Know Cancer

or
forgot password

PHASE I TRIAL OF IRINOTECAN AND TOMUDEX IN COMBINATION ON AN EVERY THREE WEEK SCHEDULE


Phase 1
18 Years
N/A
Not Enrolling
Both
Unspecified Adult Solid Tumor, Protocol Specific

Thank you

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 CenterPhiladelphia, Pennsylvania  19104