RATIONALE: 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.

PURPOSE: This phase I trial is studying the side effects and best dose of rebeccamycin analog and oxaliplatin in treating patients with refractory solid tumors.

Condition	Treatment or Intervention	Phase
unspecified adult solid tumor, protocol specific	Drug: oxaliplatin  Drug: rebeccamycin analogue  Procedure: chemotherapy	Phase I

Further Study Details: 

OBJECTIVES:

• Determine the maximum tolerated dose of rebeccamycin analogue given in combination with oxaliplatin in patients with refractory solid tumors.
• Determine the dose-limiting toxic effects of this regimen in these patients.
• Determine the pharmacokinetics of this regimen in these patients.

OUTLINE: This is a dose-escalation study.

Patients receive rebeccamycin analogue IV over 1 hour on days 1-5 and oxaliplatin IV over 2 hours on day 5. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Cohorts of 3-6 patients receive escalating doses of rebeccamycin analogue and oxaliplatin until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. At least 6 patients are treated at the MTD.

Patients are followed annually for survival.

PROJECTED ACCRUAL: Approximately 3-15 patients will be accrued for this study.

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed solid tumor
• Refractory disease
• Not amenable to conventional surgery, chemotherapy, or radiotherapy
• No known brain metastasis

PATIENT CHARACTERISTICS: Age

• 18 and over

Performance status

• ECOG 0-2 OR
• Karnofsky 60-100%

Life expectancy

• At least 12 weeks

Hematopoietic

• Absolute neutrophil count ≥ 1,500/mm^3
• Platelet count ≥ 100,000/mm^3
• Hemoglobin ≥ 9.0 g/dL

Hepatic

• AST < 2.5 times upper limit of normal
• Bilirubin < 1.5 mg/dL

Renal

• Creatinine < 1.5 mg/dL OR
• Creatinine clearance ≥ 60 mL/min

Cardiovascular

• No symptomatic congestive heart failure
• No unstable angina pectoris
• No cardiac arrhythmia
• No New York Heart Association class III or IV heart disease

Other

• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception
• No concurrent uncontrolled illness
• No active or ongoing infection
• No psychiatric illness or social situation that would preclude study compliance

PRIOR CONCURRENT THERAPY: Biologic therapy

• Not specified

Chemotherapy

• At least 3 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered

Endocrine therapy

• Not specified

Radiotherapy

• At least 4 weeks since prior large-field radiotherapy and recovered

Surgery

• Not specified

Other

• At least 4 weeks since prior investigational agents
• At least 3 weeks since prior anticancer therapy and recovered
• No concurrent combination antiretroviral therapy for HIV-positive patients
• No other concurrent investigational agents or therapies
• No other concurrent anticancer agents or therapies

Ohio
      Ireland Cancer Center at University Hospitals of Cleveland and Case Western Reserve University, Cleveland,  Ohio,  44106-5065,  United States; Recruiting

Study chairs or principal investigators

Afshin Dowlati, MD,  Study Chair,  Ireland Cancer Center   

Study ID Numbers:  CDR0000371910; CWRU-CASE-4Y03; CWRU-020420; NCI-5921; NCT00086983
Record last reviewed:  June 2004
Last Updated:  March 10, 2005
Record first received:  July 8, 2004
ClinicalTrials.gov Identifier:  NCT00086983
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08