Oxaliplatin and Gemcitabine Followed by Radiation Therapy in the Management of Mixed Mullerian Tumors of the Uterus - Full Text View

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:

MedlinePlus related topics: Cancer Uterine Cancer

Drug Information available for: Oxaliplatin Gemcitabine Gemcitabine hydrochloride

U.S. FDA Resources

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:	August 2013
Estimated Primary Completion Date:	August 2013 (Final data collection date for primary outcome measure)

Intervention Details:

Given intravenously on the first and third week of each 4 week cycle

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

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:	November 30, 2012
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 May 23, 2013