Suspended

A Phase I Study of XL119 (Rebeccamycin Analogue) in Combination With Oxaliplatin in Patients With Refractory Solid Tumors

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What is being tested

becatecarin

+ oxaliplatin

+ pharmacological study

DrugOther
Who is being recruted

Neoplasms

Over 18 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 1
Interventional
Study Start: May 2004
See protocol details

Summary

Principal SponsorNational Cancer Institute (NCI)
Last updated: January 14, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: May 1, 2004

Actual date on which the first participant was enrolled.

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.

Official TitleA Phase I Study of XL119 (Rebeccamycin Analogue) in Combination With Oxaliplatin in Patients With Refractory Solid Tumors 
NCT00086983
Principal SponsorNational Cancer Institute (NCI)
Last updated: January 14, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

15 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Neoplasms

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

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
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.

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Case Western Reserve University

Cleveland, United StatesSee the location
SuspendedOne Study Center