Rebeccamycin Analog and Oxaliplatin in Treating Patients With Refractory Solid Tumors

NCT ID: NCT00086983

Last Updated: 2013-01-10

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-05-31

Brief 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

Detailed Description

PRIMARY OBJECTIVES:

I. To determine the maximum tolerated dose of XL119 given in conjunction with oxaliplatin.

II.To determine the dose limiting toxicities of this combination. III. To determine the pharmacokinetics of these 2 agents when given in combination.

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.

Conditions

Unspecified Adult Solid Tumor, Protocol Specific

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment (becatacarin, oxaliplatin)

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.

Group Type: EXPERIMENTAL

becatecarin

Intervention Type: DRUG

Given IV

oxaliplatin

Intervention Type: DRUG

Given IV

pharmacological study

Intervention Type: OTHER

Correlative studies

Interventions

becatecarin

Given IV

Intervention Type: DRUG

oxaliplatin

Given IV

Intervention Type: DRUG

pharmacological study

Correlative studies

Intervention Type: OTHER

Other Intervention Names

BMS-181176; rebeccamycin analogue; rebeccamycin analogue, tartrate salt; XL119; 1-OHP; Dacotin; Dacplat; Eloxatin; L-OHP; pharmacological studies

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Afshin Dowlati

Role: PRINCIPAL_INVESTIGATOR

Case Western Reserve University

Locations

Case Western Reserve University

Cleveland, Ohio, United States

Countries

United States

Other Identifiers

CASE 4Y03

Identifier Type: -

Identifier Source: secondary_id

U01CA062502

Identifier Type: NIH

Identifier Source: secondary_id

View Link

NCI-2012-03118

Identifier Type: -

Identifier Source: org_study_id