Escalating Irinotecan (CPT-11) Administered 24 Hours Prior To Gemcitabine In Patients With Refractory Solid Tumors
18 Years
N/A
Both
Unspecified Adult Solid Tumor, Protocol Specific
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 Institute | Buffalo, New York 14263 |
