PHASE I TRIAL OF IRINOTECAN AND TOMUDEX IN COMBINATION ON AN EVERY THREE WEEK SCHEDULE
18 Years
N/A
Both
Unspecified Adult Solid Tumor, Protocol Specific
Trial Information
PHASE I TRIAL OF IRINOTECAN AND TOMUDEX IN COMBINATION ON AN EVERY THREE WEEK SCHEDULE
OBJECTIVES: I. Determine the maximum tolerated dose of ICI D1694 (TDX) when given with
irinotecan (CPT-11) every 3 weeks in patients with advanced solid malignancies. II. Describe
the pharmacokinetics of TDX and CPT-11 when given in combination. III. Investigate the
relationship between topoisomerase I expression in peripheral mononuclear cells and
myelosuppression and/or gastrointestinal toxicity. IV. Investigate the effect of CPT-11 on
thymidylate synthase expression in tumor.
OUTLINE: This is a dose-escalating study to determine the maximum tolerated dose (MTD) of
ICI D1694 (TDX) given in combination with irinotecan. Irinotecan is given intravenously on
day 1 and ICI D1694 intravenously on day 2. Treatment is repeated every 3 weeks until
disease progression or unacceptable toxicity intervenes. Cohorts of 3-6 patients receive
escalated doses of TDX until the MTD is defined; an additional 10-12 patients will be
entered at the MTD to confirm this as a recommended phase II dose.
PROJECTED ACCRUAL: 30-35 patients will be entered.
Inclusion Criteria
DISEASE CHARACTERISTICS: Histologically confirmed solid tumor for which no effective
therapy exists Measurable or evaluable disease
PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0 or 1 Hematopoietic:
WBC at least 3,000 AGC at least 1,500 Platelets at least 100,000 Hepatic: Bilirubin no
greater than 1.5 mg/dL AST/ALT no greater than 5 times normal Renal: Creatinine no greater
than 1.5 mg/dL Metabolic: Glucose no greater than 200 mg/dL Electrolytes within 10% normal
Other: No active infection that contraindicates entry No significant medical problem that
contraindicates entry Effective contraception required of fertile patients Able and
willing to participate in pharmacokinetic sampling
PRIOR CONCURRENT THERAPY: At least 3 weeks since chemotherapy (6 weeks since mitomycin or
nitrosoureas) and recovered At least 3 weeks since radiotherapy and recovered
Type of Study:
Interventional
Study Design:
Primary Purpose: Treatment
Principal Investigator
Peter J. O'Dwyer, MD, BCh
Investigator Role:
Study Chair
Investigator Affiliation:
Abramson Cancer Center of the University of Pennsylvania
Authority:
United States: Federal Government
Study ID:
CDR0000065242
NCT ID:
NCT00002902
Start Date:
April 1997
Completion Date:
Related Keywords:
- Unspecified Adult Solid Tumor, Protocol Specific
- unspecified adult solid tumor, protocol specific
- Neoplasms
Name | Location |
|---|---|
| University of Pennsylvania Cancer Center | Philadelphia, Pennsylvania 19104 |
