Clincosm LogoSign in Get a demo

R115777 in Treating Patients With Advanced Solid Tumors

Sponsor
City of Hope Medical Center (Other)
Overall Status
Completed
CT.gov ID
NCT00025454
Collaborator
National Cancer Institute (NCI) (NIH)
4
Locations
83
Duration (Months)

Study Details

Study Description

Brief Summary

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 or Disease Intervention/Treatment Phase
Phase 1

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.

Study Design

Study Type:
Interventional
Primary Purpose:
Treatment
Official Title:
Phase I Trial of R115777 (NSA 702818) in Advanced Malignant Solid Tumors
Study Start Date :
Aug 1, 2001
Actual Primary Completion Date :
Jul 1, 2008
Actual Study Completion Date :
Jul 1, 2008

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 City of Hope Comprehensive Cancer Center Duarte California United States 91010-3000
    2 USC/Norris Comprehensive Cancer Center and Hospital Los Angeles California United States 90033-0804
    3 City of Hope Medical Group Pasadena California United States 91105
    4 University of California Davis Cancer Center Sacramento California United States 95817

    Sponsors and Collaborators

    • City of Hope Medical Center
    • National Cancer Institute (NCI)

    Investigators

    • Study Chair: Primo N. Lara, MD, University of California, Davis

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00025454
    Other Study ID Numbers:
    • CDR0000068963
    • U01CA062505
    • P30CA033572
    • CHNMC-PHI-33
    • NCI-4751
    First Posted:
    Jan 27, 2003
    Last Update Posted:
    Feb 8, 2010
    Last Verified:
    Feb 1, 2010
    Keywords provided by , ,
    unspecified adult solid tumor, protocol specific
    Additional relevant MeSH terms:
    Neoplasms
    Tipifarnib

    Study Results

    No Results Posted as of Feb 8, 2010