Know Cancer

or
forgot password

Phase I and Pharmacokinetic Study of the Farnesyl Transferase Inhibitor, R115777, in Combination With Topotecan


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

Thank you

Trial Information

Phase I and Pharmacokinetic Study of the Farnesyl Transferase Inhibitor, R115777, in Combination With Topotecan


OBJECTIVES:

- Determine the dose-limiting toxic effects of R115777 and topotecan in patients with
advanced solid tumors.

- Determine the maximum tolerated dose of this regimen in these patients.

- Determine pharmacokinetic profiles of topotecan alone and in combination with R115777
in these patients.

- Measure the inhibition of ras-farnesylation and topo-1 inhibition in peripheral blood
mononuclear cells in these patients when treated with this regimen.

- Determine activity of this treatment in these patients.

OUTLINE: This is a dose-escalation, multicenter study.

Patients receive oral R115777 twice daily on days 2-21 (in the first course only R115777
begins on day 3) and topotecan IV continuously on days 1-21. Treatment continues every 28
days in the absence of disease progression or unacceptable toxicity.

Cohorts of 3-6 patients receive escalating doses of R115777 and topotecan until the maximum
tolerated dose (MTD) is determined. The MTD is defined as the dose at which 2 of 3 or 6
patients experience dose-limiting toxicity.

PROJECTED ACCRUAL: A total of 18-24 patients will be accrued for this study.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically confirmed advanced solid tumor not amenable to standard curative
therapy

PATIENT CHARACTERISTICS:

Age:

- 18 and over

Performance status:

- ECOG 0-1

Life expectancy:

- At least 6 months

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

- SGOT no greater than 5 times upper limit of normal (ULN)

- Alkaline phosphatase no greater than 5 times ULN

- No significant hepatic dysfunction that would preclude study

Renal:

- Creatinine no greater than 1.5 mg/dL OR

- Creatinine clearance at least 50 mL/min

Cardiovascular:

- No significant cardiovascular dysfunction that would preclude study

Other:

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- No malabsorption syndrome, partial or complete bowel obstruction, disease
significantly affecting gastrointestinal function, or major resection of the stomach
or proximal small bowel

- At least 1 week since prior active infection requiring systemic medical therapy

- No significant organ system dysfunction (neurologic, endocrine) that would preclude
study

- No dementia or altered mental status that would preclude study

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- Not specified

Chemotherapy:

- No more than 3 prior chemotherapy regimens

- At least 4 weeks since prior chemotherapy and recovered

Endocrine therapy:

- Not specified

Radiotherapy:

- No more than 25% of bone marrow volume irradiated

- No prior pelvic radiation

- At least 4 weeks since prior radiotherapy and recovered

Surgery:

- Not specified

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Howard S. Hochster, MD

Investigator Role:

Study Chair

Investigator Affiliation:

New York University School of Medicine

Authority:

United States: Food and Drug Administration

Study ID:

CDR0000067979

NCT ID:

NCT00005990

Start Date:

August 2000

Completion Date:

Related Keywords:

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

Name

Location

NYU Cancer Institute at New York University Medical CenterNew York, New York  10016