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

Phase 1
18 Years
Not Enrolling
Unspecified Adult Solid Tumor, Protocol Specific

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Trial Information

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


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.

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

Type of Study:


Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Maximum tolerated dose defined as the highest dose tested in which none or only one patient experienced dose limiting toxicities as measured by Common Toxicity Criteria

Outcome Time Frame:

21 days

Safety Issue:


Principal Investigator

Afshin Dowlati

Investigator Role:

Principal Investigator

Investigator Affiliation:

Case Western Reserve University


United States: Food and Drug Administration

Study ID:




Start Date:

May 2004

Completion Date:

Related Keywords:

  • Unspecified Adult Solid Tumor, Protocol Specific
  • Neoplasms



Case Western Reserve University Cleveland, Ohio  44106