Oxaliplatin and Gemcitabine in Treating Patients With Advanced Cancer

NCT00004220 | Completed Phase 1

• 5 other identifiers: CDR0000067461P30CA033572CHNMC-PHI-23CHNMC-PHL-23NCI-T99-0003
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 3

Brief Summary

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

Conditions

Unspecified Adult Solid Tumor, Protocol Specific

Keywords

unspecified adult solid tumor, protocol specific

Interventions

gemcitabine hydrochloride DRUG

oxaliplatin DRUG

Eligibility Criteria

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

DISEASE CHARACTERISTICS: Histologically proven metastatic or unresectable malignancy for which standard therapy does not exist or is no longer effective No greater than 3 prior treatment regimens No known brain metastases PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 60-100% Life expectancy: At least 2 months Hematopoietic: WBC at least 3000/mm3 Absolute neutrophil count at least 1500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin normal SGOT/SGPT no greater than 2.5 times upper limit of normal Renal: Creatinine normal OR Creatinine clearance at least 60 mL/min Cardiovascular: No symptomatic congestive heart failure No unstable angina pectoris No cardiac arrhythmia Other: No clinically significant neuropathy Not pregnant or nursing Fertile patients must use effective contraception No allergy to platinum compounds or antiemetics No uncontrolled active infection or other illness PRIOR CONCURRENT THERAPY: Biologic therapy: See Disease Characteristics Chemotherapy: See Disease Characteristics At least 4 weeks since prior chemotherapy Endocrine therapy: See Disease Characteristics Radiotherapy: See Disease Characteristics No prior radiotherapy to at least 30% of bone marrow At least 4 weeks since prior radiotherapy Surgery: See Disease Characteristics Other: No other concurrent investigational agents No other concurrent anticancer therapy No HIV positive patients receiving antiretroviral therapy (HAART)

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

Sponsors & Collaborators

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

Study Sites (3)

Cancer Center and Beckman Research Institute, City of Hope

Duarte, California, 91010-3000, United States

Location

USC/Norris Comprehensive Cancer Center and Hospital

Los Angeles, California, 90033-0804, United States

Location

University of California Davis Cancer Center

Sacramento, California, 95817, United States

Location

MeSH Terms

Interventions

Gemcitabine; Oxaliplatin

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Coordination Complexes; Organic Chemicals

Study Officials

• Stephen I. Shibata, MD

  City of Hope Comprehensive Cancer Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 28, 2000
• First Posted: April 21, 2003
• Study Start: October 1, 1999
• Last Updated: January 13, 2010

Record last verified: 2010-01

Locations

US (3)