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

Primary Purpose

Mixed Mullerian Tumors of the Uterus

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Gemcitabine
Oxaliplatin
Radiation
Sponsored by
Dana-Farber Cancer Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mixed Mullerian Tumors of the Uterus focused on measuring oxaliplatin, gemcitabine, MMMT

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Dana-Farber Cancer Institute
  • Massachusetts General Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Oxaliplatin/ Gemcitabine Then Radiation

Arm Description

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.

Outcomes

Primary Outcome Measures

Chemotherapy Completion Rate
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
Disease was evaluated radiologically at baseline and every X cycles on treatment; Treatment continued if radiological exam showed no progressive disease

Full Information

First Posted
May 17, 2007
Last Updated
July 26, 2018
Sponsor
Dana-Farber Cancer Institute
Collaborators
Sanofi, Brigham and Women's Hospital, Massachusetts General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00476086
Brief Title
Oxaliplatin and Gemcitabine Followed by Radiation Therapy in the Management of Mixed Mullerian Tumors of the Uterus
Official Title
A Phase II Study of Oxaliplatin and Gemcitabine Followed by Radiation Therapy in the Management of Mixed Mullerian Tumors of the Uterus
Study Type
Interventional

2. Study Status

Record Verification Date
July 2018
Overall Recruitment Status
Completed
Study Start Date
August 2006 (undefined)
Primary Completion Date
March 2012 (Actual)
Study Completion Date
December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dana-Farber Cancer Institute
Collaborators
Sanofi, Brigham and Women's Hospital, Massachusetts General Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mixed Mullerian Tumors of the Uterus
Keywords
oxaliplatin, gemcitabine, MMMT

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Oxaliplatin/ Gemcitabine Then Radiation
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Gemcitabine
Other Intervention Name(s)
Gemzar
Intervention Type
Drug
Intervention Name(s)
Oxaliplatin
Other Intervention Name(s)
Eloxatin
Intervention Type
Radiation
Intervention Name(s)
Radiation
Primary Outcome Measure Information:
Title
Chemotherapy Completion Rate
Description
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.
Time Frame
3 cycles of chemotherapy which approximates 3 months given the 28-day cycle
Secondary Outcome Measure Information:
Title
Radiation Therapy Completion Rate
Description
Disease was evaluated radiologically at baseline and every X cycles on treatment; Treatment continued if radiological exam showed no progressive disease
Time Frame
Radiation therapy was within 4-6 weeks of last chemotherapy dose. Participants received up to 5 weeks of radiation therapy.

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Susana Campos, MD
Organizational Affiliation
Dana-Farber Cancer Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dana-Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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