Know Cancer

forgot password

A Phase I Study of Oxaliplatin in Combination With Capecitabine in Metastatic/Recurrent Solid Tumors

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

Thank you

Trial Information

A Phase I Study of Oxaliplatin in Combination With Capecitabine in Metastatic/Recurrent Solid Tumors

OBJECTIVES: I. Determine the maximum tolerated dose of capecitabine when administered in
combination with oxaliplatin in patients with metastatic or recurrent solid tumors. II.
Determine the toxicities of this treatment regimen in this patient population.

OUTLINE: This is a dose escalation study of capecitabine. Patients receive oxaliplatin IV
over 2 hours on day 1 and oral capecitabine twice daily on days 1-14. Treatment repeats
every 2 weeks in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6
patients receive escalating doses of capecitabine 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 toxicity. Patients are followed for disease progression and

PROJECTED ACCRUAL: A total of 12-15 patients will be accrued for this study.

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 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)

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:

August 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