Combination Chemotherapy in Treating Patients With Advanced Cancer

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
The University of Texas Health Science Center at San Antonio
ClinicalTrials.gov Identifier:
NCT00003707
First received: November 1, 1999
Last updated: June 26, 2012
Last verified: June 2012
  Purpose

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 1

Study Type: Interventional
Study Design: Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by The University of Texas Health Science Center at San Antonio:

Enrollment: 22
Study Start Date: October 1998
Study Completion Date: November 2002
Primary Completion Date: November 2002 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

  • 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.

  Eligibility

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

DISEASE CHARACTERISTICS:

  • Pathologically proven advanced cancer for which no curative therapy exists

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Performance status:

  • ECOG 0-2

Life expectancy:

  • Not specified

Hematopoietic:

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

Hepatic:

  • 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)

Renal:

  • Creatinine normal

Other:

  • 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

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • No prior bone marrow transplantation
  • No concurrent immunotherapy

Chemotherapy:

  • 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)

Radiotherapy:

  • 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)

Surgery:

  • Not specified

Other:

  • At least 30 days since prior investigational therapy
  • No concurrent investigational therapy
  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: NCT00003707

Locations
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
Investigators
Study Chair: Eric K. Rowinsky, MD San Antonio Cancer Institute
  More Information

Additional Information:
No publications provided

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, UTHSC-9785011335, JRF-R115777-USA-4A, SACI-IDD-98-03, NCI-V98-1501
Study First Received: November 1, 1999
Last Updated: June 26, 2012
Health Authority: United States: Federal Government
United States: Institutional Review Board
United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Gemcitabine
Tipifarnib
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

ClinicalTrials.gov processed this record on August 28, 2014