Docetaxel and Oxaliplatin in Treating Patients With Metastatic or Recurrent Solid Tumor

NCT00004243 | Completed Phase 1

• 6 other identifiers: CDR0000067488U01CA062505CHNMC-PHASEI-24CHNMC-IRB-99081LAC-USC-OC-99-2NCI-T99-0004
• 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 docetaxel and oxaliplatin in treating patients who have metastatic or recurrent solid tumor.

Conditions

Unspecified Adult Solid Tumor, Protocol Specific

Keywords

unspecified adult solid tumor, protocol specific

Interventions

docetaxel 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 OR 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 1.5 times upper limit of normal (ULN) AST/ALT no greater than 2.5 times ULN Renal: Creatinine no greater than 1.25 times ULN Calcium no greater than 12 mg/dL Cardiovascular: No symptomatic congestive heart failure No unstable angina pectoris No cardiac arrhythmia Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No evidence of neuropathy No history of allergy to platinum compounds No history of allergy to antiemetics appropriate for administration in conjunction with protocol directed chemotherapy No uncontrolled concurrent illness (e.g., ongoing or active infection) No medical, social, or psychological factors that would preclude consent and follow up PRIOR CONCURRENT THERAPY: Biologic therapy: At least 4 weeks since prior immunotherapy and recovered Chemotherapy: Prior chemotherapy, including fluorouracil and cisplatin, allowed At least 4 weeks since prior chemotherapy (6 weeks for mitomycin and nitrosoureas) and recovered 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 other prior investigational drugs No other concurrent investigational or commercial agents or therapies 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

Docetaxel; Oxaliplatin

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Coordination Complexes

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: January 28, 2000
• First Posted: April 18, 2003
• Study Start: March 1, 2000
• Last Updated: January 13, 2010

Record last verified: 2010-01

Locations

US (3)