is a non-randomized, multicenter study. Patients receive gemcitabine IV over 30 minutes followed by docetaxel IV over 1 hour on days 1, 8, and 15. Courses repeat every 28 days in the absence of unacceptable toxicity or disease progression.

After completion of study treatment, patients are followed every 3 months for 2 years and then every 6 months for 3 years.

PROJECTED ACCRUAL: A total of 22-60 patients will be accrued for this study within 1-4 years.

Conditions

Recurrent Uterine Corpus Sarcoma; Uterine Carcinosarcoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment (gemcitabine hydrochloride, docetaxel)

Patients receive gemcitabine IV over 30 minutes followed by docetaxel IV over 1 hour on days 1, 8, and 15. Courses repeat every 28 days in the absence of unacceptable toxicity or disease progression.

Group Type: EXPERIMENTAL

Gemcitabine Hydrochloride

Intervention Type: DRUG

Given IV

Docetaxel

Intervention Type: DRUG

Given IV

Interventions

Gemcitabine Hydrochloride

Given IV

Intervention Type: DRUG

Docetaxel

Given IV

Intervention Type: DRUG

Other Intervention Names

dFdC; dFdCyd; TXT

Eligibility Criteria

Inclusion Criteria

• Histologically confirmed uterine carcinosarcoma

• Malignant mixed Müllerian tumor, homologous or heterologous type
• Recurrent or persistent disease

• Progressive disease after prior local therapy
• Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR ≥ 10 mm by spiral CT scan

• At least 1 target lesion
• Tumors within a previously irradiated field are not considered target lesions except documented progression or biopsy to confirm persistence at least 90 days after completion of radiation therapy
• Received 1, and only 1, prior chemotherapy regimen for carcinosarcoma

• Initial treatment may have included high-dose therapy, consolidation, or extended therapy administered after surgical or non-surgical assessment
• Ineligible for higher priority GOG protocol (i.e., any active phase III GOG protocol 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 normal (ULN)
• SGOT ≤ 2.5 times ULN
• Alkaline phosphatase ≤ 2.5 times ULN
• Creatinine ≤ 1.5 times ULN
• No severe pulmonary disease requiring oxygen supplementation
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception
• No active infection requiring antibiotics
• No other invasive malignancy within the past 5 years except nonmelanoma skin cancer
• No neuropathy (sensory or motor) > grade 1
• At least 3 weeks since prior biologic therapy or immunotherapy for the malignancy
• No more than 1 prior non-cytotoxic (biologic or cytostatic) regimen (e.g., monoclonal antibodies, cytokines, or small molecule inhibitors of signal transduction) for recurrent or persistent disease
• Recovered from prior chemotherapy
• No more than 1 prior cytotoxic chemotherapy regimen, either as a single agent or combination therapy
• No prior docetaxel or gemcitabine
• At least 1 week since prior hormonal therapy for the malignancy
• Concurrent hormone replacement therapy allowed
• Recovered from prior radiotherapy
• Recovered from prior surgery
• At least 3 weeks since other prior therapy for the malignancy
• No prior cancer treatment that would preclude study therapy

• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Gynecologic Oncology Group

NETWORK

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Brigitte Miller

Role: PRINCIPAL_INVESTIGATOR

Gynecologic Oncology Group

Locations

Gynecologic Oncology Group

Philadelphia, Pennsylvania, United States

Countries

United States

Other Identifiers

NCI-2012-02680

Identifier Type: REGISTRY

Identifier Source: secondary_id

CDR0000434843

Identifier Type: -

Identifier Source: secondary_id

GOG-0130E

Identifier Type: OTHER

Identifier Source: secondary_id

GOG-0130E

Identifier Type: OTHER

Identifier Source: secondary_id

U10CA027469

Identifier Type: NIH

Identifier Source: secondary_id

View Link

GOG-0130E

Identifier Type: -

Identifier Source: org_study_id