R115777 Plus Topotecan in Treating Patients With Advanced Solid Tumors

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
New York University School of Medicine
ClinicalTrials.gov Identifier:
NCT00005990
First received: July 5, 2000
Last updated: November 8, 2012
Last verified: January 2006
  Purpose

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 Intervention Phase
Unspecified Adult Solid Tumor, Protocol Specific
Drug: tipifarnib
Drug: topotecan hydrochloride
Phase 1

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: Phase I and Pharmacokinetic Study of the Farnesyl Transferase Inhibitor, R115777, in Combination With Topotecan

Resource links provided by NLM:


Further study details as provided by New York University School of Medicine:

Study Start Date: August 2000
Primary Completion Date: September 2006 (Final data collection date for primary outcome measure)
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  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: NCT00005990

Locations
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
Investigators
Study Chair: Howard S. Hochster, MD New York University School of Medicine
  More Information

Additional Information:
No publications provided

Responsible Party: New York University School of Medicine
ClinicalTrials.gov Identifier: NCT00005990     History of Changes
Other Study ID Numbers: CDR0000067979, NYU-9932, NCI-T99-0110
Study First Received: July 5, 2000
Last Updated: November 8, 2012
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Topotecan
Tipifarnib
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 23, 2014