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A Phase II Trial of Gemcitabine and Docetaxel in Patients With Unresectable Leiomyosarcoma


Phase 2
18 Years
N/A
Not Enrolling
Both
Ovarian Cancer, Sarcoma, Small Intestine Cancer

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Trial Information

A Phase II Trial of Gemcitabine and Docetaxel in Patients With Unresectable Leiomyosarcoma


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Robert Maki, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center

Authority:

United States: Federal Government

Study ID:

99-027

NCT ID:

NCT00004066

Start Date:

June 1999

Completion Date:

October 2003

Related Keywords:

  • Ovarian Cancer
  • Sarcoma
  • Small Intestine Cancer
  • 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
  • Leiomyosarcoma
  • Ovarian Neoplasms
  • Duodenal Neoplasms
  • Ileal Neoplasms
  • Jejunal Neoplasms
  • Intestinal Neoplasms
  • Sarcoma

Name

Location

Memorial Sloan-Kettering Cancer CenterNew York, New York  10021