Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Published Results
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Treatment	Completed	18 and over	NCI	GOG-0131G NCT00031629

Objectives

1. Determine the antitumor activity of docetaxel, gemcitabine, and filgrastim (G-CSF) or pegfilgrastim in patients with persistent or recurrent uterine leiomyosarcoma.
2. Determine the nature and degree of toxicity of this regimen in these patients.

Entry Criteria

Disease Characteristics:

• 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

    OR

  • 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

Prior/Concurrent Therapy:

Biologic therapy:

• 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

Chemotherapy:

• See Disease Characteristics
• See Biologic therapy
• At least 3 weeks since prior chemotherapy and recovered
• No prior docetaxel or gemcitabine
• No other prior cytotoxic chemotherapy for recurrent or persistent disease, including retreatment with initial regimens
• No prior chemotherapy for another malignancy that would preclude study

Endocrine therapy:

• At least 1 week since prior hormonal therapy for this disease
• Concurrent hormone replacement therapy allowed

Radiotherapy:

• See Disease Characteristics
• At least 3 weeks since prior radiotherapy and recovered

Surgery:

• See Disease Characteristics
• Recovered from prior recent surgery

Other:

• At least 3 weeks since other prior therapy for this disease
• No concurrent amifostine or other protective agents

Patient Characteristics:

Age:

• 18 and over

Performance status:

• GOG 0-2

Life expectancy:

• Not specified

Hematopoietic:

• Absolute neutrophil count at least 1,500/mm³
• Platelet count at least 100,000/mm³

Hepatic:

• 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

Renal:

• Creatinine no greater than 1.5 times ULN

Other:

• 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

Expected Enrollment

A total of 19-51 patients will be accrued for this study within 10-24 months.

Outcomes

Antitumor activity
Toxicity

Outline

Patients receive gemcitabine IV over 90 minutes on days 1 and 8, docetaxel IV over 1 hour on day 8, and filgrastim (G-CSF) subcutaneously (SC) on days 9-15 or pegfilgrastim SC on day 9 only. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.

Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.

Hensley ML, Blessing JA, Degeest K, et al.: Fixed-dose rate gemcitabine plus docetaxel as second-line therapy for metastatic uterine leiomyosarcoma: a Gynecologic Oncology Group phase II study. Gynecol Oncol 109 (3): 323-8, 2008.[PUBMED Abstract]

Trial Contact Information

Trial Lead Organizations

Gynecologic Oncology Group

Martee Hensley, MD, Protocol chair		Ph: 212-639-6902; 800-525-2225

Registry Information
Official Title		A Phase II Evaluation Of Docetaxel And Gemcitabine Plus G-CSF In The Treatment Of Recurrent Or Persistent Leiomyosarcoma Of The Uterus
Trial Start Date		2002-01-14
Trial Completion Date		2009-01-25
Registered in ClinicalTrials.gov		NCT00031629
Date Submitted to PDQ		2001-12-21
Information Last Verified		2006-12-08
NCI Grant/Contract Number		CA27469

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