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Escalating Irinotecan (CPT-11) Administered 24 Hours Prior To Gemcitabine 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

Escalating Irinotecan (CPT-11) Administered 24 Hours Prior To Gemcitabine In Patients With Refractory Solid Tumors


OBJECTIVES:

- Determine the maximum tolerated dose of irinotecan when administered with gemcitabine
in patients with refractory advanced solid tumors.

- Determine the antitumor activity and toxicity of this regimen in these patients.

- Determine the pharmacokinetics and pharmacodynamics of this regimen in these patients.

- Determine the optimal dose and time interval for this regimen in these patients.

OUTLINE: This is an open-label, non-randomized, dose-escalation study of irinotecan.

Patients receive irinotecan IV over 90 minutes on days 1 and 8 and gemcitabine IV over 30
minutes on days 2 and 9. Courses repeat every 21 days in the absence of disease progression
or unacceptable toxicity.

Cohorts of 3-6 patients receive escalating doses of irinotecan until the maximum tolerated
dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6
patients experience dose-limiting toxicity.

Patients are followed every 8 weeks.

PROJECTED ACCRUAL: A total of 24 patients will be accrued for this study within 2 years.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically or cytologically confirmed advanced solid tumor that is refractory to
prior treatment

- Considered incurable with other modalities

- Measurable or evaluable disease

- The following are not considered measurable or evaluable:

- Bone metastases

- Pleural, pericardial, or peritoneal effusions

- Irradiated lesions (unless progression is documented after radiotherapy)

- Metastatic disease that has been followed using serum tumor markers allowed

- No symptomatic brain metastases

- Brain metastases may not be sole site of metastatic disease

PATIENT CHARACTERISTICS:

Age

- 18 and over

Performance status

- ECOG 0-1

Life expectancy

- At least 12 weeks

Hematopoietic

- WBC at least 3,000/mm^3

- Absolute neutrophil count at least 1,500/mm^3

- Platelet count at least 100,000/mm^3

Hepatic

- AST and ALT no greater than 1.5 times normal

- Bilirubin no greater than 1.5 mg/dL

- No clinically apparent jaundice

Renal

- Creatinine no greater than 1.6 mg/dL OR

- Creatinine clearance at least 50 mL/min

Cardiovascular

- Cardiac function normal

- No uncontrolled heart disease

- No myocardial infarction within the past 3 months

- No congestive heart failure

- No unstable or uncontrolled angina

Other

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- No other malignancy within the past 5 years except nonmelanoma skin cancer or
carcinoma in situ of the cervix

- No active infection requiring systemic therapy

- No uncontrolled seizures

- No uncontrolled diabetes mellitus

PRIOR CONCURRENT THERAPY:

Biologic therapy

- Not specified

Chemotherapy

- No prior gemcitabine

- No prior camptothecin compounds

- Prior irinotecan allowed

- No other concurrent chemotherapy

Endocrine therapy

- Not specified

Radiotherapy

- See Disease Characteristics

- At least 14 days since prior radiotherapy

- No concurrent radiotherapy

Surgery

- Not specified

Other

- More than 30 days since prior clinical trial participation

- No other concurrent investigational medications

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

Nithya Ramnath, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Roswell Park Cancer Institute

Authority:

United States: Food and Drug Administration

Study ID:

CDR0000270343

NCT ID:

NCT00054288

Start Date:

August 2001

Completion Date:

June 2009

Related Keywords:

  • Unspecified Adult Solid Tumor, Protocol Specific
  • unspecified adult solid tumor, protocol specific
  • Neoplasms

Name

Location

Roswell Park Cancer InstituteBuffalo, New York  14263