Oxaliplatin and Gemcitabine Followed by Radiation Therapy in the Management of Mixed Mullerian Tumors of the Uterus

NCT ID: NCT00476086

Last Updated: 2018-08-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-08-31
• Study Completion Date: 2015-12-31

Brief Summary

The purpose of this research study is to determine the feasibility and safety of giving the combination of oxaliplatin and gemcitabine followed by radiation therapy and to learn whether or not this drug combined with radiation therapy works in treating women with Mullerian tumors of the uterus.

Detailed Description

OBJECTIVES:

Primary To determine the feasibility of dual modality therapy described as cytotoxic therapy followed by radiation therapy for the management of Malignant Mixed Mullerian Tumors (MMMTs).

Secondary

• To describe the response rate by Response Evaluation Criteria in Solid Tumors

STATISTICAL DESIGN:

This study used a two-stage design to evaluate feasibility of oxaliplatin and gemcitabine prior to radiation therapy defined as completing 3 cycles of chemotherapy. The null and alternative therapy completion rates were 25% and 50%. If 3 or more participants enrolled in the stage one cohort (n=9 participants) complete therapy than accrual would proceed to stage two (n=15 participants). If therapy was completed by at least 10 participants in the final set of 24 evaluable participants then this regimen would be deemed worthy of further study. This design had 80% power given one-sided type I error of 5% with the probability of stopping early 0.60.

Conditions

Mixed Mullerian Tumors of the Uterus

Study Design

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

Study Groups

Oxaliplatin/ Gemcitabine Then Radiation

Patients rcvd IV chemotherapy on days 1 and 15 of a 4-week cycle: gemcitabine 1000 mg/m2 and oxaliplatin 65 mg/m2 for up to 3 cycles. Two dose reductions per study drug were permitted. On study, chemotherapy was followed by radiation therapy (RT) within 4-6 weeks of last chemotherapy. RT regimen was tumor-volume directed.

Group Type: EXPERIMENTAL

Gemcitabine

Intervention Type: DRUG

Oxaliplatin

Intervention Type: DRUG

Radiation

Intervention Type: RADIATION

Interventions

Gemcitabine

Intervention Type: DRUG

Oxaliplatin

Intervention Type: DRUG

Radiation

Intervention Type: RADIATION

Other Intervention Names

Gemzar; Eloxatin

Eligibility Criteria

Inclusion Criteria

• Surgically staged and histologically confirmed diagnosis of MMMT
• 18 years of age or older
• ECOG Performance Score of 0-2
• Adequate bone marrow function
• Adequate renal function
• Adequate hepatic function
• Patients must be recovered from both the acute and late effects of any prior surgery

Exclusion Criteria

• Patients with an active infection
• Patients with CNS metastases
• History of prior malignancy within the past 5 years except curatively treated basal cell carcinoma of the skin, or cervical intraepithelial neoplasia
• Known hypersensitivity to any of the components of oxaliplatin or gemcitabine
• Prior radiation to the pelvis
• Patients who are receiving concurrent investigational therapy or who have received investigational therapy within 30 days
• Peripheral neuropathy greater or equal to Grade 2
• Stage IV visceral disease (lung and liver metastases at presentation)
• Any other medical condition, including mental illness or substance abuse, deemed by the investigator to be likely to interfere with a patient's ability to sign informed consent
• Known HIV or Hepatitis B or C (active, previously treated or both)
• Pregnant or breast feeding

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Sanofi

INDUSTRY

Sponsor Role: collaborator

Brigham and Women's Hospital

OTHER

Sponsor Role: collaborator

Massachusetts General Hospital

OTHER

Sponsor Role: collaborator

Dana-Farber Cancer Institute

OTHER

Sponsor Role: lead

Responsible Party

Susana M. Campos, MD

Medical Oncologist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Susana Campos, MD

Role: PRINCIPAL_INVESTIGATOR

Dana-Farber Cancer Institute

Locations

Dana-Farber Cancer Institute

Boston, Massachusetts, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

06-063

Identifier Type: -

Identifier Source: org_study_id