Clinical trial NCT00476086: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Mixed Mullerian Tumors of the Uterus
Keywords: oxaliplatin
gemcitabine
MMMT
Lead sponsor: Dana-Farber Cancer Institute
Sponsor class: OTHER
Collaborators: name: Sanofi
name: Brigham and Women's Hospital
name: Massachusetts General Hospital
First posted: 2007-05-21
Enrollment: 20
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Chemotherapy Completion Rate
timeFrame: 3 cycles of chemotherapy which approximates 3 months given the 28-day cycle
Secondary outcomes:
measure: Radiation Therapy Completion Rate
timeFrame: Radiation therapy was within 4-6 weeks of last chemotherapy dose. Participants received up to 5 weeks of radiation therapy.
Other outcomes:
Locations:
city: Boston
country: United States
facility: Dana-Farber Cancer Institute
state: Massachusetts
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Dana-Farber Cancer Institute
name: Susana Campos, MD
role: PRINCIPAL_INVESTIGATOR
References: