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

May 17, 2007
August 23, 2013
August 2006
September 2013   (final data collection date for primary outcome 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 ] [ Designated as safety issue: No ]
To determine the feasibility of dual modality therapy described as cytotoxic therapy followed by radiation therapy for the management of MMMTs.
Complete list of historical versions of study NCT00476086 on ClinicalTrials.gov Archive Site
  • 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 ]
To describe (1) the response rate by RECIST criteria per stage (2) time to progression (3) the safety profile of dual modality treatment.
Not Provided
Not Provided
 
Oxaliplatin and Gemcitabine Followed by Radiation Therapy in the Management of Mixed Mullerian Tumors of the Uterus
A Phase II Study of Oxaliplatin and Gemcitabine Followed by Radiation Therapy in the Management of Mixed Mullerian Tumors of the Uterus

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.

  • 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.
Interventional
Phase 2
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Mixed Mullerian Tumors of the Uterus
  • 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
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
24
September 2013
September 2013   (final data collection date for primary outcome measure)

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
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00476086
06-063
Yes
Susana M. Campos, MD, Dana-Farber Cancer Institute
Dana-Farber Cancer Institute
  • Sanofi
  • Brigham and Women's Hospital
  • Massachusetts General Hospital
Principal Investigator: Susana Campos, MD Dana-Farber Cancer Institute
Dana-Farber Cancer Institute
August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP