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

This study is ongoing, but not recruiting participants.
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: August 23, 2013
Last verified: August 2013
  Purpose

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.


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:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To describe the response rate by Response Evaluation Criteria in Solid Tumors [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  • Determine time to progression [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • To determine the safety profile of this dual modality treatment [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 24
Study Start Date: August 2006
Estimated Study Completion Date: September 2013
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Gemcitabine
    Given intravenously on the first and third week of each 4 week cycle
    Drug: Oxaliplatin
    Given intravenously on the first and third week of each 4 week cycle
    Radiation: Radiation
    After 3 cycles of treatment with oxaliplatin and gemcitabine, radiation therapy will be given five days a week for five weeks
Detailed 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.
  Eligibility

Ages Eligible for Study:   18 Years and older
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

No publications provided

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
Last Updated: August 23, 2013
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Uterine Neoplasms
Mixed Tumor, Mullerian
Carcinosarcoma
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
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Radiation-Sensitizing Agents

ClinicalTrials.gov processed this record on October 19, 2014