Overview

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

Status:
Completed
Trial end date:
1969-12-31
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
City of Hope Medical Center
Collaborator:
National Cancer Institute (NCI)
Treatments:
Docetaxel
Oxaliplatin
Criteria
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)