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Sponsored by: |
San Antonio Cancer Institute |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00003707 |
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells.
PURPOSE: Phase I trial to study the effectiveness of combining R115777 with gemcitabine in treating patients with advanced cancer.
Condition | Intervention | Phase |
---|---|---|
Unspecified Adult Solid Tumor, Protocol Specific |
Drug: gemcitabine hydrochloride Drug: tipifarnib |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | A Phase I, Maximum Tolerated Dose (MTD) Trial to Determine the Safety and Pharmacokinetics of Chronic Oral Administration of Farnesyl Transferase Inhibitor R115777 in Combination With Gemcitabine in Subjects With Advanced Incurable Cancer |
Estimated Enrollment: | 40 |
Study Start Date: | October 1998 |
OBJECTIVES:
OUTLINE: This is a dose-escalation study of tipifarnib.
Patients receive gemcitabine IV over 30 minutes on days 1, 8, and 15 and oral tipifarnib every 12 hours beginning on day 2. Treatment continues every 4 weeks in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients each receive escalating doses of tipifarnib until the maximum tolerated dose (MTD) is reached. The MTD is defined as the dose at which fewer than one third of the patients experience dose limiting toxicity.
Quality of life is assessed before treatment, on day 22 of each course, and at the end of treatment.
PROJECTED ACCRUAL: A maximum of 40 patients will be accrued for this study.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
United States, Texas | |
San Antonio Cancer Institute | |
San Antonio, Texas, United States, 78229-3264 |
Study Chair: | Eric K. Rowinsky, MD | San Antonio Cancer Institute |
Study ID Numbers: | CDR0000066815, UTHSC-9785011335, JRF-R115777-USA-4A, SACI-IDD-98-03, NCI-V98-1501 |
Study First Received: | November 1, 1999 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00003707 |
Health Authority: | United States: Federal Government |
unspecified adult solid tumor, protocol specific |
Gemcitabine Tipifarnib |
Antimetabolites Anti-Infective Agents Antimetabolites, Antineoplastic Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Physiological Effects of Drugs |
Enzyme Inhibitors Antiviral Agents Immunosuppressive Agents Pharmacologic Actions Radiation-Sensitizing Agents Therapeutic Uses |