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

May 17, 2007
May 5, 2016
August 2006
March 2012   (final data collection date for primary outcome measure)
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.
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
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
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 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.

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.

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
    Other Name: Gemzar
  • Drug: Oxaliplatin
    Other Name: Eloxatin
  • Radiation: Radiation
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.
Interventions:
  • Drug: Gemcitabine
  • Drug: Oxaliplatin
  • Radiation: Radiation
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
December 2015
March 2012   (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   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00476086
06-063
Yes
No
Not Provided
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
May 2016

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