Overview

This trial is active, not recruiting.

Condition mixed mullerian tumors of the uterus
Treatments gemcitabine, oxaliplatin, radiation
Phase phase 2
Sponsor Dana-Farber Cancer Institute
Collaborator Sanofi
Start date August 2006
End date September 2013
Trial size 24 participants
Trial identifier NCT00476086, 06-063

Summary

The purpose of this research study is to determine the 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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment

Primary Outcomes

Measure
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).
time frame: 2 years

Secondary Outcomes

Measure
To describe the response rate by Response Evaluation Criteria in Solid Tumors
time frame: 2 years
Determine time to progression
time frame: 2 years
To determine the safety profile of this dual modality treatment
time frame: 2 years

Eligibility Criteria

Female participants at least 18 years old.

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

Additional Information

Official title A Phase II Study of Oxaliplatin and Gemcitabine Followed by Radiation Therapy in the Management of Mixed Mullerian Tumors of the Uterus
Principal investigator Susana Campos, MD
Description - Each treatment cycle lasts four weeks during which time participants will receive oxaliplatin and gemcitabine the first week and the third week. During the second and fourth week, they will not receive the study medication. - After three cycles of chemotherapy treatment, participants will then get radiation therapy five days a week for five weeks. - At the start of each cycle participants will have a physical exam and be asked questions about their general health and specific questions about any problems that they might be having and any medications they may be taking. - Prior to each chemotherapy treatment they will also have the following: blood tests and neurology exam. After three cycles of treatment they will have an assessment of their tumor by x-ray, CT scan, or MRI. - After the final radiation treatment, CT scans will be done every three months for up to two years.
Trial information was received from ClinicalTrials.gov and was last updated in August 2013.
Information provided to ClinicalTrials.gov by Dana-Farber Cancer Institute.