Rebeccamycin Analog and Oxaliplatin in Treating Patients With Refractory Solid Tumors

• Status: Terminated
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

This phase I trial is studying the side effects and best dose of rebeccamycin analog and oxaliplatin in treating patients with refractory solid tumors. Drugs used in chemotherapy, such as rebeccamycin analog and oxaliplatin, work in different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Cancer Institute (NCI)
• Treatments: Oxaliplatin

Criteria

Inclusion Criteria:

• Patients must have a histologically confirmed solid tumor that is not amenable to conventional surgical, radiation therapy or chemotherapy treatment programs

• Prior chemotherapy and/or radiation are allowed; at least 4 weeks must have elapsed since prior large-field radiation therapy; patients must have been off previous anti-cancer therapy for at least 3 weeks (6 weeks for mitomycin-C and nitrosoureas); and recovered from all treatment related toxicity

• ECOG performance status =< 2 (Karnofsky >60%)

• Life expectancy of at least 12 weeks

• Absolute neutrophil count >= 1,500/ul

• Platelets >= 100,000/ul

• Hemoglobin >= 9.0 g/dl

• Total bilirubin =< 1.5 mg/dl

• AST(SGOT) < 2.5 X institutional upper limit of normal

• Creatinine < 1.5 mg/dl OR creatinine clearance >= 60 mL/min/1.73 m^2 for patients with creatinine levels above institutional normal

• Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) 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

• Ability to understand and the willingness to sign a written informed consent document

• All patients should have a central line placed for XL119 administration

Exclusion Criteria:

• Patients may not be receiving any other investigational agents or have received other investigational agents for at least 4 weeks

• Patients with known brain metastases should be excluded from this clinical trial

• Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements

• Pregnant and lactating women are excluded from this study

• HIV-positive patients receiving combination anti-retroviral therapy are excluded from the study

• NYHA classification III or IV heart disease