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R115777 Plus Topotecan in Treating Patients With Advanced Solid Tumors

This study has been completed.

Sponsors and Collaborators: New York University School of Medicine
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00005990
  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 I

MedlinePlus related topics:   Cancer   

Drug Information available for:   Topotecan hydrochloride    Topotecan    Tipifarnib   

U.S. FDA Resources

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

Further study details as provided by National Cancer Institute (NCI):

Study Start Date:   August 2000

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

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
National Cancer Institute (NCI)

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


Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site
 

Study ID Numbers:   CDR0000067979, NYU-9932, NCI-T99-0110
First Received:   July 5, 2000
Last Updated:   July 23, 2008
ClinicalTrials.gov Identifier:   NCT00005990
Health Authority:   United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
unspecified adult solid tumor, protocol specific  

Study placed in the following topic categories:
Topotecan
Tipifarnib

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

ClinicalTrials.gov processed this record on December 03, 2008




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