R115777 in Treating Patients With Advanced Solid Tumors

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
City of Hope Medical Center
ClinicalTrials.gov Identifier:
NCT00025454
First received: October 11, 2001
Last updated: February 5, 2010
Last verified: February 2010
  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 1

Study Type: Interventional
Study Design: Primary Purpose: 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 City of Hope Medical Center:

Study Start Date: August 2001
Study Completion Date: July 2008
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
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
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: NCT00025454

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

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00025454     History of Changes
Other Study ID Numbers: CDR0000068963, U01CA062505, P30CA033572, CHNMC-PHI-33, NCI-4751
Study First Received: October 11, 2001
Last Updated: February 5, 2010
Health Authority: United States: Federal Government

Keywords provided by City of Hope Medical Center:
unspecified adult solid tumor, protocol specific

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

ClinicalTrials.gov processed this record on August 26, 2014