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R115777 in Treating Patients With Advanced Solid Tumors
This study has been completed.
First Received: October 11, 2001   Last Updated: July 23, 2008   History of Changes
Sponsors and Collaborators: Beckman Research Institute
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00025454
  Purpose

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

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


Condition Intervention Phase
Unspecified Adult Solid Tumor, Protocol Specific
Drug: tipifarnib
Phase I

Study Type: Interventional
Study Design: Treatment
Official Title: Phase I Trial of R115777 (NSA 702818) in Advanced Malignant Solid Tumors

Resource links provided by NLM:


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

Study Start Date: August 2001
Detailed Description:

OBJECTIVES:

  • Determine the maximum tolerated dose of R115777 in patients with advanced malignant solid tumors.
  • Assess the toxicity of this drug in these patients.
  • Determine, preliminarily, the efficacy of this drug in these patients.
  • Determine the potential predictors of response in patients treated with drug.

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

Patients receive oral R115777 twice daily on weeks 1 and 3. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.

Cohorts of 3-6 patients receive escalating doses of R115777 until the maximum tolerated dose (MTD) is determined.

The MTD is defined as the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.

PROJECTED ACCRUAL: A minimum of 20 patients will be accrued for this study within 12 months.

  Eligibility

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

DISEASE CHARACTERISTICS:

  • Histologically confirmed malignant tumors deemed to be incurable or refractory to therapy

    • Advanced, recurrent, or metastatic disease
  • Previously treated with at least 1 chemotherapy regimen
  • Brain metastases allowed if asymptomatic and controlled (e.g., after prior surgical resection or radiotherapy/radiosurgery) and not on steroids or anticonvulsants

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Performance status:

  • Karnofsky 60-100%

Life expectancy:

  • Not specified

Hematopoietic:

  • WBC at least 3,500/mm3
  • Absolute granulocyte count at least 1,500/mm3
  • Platelet count at least 75,000/mm3

Hepatic:

  • Bilirubin no greater than 2.5 times upper limit of normal (ULN)
  • SGOT no greater than 2.5 times ULN

Renal:

  • Creatinine clearance at least 60 mL/min OR
  • Creatinine no greater than 1.6 mg/dL

Other:

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for 3 months after study

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • No concurrent biologic therapy

Chemotherapy:

  • See Disease Characteristics
  • At least 4 weeks since prior chemotherapy (6 weeks for mitomycin or nitrosourea)

Endocrine therapy:

  • See Disease Characteristics
  • No concurrent hormonal therapy

Radiotherapy:

  • See Disease Characteristics
  • At least 4 weeks since prior radiotherapy and recovered
  • No prior radiotherapy to a field containing a measurable target lesion unless there is evidence of progression or a new lesion is present
  • No concurrent radiotherapy to measurable lesions

Surgery:

  • See Disease Characteristics
  • At least 3 weeks since prior major surgery and recovered

Other:

  • At least 2 weeks since prior proton pump inhibitors (e.g., omeprazole)
  • Concurrent H2 blockers (e.g., cimetidine or related drugs) or antacids are allowed if there is an interval of at least 2 hours between H2 blocker/antacid intake and R115777 dosing
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00025454

Locations
United States, California
City of Hope Comprehensive Cancer Center
Duarte, California, United States, 91010-3000
City of Hope Medical Group
Pasadena, California, United States, 91105
University of California Davis Cancer Center
Sacramento, California, United States, 95817
USC/Norris Comprehensive Cancer Center and Hospital
Los Angeles, California, United States, 90033-0804
Sponsors and Collaborators
Beckman Research Institute
Investigators
Study Chair: Primo N. Lara, MD University of California, Davis
  More Information

Additional Information:
Publications:
Study ID Numbers: CDR0000068963, CHNMC-PHI-33, NCI-4751
Study First Received: October 11, 2001
Last Updated: July 23, 2008
ClinicalTrials.gov Identifier: NCT00025454     History of Changes
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:
Tipifarnib

Additional relevant MeSH terms:
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Tipifarnib

ClinicalTrials.gov processed this record on September 02, 2009