Oxaliplatin Plus Capecitabine in Treating Patients With Metastatic or Recurrent Solid Tumor

NCT00005839 | Completed Phase 1

• 5 other identifiers: CDR0000067854U01CA062505CHNMC-PHI-25CHNMC-IRB-99130NCI-T99-0005
• 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 combined with capecitabine in treating patients who have metastatic or recurrent solid tumors.

Conditions

Unspecified Adult Solid Tumor, Protocol Specific

Keywords

unspecified adult solid tumor, protocol specific

Interventions

capecitabine DRUG

oxaliplatin DRUG

Eligibility Criteria

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

DISEASE CHARACTERISTICS: Histologically or cytologically confirmed metastatic or recurrent solid tumor that has failed standard therapy or for which no standard therapy exists No known brain metastases or carcinomatosis meningitis PATIENT CHARACTERISTICS: Age: 18 and over Performance status: SWOG 0-2 Karnofsky 60-100% Life expectancy: At least 12 weeks Hematopoietic: WBC at least 3,000/mm3 Absolute neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 2 times normal AST no greater than 2.5 times normal Renal: Creatinine normal OR Creatinine clearance greater than 60 mL/min Calcium no greater than 12 mg/dL Cardiovascular: No symptomatic congestive heart failure No unstable angina pectoris No cardiac arrhythmia Other: No evidence of neuropathy No history of allergies to platinum compounds or antiemetics that would preclude study No other uncontrolled illness (e.g., ongoing or active infection) No medical, social, or psychological factors that would preclude study Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: At least 4 weeks since prior immunotherapy and recovered Chemotherapy: At least 4 weeks since prior chemotherapy (6 weeks for mitomycin and nitrosoureas) and recovered Prior fluorouracil or cisplatin allowed Endocrine therapy: Not specified Radiotherapy: At least 4 weeks since prior radiotherapy and recovered Surgery: Recovered from prior surgery Other: At least 30 days since prior investigational drugs No concurrent 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)

USC/Norris Comprehensive Cancer Center

Los Angeles, California, 90033-0800, United States

Location

Beckman Research Institute, City of Hope

Los Angeles, California, 91010, United States

Location

University of California Davis Cancer Center

Sacramento, California, 95817, United States

Location

MeSH Terms

Interventions

Capecitabine; Oxaliplatin

Intervention Hierarchy (Ancestors)

Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Coordination Complexes; Organic Chemicals

Study Officials

• Heinz-Josef Lenz, MD

  University of Southern California

  STUDY CHAIR

Study Design

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

Study Record Dates

• First Submitted: June 2, 2000
• First Posted: April 21, 2003
• Study Start: August 1, 2000
• Primary Completion: June 1, 2004
• Study Completion: June 1, 2004
• Last Updated: June 8, 2015

Record last verified: 2015-06

Locations

US (3)