R115777 Plus Topotecan in Treating Patients With Advanced Solid Tumors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00005990
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : November 9, 2012
National Cancer Institute (NCI)
Information provided by (Responsible Party):
New York University School of Medicine

Brief Summary:

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.

PURPOSE: Phase I trial to study the effectiveness of R115777 plus topotecan in treating patients who have advanced solid tumors.

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

Detailed Description:


  • 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.

Study Type : Interventional  (Clinical Trial)
Primary Purpose: Treatment
Official Title: Phase I and Pharmacokinetic Study of the Farnesyl Transferase Inhibitor, R115777, in Combination With Topotecan
Study Start Date : August 2000
Actual Primary Completion Date : September 2006

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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


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



  • 18 and over

Performance status:

  • ECOG 0-1

Life expectancy:

  • At least 6 months


  • Absolute neutrophil count at least 1,500/mm^3
  • Platelet count at least 100,000/mm^3


  • 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


  • Creatinine no greater than 1.5 mg/dL OR
  • Creatinine clearance at least 50 mL/min


  • No significant cardiovascular dysfunction that would preclude study


  • 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


Biologic therapy:

  • Not specified


  • No more than 3 prior chemotherapy regimens
  • At least 4 weeks since prior chemotherapy and recovered

Endocrine therapy:

  • Not specified


  • No more than 25% of bone marrow volume irradiated
  • No prior pelvic radiation
  • At least 4 weeks since prior radiotherapy and recovered


  • Not specified

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 identifier (NCT number): NCT00005990

United States, New York
NYU Cancer Institute at New York University Medical Center
New York, New York, United States, 10016
Sponsors and Collaborators
New York University School of Medicine
National Cancer Institute (NCI)
Study Chair: Howard S. Hochster, MD New York University School of Medicine

Responsible Party: New York University School of Medicine Identifier: NCT00005990     History of Changes
Other Study ID Numbers: CDR0000067979
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: November 9, 2012
Last Verified: January 2006

Keywords provided by New York University School of Medicine:
unspecified adult solid tumor, protocol specific

Additional relevant MeSH terms:
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents