Know Cancer

or
forgot password

A Phase II Study of Oxaliplatin and Gemcitabine Followed by Radiation Therapy in the Management of Mixed Mullerian Tumors of the Uterus


Phase 2
18 Years
N/A
Open (Enrolling)
Female
Mixed Mullerian Tumors of the Uterus

Thank you

Trial Information

A Phase II Study of Oxaliplatin and Gemcitabine Followed by Radiation Therapy in the Management of Mixed 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.


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

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).

Outcome Time Frame:

2 years

Safety Issue:

No

Principal Investigator

Susana Campos, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Dana-Farber Cancer Institute

Authority:

United States: Institutional Review Board

Study ID:

06-063

NCT ID:

NCT00476086

Start Date:

August 2006

Completion Date:

August 2013

Related Keywords:

  • Mixed Mullerian Tumors of the Uterus
  • oxaliplatin
  • gemcitabine
  • MMMT
  • Uterine Neoplasms
  • Mixed Tumor, Mullerian
  • Carcinosarcoma

Name

Location

Dana-Farber Cancer InstituteBoston, Massachusetts  02115
Massachusetts General HospitalBoston, Massachusetts  02114-2617