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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
N/A
Not Enrolling
Both
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


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.


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:

Interventional

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:

Yes

Principal Investigator

Afshin Dowlati

Investigator Role:

Principal Investigator

Investigator Affiliation:

Case Western Reserve University

Authority:

United States: Food and Drug Administration

Study ID:

NCI-2012-03118

NCT ID:

NCT00086983

Start Date:

May 2004

Completion Date:

Related Keywords:

  • Unspecified Adult Solid Tumor, Protocol Specific
  • Neoplasms

Name

Location

Case Western Reserve UniversityCleveland, Ohio  44106