NCT00025454

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started Aug 2001

Longer than P75 for phase_1

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2001

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 11, 2001

Completed
1.3 years until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
5.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2008

Completed
Last Updated

February 8, 2010

Status Verified

February 1, 2010

Enrollment Period

6.9 years

First QC Date

October 11, 2001

Last Update Submit

February 5, 2010

Conditions

Unspecified Adult Solid Tumor, Protocol Specific

Keywords

unspecified adult solid tumor, protocol specific

Interventions

tipifarnibDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (4)

City of Hope Comprehensive Cancer Center

Duarte, California, 91010-3000, United States

Location

USC/Norris Comprehensive Cancer Center and Hospital

Los Angeles, California, 90033-0804, United States

Location

City of Hope Medical Group

Pasadena, California, 91105, United States

Location

University of California Davis Cancer Center

Sacramento, California, 95817, United States

Location

Related Publications (1)

  • Lara PN Jr, Law LY, Wright JJ, Frankel P, Twardowski P, Lenz HJ, Lau DH, Kawaguchi T, Gumerlock PH, Doroshow JH, Gandara DR. Intermittent dosing of the farnesyl transferase inhibitor tipifarnib (R115777) in advanced malignant solid tumors: a phase I California Cancer Consortium Trial. Anticancer Drugs. 2005 Mar;16(3):317-21. doi: 10.1097/00001813-200503000-00011.

    PMID: 15711184RESULT

MeSH Terms

Interventions

tipifarnib

Study Officials

  • Primo N. Lara, MD

    University of California, Davis

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 11, 2001

First Posted

January 27, 2003

Study Start

August 1, 2001

Primary Completion

July 1, 2008

Study Completion

July 1, 2008

Last Updated

February 8, 2010

Record last verified: 2010-02

Locations

US(4)