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

Mixed Mullerian Tumors of the Uterus Clinical Trial

Official title:

A Phase II Study of Oxaliplatin and Gemcitabine Followed by Radiation Therapy in the Management of Mixed Mullerian Tumors of the Uterus

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00476086
• Other study ID #: 06-063
• Status: Completed
• Phase: Phase 2
• Start date: August 2006
• Est. completion date: December 2015

Study information

• Verified date: July 2018
• Source: Dana-Farber Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: December 2015
• Est. primary completion date: March 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinosarcoma
• Mixed Mullerian Tumors of the Uterus
• Mixed Tumor, Mullerian
• Uterine Neoplasms

Intervention

Drug:
• Gemcitabine

• Oxaliplatin

Radiation:
• Radiation

Locations

Country	Name	City	State
United States	Dana-Farber Cancer Institute	Boston	Massachusetts
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (4)

Lead Sponsor	Collaborator
Dana-Farber Cancer Institute	Brigham and Women's Hospital, Massachusetts General Hospital, Sanofi

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Chemotherapy Completion Rate	Feasibility in this study was based on the chemotherapy regimen. The chemotherapy completion rate is defined as the percentage of patients who complete 3 cycles of oxaliplatin and gemcitabine chemotherapy prior to radiation therapy.	3 cycles of chemotherapy which approximates 3 months given the 28-day cycle
Secondary	Radiation Therapy Completion Rate	Disease was evaluated radiologically at baseline and every X cycles on treatment; Treatment continued if radiological exam showed no progressive disease	Radiation therapy was within 4-6 weeks of last chemotherapy dose. Participants received up to 5 weeks of radiation therapy.