Combination Chemotherapy and Filgrastim or Pegfilgrastim in Treating Patients With Recurrent or Persistent Cancer of the Uterus

Completed · Phase 2

Conditions studied: Recurrent Uterine Corpus Sarcoma, Uterine Corpus Leiomyosarcoma

In brief

Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. Colony-stimulating factors such as filgrastim or pegfilgrastim may increase the number of immune cells found in bone marrow or peripheral blood and may help a person's immune system recover from the side effects of chemotherapy. This phase II trial is studying how well combination chemotherapy plus filgrastim or pegfilgrastim works in treating patients with recurrent or persistent cancer of the uterus.

Key facts

Study ID

NCT00031629

Run by

Gynecologic Oncology Group

People needed

51

Starts

2005-01-01

Last updated by the study team

2016-12-08

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Histologically confirmed uterine leiomyosarcoma
• Recurrent or persistent disease that is refractory to curative therapy or established treatments
• Must have received 1 prior chemotherapy regimen that may include high-dose therapy, consolidation, or extended therapy after surgical or nonsurgical assessment
• At least 1 unidimensionally measurable lesion
• At least 20 mm by conventional techniques
• At least 10 mm by spiral CT scan
• Lesions within a previously irradiated field allowed provided progression is documented or biopsy is obtained to confirm persistence at least 90 days following completion of radiation therapy
• Ineligible for a high priority GOG protocol
• Performance status - GOG 0-2
• Absolute neutrophil count at least 1,500/mm\^3
• Platelet count at least 100,000/mm\^3
• Bilirubin no greater than 1.1 times upper limit of normal (ULN)
• SGOT no greater than 2.5 times ULN
• Alkaline phosphatase no greater than 2.5 times ULN
• Creatinine no greater than 1.5 times ULN
• No active infection requiring antibiotics
• No motor or sensory neuropathy greater than grade 1
• No other malignancy within the past 5 years except nonmelanoma skin cancer
• Not pregnant
• Negative pregnancy test
• Fertile patients must use effective contraception
• No more than 1 prior non-cytotoxic (biologic or cytostatic) regimen (e.g., monoclonal antibodies, cytokines, or small-molecule signal transduction inhibitors) for recurrent or persistent disease
• At least 3 weeks since prior biologic or immunologic therapy for this disease
• See Disease Characteristics
• See Biologic therapy

Where it is running

• Gynecologic Oncology Group — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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