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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Gynecologic Oncology Group
ClinicalTrials.gov Identifier:
NCT00101127
First received: January 7, 2005
Last updated: February 12, 2014
Last verified: February 2014
  Purpose

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.


Condition Intervention Phase
Sarcoma
Biological: filgrastim
Biological: pegfilgrastim
Drug: docetaxel
Drug: gemcitabine hydrochloride
Phase 2

Study Type: Interventional
Study Design: Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Gynecologic Oncology Group:

Primary Outcome Measures:
  • Antitumor activity [ Designated as safety issue: No ]
  • Toxicity [ Designated as safety issue: Yes ]

Study Start Date: December 2003
Primary Completion Date: July 2006 (Final data collection date for primary outcome measure)
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.

PROJECTED ACCRUAL: A total of 12-43 patients will be accrued for this study within 12-28 months.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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:

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00101127

  Show 60 Study Locations
Sponsors and Collaborators
Gynecologic Oncology Group
Investigators
Study Chair: Martee L. Hensley, MD Memorial Sloan-Kettering Cancer Center
Investigator: Gregory P. Sutton, MD St. Vincent Gynecologic Oncology at St. Vincent Oncology Center
  More Information

Additional Information:
Publications:
Responsible Party: Gynecologic Oncology Group
ClinicalTrials.gov Identifier: NCT00101127     History of Changes
Other Study ID Numbers: GOG-0087L, CDR0000405892
Study First Received: January 7, 2005
Last Updated: February 12, 2014
Health Authority: United States: Federal Government

Keywords provided by Gynecologic Oncology Group:
recurrent uterine sarcoma
stage III uterine sarcoma
stage IV uterine sarcoma
uterine leiomyosarcoma

Additional relevant MeSH terms:
Leiomyosarcoma
Sarcoma
Neoplasms, Muscle Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Gemcitabine
Docetaxel
Lenograstim
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Radiation-Sensitizing Agents
Adjuvants, Immunologic

ClinicalTrials.gov processed this record on July 22, 2014