Irinotecan and Gemcitabine in Treating Patients With Refractory Advanced Solid Tumors

NCT00054288 | Completed Phase 1 DMC

• 2 other identifiers: CDR0000270343RPCI-DS-01-18
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Unspecified Adult Solid Tumor, Protocol Specific

Keywords

unspecified adult solid tumor, protocol specific

Interventions

gemcitabine hydrochloride DRUG

irinotecan hydrochloride DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Roswell Park Cancer Institute: lead

Study Sites (1)

Roswell Park Cancer Institute

Buffalo, New York, 14263-0001, United States

Location

MeSH Terms

Interventions

Gemcitabine; Irinotecan

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Camptothecin; Alkaloids

Study Officials

• Nithya Ramnath, MD

  Roswell Park Cancer Institute

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: February 5, 2003
• First Posted: February 6, 2003
• Study Start: August 1, 2001
• Primary Completion: May 1, 2003
• Study Completion: June 1, 2009
• Last Updated: January 13, 2014

Record last verified: 2014-01

Locations

US (1)