A Phase II Evaluation of Docetaxel (NSC #628503) and Gemcitabine (NSC #613327) Plus G-CSF in the Treatment of Recurrent or Advanced Leiomyosarcoma of the Uterus
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Gynecologic Oncology Group
- Locations
- 60
- Primary Endpoint
- Antitumor activity
Study Overview
Brief Summary
RATIONALE: Drugs used in chemotherapy, such as docetaxel and gemcitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Colony-stimulating factors, such as G-CSF and pegfilgrastim, may increase the number of immune cells found in bone marrow or peripheral blood and may help the immune system recover from the side effects of chemotherapy. Giving docetaxel and gemcitabine together with G-CSF or pegfilgrastim may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving docetaxel and gemcitabine together with G-CSF or pegfilgrastim works in treating patients with advanced, persistent, or recurrent uterine leiomyosarcoma.
Detailed Description
OBJECTIVES:
- Determine the antitumor activity of docetaxel, gemcitabine, and filgrastim (G-CSF) or pegfilgrastim in patients with advanced, persistent, or recurrent uterine leiomyosarcoma.
- Determine the nature and degree of toxicity of this regimen in these patients.
OUTLINE: This is a multicenter study. Patients are stratified according to prior pelvic radiotherapy (yes vs no).
Patients receive gemcitabine IV over 90 minutes on days 1 and 8 and docetaxel IV over 1 hour on day 8. Patients also receive filgrastim (G-CSF) subcutaneously (SC) on days 9-15 OR pegfilgrastim SC on day 9. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Patients are followed every 3 months for 2 years and then every 6 months for 3 years.
Study Design
- Study Type
- Interventional
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed uterine leiomyosarcoma
- •Advanced, persistent, or recurrent disease
- •Documented disease progression
- •Measurable disease
- •At least 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 considered nontarget lesions
- •Ineligible for higher priority GOG protocols (i.e., any active phase III GOG protocol for the same patient population)
- •PATIENT CHARACTERISTICS:
- •Performance status
- •Life expectancy
- •Not specified
- •Hematopoietic
- •Absolute neutrophil count ≥ 1,500/mm^3
- •Platelet count ≥ 100,000/mm^3
- •Bilirubin ≤ 1.5 times upper limit of normal (ULN)
- •AST ≤ 2.5 times ULN
- •Alkaline phosphatase ≤ 2.5 times ULN
- •Creatinine ≤ 1.5 times ULN
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •No neuropathy (sensory or motor) > grade 1
- •No other invasive malignancy within the past 5 years except nonmelanoma skin cancer
- •No active infection requiring antibiotics
- •No known hypersensitivity to E. coli-derived proteins
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •Not specified
- •Chemotherapy
- •No prior cytotoxic chemotherapy for the malignancy
- •Endocrine therapy
- •At least 1 week since prior hormonal therapy for the malignancy
- •Concurrent hormone replacement therapy allowed
- •Radiotherapy
- •See Disease Characteristics
- •Recovered from prior radiotherapy
- •Recovered from prior surgery
- •Recovered from all other prior therapy
- •No prior cancer treatment that would preclude study treatment
- •No concurrent amifostine or other protective agents
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Antitumor activity
Toxicity
Secondary Outcomes
No secondary outcomes reported