Combination Chemotherapy in Treating Patients With Advanced Cancer That is Metastatic or Cannot Be Removed By Surgery

Completed · Phase 1

Conditions studied: Unspecified Adult Solid Tumor, Protocol Specific

In brief

This phase I trial studies the side effects and best dose of capecitabine when given together with oxaliplatin, leucovorin calcium, and fluorouracil in treating patients with advanced cancer that is metastatic or cannot be removed by surgery. 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.

Key facts

Study ID

NCT00043121

Run by

National Cancer Institute (NCI)

People needed

50

Starts

2002-06-01

Last updated by the study team

2013-12-11

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients must have histologically or cytologically confirmed malignancy which is metastatic or unresectable and for which standard curative or palliative measures do not exist or are no longer effective
• There is no limit on prior therapies
• ECOG performance status 0-2
• Leukocytes >= 3,000/ul
• Absolute neutrophil count >= 1,500/ul
• Platelets >= 100,000/ul
• Total bilirubin =< 1.5 mg/dL
• AST (SGOT)/ALT (SGPT) =< 2.5 x institutional upper limit of normal
• Creatinine clearance >= 50 mL/min as calculated by the Cockroft-Gault formula
• Patients with no >= grade 2 (Common Toxicity Criteria [CTC] 2.0) neuropathy
• Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control) prior to study entry and for the duration of study participation; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately
• Breastfeeding should be discontinued if the mother is treated with oxaliplatin
• Ability to understand and the willingness to sign a written informed consent document

You may not qualify if…

• Patients who have had chemotherapy or radiotherapy within 4 weeks prior to entering the study
• Patients undergoing therapy with other investigational agents
• Patients with known brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other toxicities
• History of allergy to platinum compounds or to antiemetics appropriate for administration in conjunction with protocol-directed chemotherapy
• Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, or unstable angina pectoris, or cardiac arrhythmia
• Pregnant and nursing women are excluded from this study because oxaliplatin is a DNA alkylating agent with the potential for teratogenic or abortifacient effects
• Human immunodeficiency virus (HIV)-positive patients receiving anti-retroviral therapy (HAART) are excluded from the study

Where it is running

• University of Wisconsin Hospital and Clinics — Madison, Wisconsin, United States

Full record on ClinicalTrials.gov

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