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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


Phase 1
18 Years
N/A
Not Enrolling
Both
Unspecified Adult Solid Tumor, Protocol Specific

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Trial Information

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


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

Eric K. Rowinsky, MD

Investigator Role:

Study Chair

Investigator Affiliation:

San Antonio Cancer Institute

Authority:

United States: Federal Government

Study ID:

CDR0000066815

NCT ID:

NCT00003707

Start Date:

October 1998

Completion Date:

November 2002

Related Keywords:

  • Unspecified Adult Solid Tumor, Protocol Specific
  • unspecified adult solid tumor, protocol specific

Name

Location

San Antonio Cancer InstituteSan Antonio, Texas  78229-3264