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

This study has been completed.
Sponsor:
Collaborators:
Sanofi
Brigham and Women's Hospital
Massachusetts General Hospital
Information provided by (Responsible Party):
Susana M. Campos, MD, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier:
NCT00476086
First received: May 17, 2007
Last updated: May 5, 2016
Last verified: May 2016
  Purpose
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 Intervention Phase
Mixed Mullerian Tumors of the Uterus
Drug: Gemcitabine
Drug: Oxaliplatin
Radiation: Radiation
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Dana-Farber Cancer Institute:

Primary Outcome Measures:
  • Chemotherapy Completion Rate [ Time Frame: 3 cycles of chemotherapy which approximates 3 months given the 28-day cycle ] [ Designated as safety issue: No ]
    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:
  • 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. ] [ Designated as safety issue: Yes ]
    Disease was evaluated radiologically at baseline and every X cycles on treatment; Treatment continued if radiological exam showed no progressive disease


Enrollment: 20
Study Start Date: August 2006
Study Completion Date: December 2015
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00476086

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     History of Changes
Other Study ID Numbers: 06-063 
Study First Received: May 17, 2007
Results First Received: March 10, 2016
Last Updated: May 5, 2016
Health Authority: United States: Institutional Review Board
Individual Participant Data  
Plan to Share IPD: No

Keywords provided by Dana-Farber Cancer Institute:
oxaliplatin
gemcitabine
MMMT

Additional relevant MeSH terms:
Uterine Neoplasms
Carcinosarcoma
Mixed Tumor, Mullerian
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Diseases
Genital Diseases, Female
Neoplasms, Complex and Mixed
Neoplasms by Histologic Type
Sarcoma
Neoplasms, Connective and Soft Tissue
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

ClinicalTrials.gov processed this record on December 02, 2016