Irinotecan and Gemcitabine in Treating Patients With Refractory Advanced Solid Tumors

NCT ID: NCT00054288

Last Updated: 2014-01-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Study Classification: INTERVENTIONAL
• Study Start Date: 2001-08-31
• Study Completion Date: 2009-06-30

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.

PURPOSE: Phase I trial to study the effectiveness of combining irinotecan with gemcitabine in treating patients who have refractory advanced solid tumors.

Detailed Description

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.

Conditions

Unspecified Adult Solid Tumor, Protocol Specific

Study Design

• Allocation Method: NON_RANDOMIZED
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

gemcitabine hydrochloride

Intervention Type: DRUG

irinotecan hydrochloride

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Roswell Park Cancer Institute

OTHER

Sponsor Role: lead

Responsible Party

Roswell Park Cancer Institute

Principal Investigators

Nithya Ramnath, MD

Role: STUDY_CHAIR

Roswell Park Cancer Institute

Locations

Roswell Park Cancer Institute

Buffalo, New York, United States

Countries

United States

Other Identifiers

RPCI-DS-01-18

Identifier Type: -

Identifier Source: secondary_id

CDR0000270343

Identifier Type: -

Identifier Source: org_study_id