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Status:

COMPLETED

Docetaxel, Gemcitabine, and Filgrastim (G-CSF) or Pegfilgrastim in Treating Patients With Advanced, Persistent, or Recurrent Uterine Leiomyosarcoma

Lead Sponsor:

Gynecologic Oncology Group

Collaborating Sponsors:

National Cancer Institute (NCI)

Conditions:

Sarcoma

Eligibility:

FEMALE

18+ years

Phase:

PHASE2

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. Colon...

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. * Determi...

Eligibility Criteria

Inclusion

  • 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:
  • Age
  • Adult
  • Performance status
  • GOG 0-2
  • Life expectancy
  • Not specified
  • Hematopoietic
  • Absolute neutrophil count ≥ 1,500/mm\^3
  • Platelet count ≥ 100,000/mm\^3
  • Hepatic
  • Bilirubin ≤ 1.5 times upper limit of normal (ULN)
  • AST ≤ 2.5 times ULN
  • Alkaline phosphatase ≤ 2.5 times ULN
  • Renal
  • Creatinine ≤ 1.5 times ULN
  • Other
  • 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
  • Surgery
  • Recovered from prior surgery
  • Other
  • Recovered from all other prior therapy
  • No prior cancer treatment that would preclude study treatment
  • No concurrent amifostine or other protective agents

Exclusion

    Key Trial Info

    Start Date :

    December 1 2003

    Trial Type :

    INTERVENTIONAL

    End Date :

    Estimated Enrollment :

    Patients enrolled

    Trial Details

    Trial ID

    NCT00101127

    Start Date

    December 1 2003

    Last Update

    February 14 2014

    Active Locations (60)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 15 (60 locations)

    1

    Kaiser Permanente Medical Center - Los Angeles

    Los Angeles, California, United States, 90027

    2

    Jonsson Comprehensive Cancer Center at UCLA

    Los Angeles, California, United States, 90095-1781

    3

    Helen and Harry Gray Cancer Center at Hartford Hospital

    Hartford, Connecticut, United States, 06102-5037

    4

    New Britain General Hospital

    New Britain, Connecticut, United States, 06050