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A Phase I Study of Oxaliplatin in Combination With Docetaxel (Taxotere) Metastatic/Recurrent Solid Tumors

Phase 1
18 Years
Not Enrolling
Unspecified Adult Solid Tumor, Protocol Specific

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Trial Information

A Phase I Study of Oxaliplatin in Combination With Docetaxel (Taxotere) Metastatic/Recurrent Solid Tumors

OBJECTIVES: I. Determine the maximum tolerated dose of docetaxel when followed by
oxaliplatin in patients with metastatic or recurrent solid tumors. II. Describe the
toxicities of this regimen in this patient population at each dose level studied. III.
Evaluate the pharmacokinetics and pharmacodynamics of this regimen in these patients.

OUTLINE: This is a dose escalation study of docetaxel. Patients receive docetaxel IV over 1
hour followed by oxaliplatin IV over 2 hours on day 1 every 3 weeks. Treatment continues in
the absence of unacceptable toxicity or disease progression. Cohorts of 3-6 patients receive
escalating doses of docetaxel until the maximum tolerated dose (MTD) is determined. The MTD
is defined as the dose preceding that at which 2 of 6 patients experience dose limiting
toxicities. Patients are followed for disease progression.

PROJECTED ACCRUAL: A total of 15-20 patients will be accrued for this study within 2 years.

Inclusion 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)

Type of Study:


Study Design:

Primary Purpose: Treatment

Principal Investigator

Heinz-Josef Lenz, MD

Investigator Role:

Study Chair

Investigator Affiliation:

USC/Norris Comprehensive Cancer Center


United States: Federal Government

Study ID:




Start Date:

March 2000

Completion Date:

Related Keywords:

  • Unspecified Adult Solid Tumor, Protocol Specific
  • unspecified adult solid tumor, protocol specific
  • Neoplasms



USC/Norris Comprehensive Cancer Center Los Angeles, California  90033-0800
Beckman Research Institute, City of Hope Los Angeles, California  91010
University of California Davis Cancer Center Sacramento, California  95817