Gemcitabine and Docetaxel in Treating Patients With Recurrent or Persistent Uterine Cancer

Completed · Phase 2

Conditions studied: Recurrent Uterine Corpus Sarcoma, Uterine Carcinosarcoma

In brief

This phase II trial is studying how well giving gemcitabine together with docetaxel works in treating patients with recurrent or persistent uterine cancer. Drugs used in chemotherapy, such as gemcitabine and docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.

Key facts

Study ID

NCT00114218

Run by

Gynecologic Oncology Group

People needed

28

Starts

2005-03-01

Last updated by the study team

2019-01-08

Who can join

Age: any. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Histologically confirmed uterine carcinosarcoma
• Malignant mixed Müllerian tumor, homologous or heterologous type
• Recurrent or persistent disease
• Progressive disease after prior local therapy
• Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR ≥ 10 mm by spiral CT scan
• At least 1 target lesion
• Tumors within a previously irradiated field are not considered target lesions except documented progression or biopsy to confirm persistence at least 90 days after completion of radiation therapy
• Received 1, and only 1, prior chemotherapy regimen for carcinosarcoma
• Initial treatment may have included high-dose therapy, consolidation, or extended therapy administered after surgical or non-surgical assessment
• Ineligible for higher priority GOG protocol (i.e., any active phase III GOG protocol for the same patient population)
• Performance status - GOG 0-2
• Absolute neutrophil count ≥ 1,500/mm\^3
• Platelet count ≥ 100,000/mm\^3
• Bilirubin ≤ 1.5 times upper limit normal (ULN)
• SGOT ≤ 2.5 times ULN
• Alkaline phosphatase ≤ 2.5 times ULN
• Creatinine ≤ 1.5 times ULN
• No severe pulmonary disease requiring oxygen supplementation
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception
• No active infection requiring antibiotics
• No other invasive malignancy within the past 5 years except nonmelanoma skin cancer
• No neuropathy (sensory or motor) > grade 1
• At least 3 weeks since prior biologic therapy or immunotherapy for the malignancy

Where it is running

• Gynecologic Oncology Group — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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