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Combination Chemotherapy in Treating Patients With Advanced Cancer

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ClinicalTrials.gov Identifier: NCT00003707
Recruitment Status : Completed
First Posted : July 15, 2003
Last Update Posted : June 28, 2012
National Cancer Institute (NCI)
Information provided by (Responsible Party):
The University of Texas Health Science Center at San Antonio

Brief Summary:

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 or disease Intervention/treatment Phase
Unspecified Adult Solid Tumor, Protocol Specific Drug: gemcitabine hydrochloride Drug: tipifarnib Phase 1

Detailed Description:


  • Determine the maximum tolerated dose and dose limiting toxicities of tipifarnib in combination with gemcitabine in patients with advanced cancer.
  • Investigate potential pharmacokinetic interactions between tipifarnib and gemcitabine in these patients.
  • Determine the efficacy of this regimen in patients with measurable or evaluable disease.
  • Evaluate the quality of life of these patients.

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 22 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: 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
Study Start Date : October 1998
Primary Completion Date : November 2002
Study Completion Date : November 2002

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Pathologically proven advanced cancer for which no curative therapy exists



  • 18 and over

Performance status:

  • ECOG 0-2

Life expectancy:

  • Not specified


  • Absolute neutrophil count greater than 1,500/mm^3
  • Platelet count greater than 100,000/mm^3
  • Hemoglobin greater than 9 g/dL


  • Bilirubin normal
  • SGOT and SGPT no greater than 2 times upper limit of normal (ULN) (no greater than 5 times ULN if liver metastases present)


  • Creatinine normal


  • Unassisted oral or enteral intake sufficient to maintain a reasonable state of nutrition
  • No concurrent medical condition that is likely to interfere with study participation
  • No active visual disturbances that require intervention beyond corrective lenses
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception


Biologic therapy:

  • No prior bone marrow transplantation
  • No concurrent immunotherapy


  • At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin)
  • No prior high dose chemotherapy with bone marrow or stem cell rescue
  • No other concurrent chemotherapy

Endocrine therapy:

  • No concurrent hormone therapy (except megestrol acetate)


  • At least 4 weeks since prior radiotherapy
  • No prior radiotherapy to 25% or more of bone marrow
  • No concurrent radiotherapy (except palliative radiotherapy within the first 28 days of the study)


  • Not specified


  • At least 30 days since prior investigational therapy
  • No concurrent investigational therapy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00003707

United States, Texas
San Antonio Cancer Institute
San Antonio, Texas, United States, 78229-3264
Sponsors and Collaborators
The University of Texas Health Science Center at San Antonio
National Cancer Institute (NCI)
Study Chair: Eric K. Rowinsky, MD San Antonio Cancer Institute

Responsible Party: The University of Texas Health Science Center at San Antonio
ClinicalTrials.gov Identifier: NCT00003707     History of Changes
Other Study ID Numbers: CDR0000066815
P30CA054174 ( U.S. NIH Grant/Contract )
UTHSC-9785011335 ( Other Identifier: UTHSCSA IRB )
JRF-R115777-USA-4A ( Other Identifier: Johnson and Johnson )
SACI-IDD-98-03 ( Other Identifier: San Antonio Cancer Institute )
NCI-V98-1501 ( Other Identifier: NCI )
First Posted: July 15, 2003    Key Record Dates
Last Update Posted: June 28, 2012
Last Verified: June 2012

Keywords provided by The University of Texas Health Science Center at San Antonio:
unspecified adult solid tumor, protocol specific

Additional relevant MeSH terms:
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs