Combination Chemotherapy in Treating Patients With Advanced Cancer

NCT00003707 | Completed Phase 1 DMC

• 6 other identifiers: CDR0000066815P30CA054174UTHSC-9785011335JRF-R115777-USA-4ASACI-IDD-98-03NCI-V98-1501
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells. PURPOSE: Phase I trial to study the effectiveness of combining R115777 with gemcitabine in treating patients with advanced cancer.

Conditions

Unspecified Adult Solid Tumor, Protocol Specific

Keywords

unspecified adult solid tumor, protocol specific

Interventions

gemcitabine hydrochloride DRUG

tipifarnib DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * Pathologically proven advanced cancer for which no curative therapy exists PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * ECOG 0-2 Life expectancy: * Not specified Hematopoietic: * Absolute neutrophil count greater than 1,500/mm\^3 * Platelet count greater than 100,000/mm\^3 * Hemoglobin greater than 9 g/dL Hepatic: * Bilirubin normal * SGOT and SGPT no greater than 2 times upper limit of normal (ULN) (no greater than 5 times ULN if liver metastases present) Renal: * Creatinine normal Other: * Unassisted oral or enteral intake sufficient to maintain a reasonable state of nutrition * No concurrent medical condition that is likely to interfere with study participation * No active visual disturbances that require intervention beyond corrective lenses * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: * No prior bone marrow transplantation * No concurrent immunotherapy Chemotherapy: * At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) * No prior high dose chemotherapy with bone marrow or stem cell rescue * No other concurrent chemotherapy Endocrine therapy: * No concurrent hormone therapy (except megestrol acetate) Radiotherapy: * At least 4 weeks since prior radiotherapy * No prior radiotherapy to 25% or more of bone marrow * No concurrent radiotherapy (except palliative radiotherapy within the first 28 days of the study) Surgery: * Not specified Other: * At least 30 days since prior investigational therapy * No concurrent investigational therapy

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

Sponsors & Collaborators

• The University of Texas Health Science Center at San Antonio: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

San Antonio Cancer Institute

San Antonio, Texas, 78229-3264, United States

Location

MeSH Terms

Interventions

Gemcitabine; tipifarnib

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring

Study Officials

• Eric K. Rowinsky, MD

  San Antonio Cancer Institute

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 1, 1999
• First Posted: July 15, 2003
• Study Start: October 1, 1998
• Primary Completion: November 1, 2002
• Study Completion: November 1, 2002
• Last Updated: June 28, 2012

Record last verified: 2012-06

Locations

US (1)