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Gemcitabine, Docetaxel, and Filgrastim in Treating Patients With Recurrent or Persistent Leiomyosarcoma or Soft Tissue Sarcoma
This study is ongoing, but not recruiting participants.
First Received: December 10, 1999   Last Updated: February 6, 2009   History of Changes
Sponsors and Collaborators: Memorial Sloan-Kettering Cancer Center
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00004066
  Purpose

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Colony-stimulating factors such as filgrastim may increase the number of immune cells found in bone marrow or peripheral blood and may help a person's immune system recover from the side effects of chemotherapy.

PURPOSE: Phase II trial to study the effectiveness of combining gemcitabine, docetaxel, and filgrastim in treating patients who have recurrent or persistent leiomyosarcoma or soft tissue sarcoma that cannot be removed by surgery.


Condition Intervention Phase
Ovarian Cancer
Sarcoma
Small Intestine Cancer
Biological: filgrastim
Drug: docetaxel
Drug: gemcitabine hydrochloride
Phase II

MedlinePlus related topics: Cancer Intestinal Cancer Ovarian Cancer Soft Tissue Sarcoma
Drug Information available for: Gemcitabine Docetaxel Filgrastim Gemcitabine hydrochloride
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment
Official Title: A Phase II Trial of Gemcitabine and Docetaxel in Patients With Unresectable Leiomyosarcoma

Further study details as provided by National Cancer Institute (NCI):

Estimated Enrollment: 82
Study Start Date: June 1999
Detailed Description:

OBJECTIVES:

  • Evaluate the activity of gemcitabine plus docetaxel administered with filgrastim (G-CSF) support, in terms of disease response, in patients with recurrent or persistent unresectable leiomyosarcoma or other soft tissue sarcoma.
  • Determine the tolerability of this regimen in these patients.
  • Correlate response with tumor expression of the apoptosis-regulating proteins bax, bcl-2, and survivin in these patients.

OUTLINE: Patients are stratified according to prior radiotherapy to the pelvis (yes vs no).

Patients receive gemcitabine IV over 90 minutes on days 1 and 8 followed by docetaxel IV over 1 hour on day 8 and filgrastim (G-CSF) subcutaneously on days 9-15. Treatment repeats every 3 weeks for 6 courses in the absence of disease progression or unacceptable toxicity. Patients with a partial response may receive 2 additional courses of therapy.

Patients are followed every 3 months for 1 year or until disease progression.

PROJECTED ACCRUAL: A total of 38-82 patients (19-43 with uterine leiomyosarcoma and 19-39 with other soft tissue sarcoma) will be accrued for this study.

  Eligibility

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

DISEASE CHARACTERISTICS:

  • Histologically confirmed leiomyosarcoma (LMS) or other soft tissue sarcoma

    • No gastrointestinal stromal tumors, chondrosarcoma, Kaposi's sarcoma, Ewing's sarcoma, osteosarcoma, or mesotheliomas
  • Recurrent or progressive disease defined as an increase in the size of any existing tumor (or the development of new tumors) that is not amenable to definitive surgical therapy
  • No prior chemotherapy OR
  • Failed no more than 2 prior chemotherapy regimens for LMS of the uterus or other soft tissue sarcoma
  • Bidimensionally measurable disease by physical examination or medical imaging techniques

    • Ascites and pleural effusions are not considered measurable disease
  • No uncontrolled CNS metastases

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Performance status:

  • Karnofsky 60-100%

Life expectancy:

  • Not specified

Hematopoietic:

  • Absolute neutrophil count at least 1,500/mm^3
  • Platelet count at least 100,000/mm^3

Hepatic:

  • Bilirubin no greater than 1.5 mg/dL

Renal:

  • Creatinine no greater than 2.0 mg/dL

Other:

  • No active or uncontrolled infection
  • No other prior malignancy except non-metastatic squamous cell or basal cell skin cancer or non-invasive carcinoma in situ of the cervix
  • No history of grade 3 or 4 peripheral neuropathy
  • Not pregnant or nursing

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • Not specified

Chemotherapy:

  • See Disease Characteristics
  • At least 3 weeks since prior chemotherapy
  • No prior gemcitabine or docetaxel

Endocrine therapy:

  • Not specified

Radiotherapy:

  • At least 6 weeks since prior radiotherapy

Surgery:

  • See Disease Characteristics
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00004066

Locations
United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021
Sponsors and Collaborators
Memorial Sloan-Kettering Cancer Center
Investigators
Study Chair: Robert Maki, MD, PhD Memorial Sloan-Kettering Cancer Center
  More Information

Additional Information:
Publications:
Study ID Numbers: CDR0000067268, MSKCC-99027, NCI-G99-1576
Study First Received: December 10, 1999
Last Updated: February 6, 2009
ClinicalTrials.gov Identifier: NCT00004066     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
adult leiomyosarcoma
recurrent adult soft tissue sarcoma
small intestine leiomyosarcoma
stage IV uterine sarcoma
recurrent uterine sarcoma
uterine leiomyosarcoma
ovarian sarcoma
recurrent small intestine cancer
stage IV adult soft tissue sarcoma

Study placed in the following topic categories:
Antimetabolites
Immunologic Factors
Leiomyosarcoma
Gonadal Disorders
Gastrointestinal Diseases
Urogenital Neoplasms
Ovarian Diseases
Ileal Diseases
Docetaxel
Genital Diseases, Female
Duodenal Neoplasms
Neoplasms, Connective and Soft Tissue
Soft Tissue Sarcomas
Ileal Neoplasms
Ovarian Cancer
Gemcitabine
Duodenal Diseases
Endocrine Gland Neoplasms
Jejunal Neoplasms
Ovarian Neoplasms
Digestive System Neoplasms
Genital Neoplasms, Female
Endocrine System Diseases
Intestinal Diseases
Immunosuppressive Agents
Antiviral Agents
Intestinal Neoplasms
Recurrence
Malignant Mesenchymal Tumor
Digestive System Diseases

Additional relevant MeSH terms:
Antimetabolites
Anti-Infective Agents
Neoplasms, Muscle Tissue
Antimetabolites, Antineoplastic
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Leiomyosarcoma
Gonadal Disorders
Gastrointestinal Diseases
Physiological Effects of Drugs
Urogenital Neoplasms
Ovarian Diseases
Ileal Diseases
Docetaxel
Duodenal Neoplasms
Genital Diseases, Female
Neoplasms, Connective and Soft Tissue
Neoplasms by Site
Ileal Neoplasms
Jejunal Diseases
Therapeutic Uses
Gemcitabine
Duodenal Diseases
Endocrine Gland Neoplasms
Jejunal Neoplasms
Neoplasms by Histologic Type
Ovarian Neoplasms
Digestive System Neoplasms
Genital Neoplasms, Female

ClinicalTrials.gov processed this record on May 07, 2009