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

• ClinicalTrials.gov Identifier: NCT00476086
• Recruitment Status: Completed
• First Posted: May 21, 2007
• Results First Posted: April 13, 2016
• Last Update Posted: August 24, 2018
• Sponsor: Dana-Farber Cancer Institute
• Collaborators: Sanofi; Brigham and Women's Hospital; Massachusetts General Hospital
• Information provided by (Responsible Party): Susana M. Campos, MD, Dana-Farber Cancer Institute

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Mixed Mullerian Tumors of the Uterus	Drug: Gemcitabine; Drug: Oxaliplatin; Radiation: Radiation	Phase 2

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 20 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Phase II Study of Oxaliplatin and Gemcitabine Followed by Radiation Therapy in the Management of Mixed Mullerian Tumors of the Uterus
• Study Start Date: August 2006
• Actual Primary Completion Date: March 2012
• Actual Study Completion Date: December 2015

Arms and Interventions

Arm	Intervention/treatment
Experimental: 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.	Drug: Gemcitabine; Other Name: Gemzar; Drug: Oxaliplatin; Other Name: Eloxatin; Radiation: Radiation

Outcome Measures

Primary Outcome Measures :

1. Chemotherapy Completion Rate [ Time Frame: 3 cycles of chemotherapy which approximates 3 months given the 28-day cycle ]
   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.

Secondary Outcome Measures :

1. Radiation Therapy Completion Rate [ Time Frame: Radiation therapy was within 4-6 weeks of last chemotherapy dose. Participants received up to 5 weeks of radiation therapy. ]
   Disease was evaluated radiologically at baseline and every X cycles on treatment; Treatment continued if radiological exam showed no progressive disease

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

United States, Massachusetts

Dana-Farber Cancer Institute

Boston, Massachusetts, United States, 02115

Massachusetts General Hospital

Boston, Massachusetts, United States, 02215

Sponsors and Collaborators

Dana-Farber Cancer Institute

Sanofi

Brigham and Women's Hospital

Massachusetts General Hospital

Investigators

• Principal Investigator: Susana Campos, MD; Dana-Farber Cancer Institute

More Information

• Responsible Party: Susana M. Campos, MD, Medical Oncologist, Dana-Farber Cancer Institute
• ClinicalTrials.gov Identifier: NCT00476086
• Other Study ID Numbers: 06-063
• First Posted: May 21, 2007
• Results First Posted: April 13, 2016
• Last Update Posted: August 24, 2018
• Last Verified: July 2018

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

Keywords provided by Susana M. Campos, MD, Dana-Farber Cancer Institute:

oxaliplatin; gemcitabine; MMMT

Additional relevant MeSH terms:

Mixed Tumor, Mullerian; Carcinosarcoma; Uterine Neoplasms; Neoplasms, Complex and Mixed; Neoplasms by Histologic Type; Neoplasms; Sarcoma; Neoplasms, Connective and Soft Tissue; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Uterine Diseases; Gemcitabine; Oxaliplatin; Antimetabolites, Antineoplastic; Antimetabolites; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Antiviral Agents; Anti-Infective Agents; Enzyme Inhibitors; Immunosuppressive Agents; Immunologic Factors; Physiological Effects of Drugs