Epirubicin Plus Irinotecan in Treating Patients With Advanced Cancer

NCT00020748 | Completed Phase 1

• 5 other identifiers: CDR0000068710P30CA051008GUMC-00191GUMC-072000-001NCI-G01-1956
• 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 epirubicin plus irinotecan in treating patients who have advanced cancer.

Conditions

Unspecified Adult Solid Tumor, Protocol Specific

Keywords

unspecified adult solid tumor, protocol specific

Interventions

epirubicin 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 documented incurable malignancy for which there is no beneficial standard therapy * Locally unresectable or metastatic disease PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * ECOG 0-2 Life expectancy: * At least 8 weeks Hematopoietic: * WBC at least 3,000/mm\^3 * Granulocyte count at least 1,500/mm\^3 * Platelet count at least 100,000/mm\^3 Hepatic: * Bilirubin no greater than 1.2 times upper limit of normal (ULN) * SGOT and SGPT no greater than 2 times ULN Renal: * Creatinine no greater than 1.5 mg/dL OR * Creatinine clearance at least 60 mL/min Cardiovascular: * Ejection fraction at least 50% by MUGA scan * No congestive heart failure Other: * Maintaining a reasonable state of nutrition * No frequent vomiting or severe anorexia * No weight loss greater than 10% of current body weight within the past 4 weeks * No other concurrent medical illness that would preclude study * Not pregnant or nursing * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: * No concurrent immunotherapy Chemotherapy: * Prior doxorubicin allowed if cumulative dose no greater than 240 mg/m2 Endocrine therapy: * Not specified Radiotherapy: * No concurrent radiotherapy Surgery: * Not specified Other: * Recovered from prior therapy

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

Sponsors & Collaborators

• Georgetown University: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Lombardi Cancer Center at Georgetown University Medical Center

Washington D.C., District of Columbia, 20007, United States

Location

MeSH Terms

Interventions

Epirubicin; Irinotecan

Intervention Hierarchy (Ancestors)

Doxorubicin; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Camptothecin; Alkaloids; Heterocyclic Compounds

Study Officials

• John L. Marshall, MD

  Lombardi Comprehensive Cancer Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 11, 2001
• First Posted: January 27, 2003
• Study Start: August 1, 2000
• Primary Completion: October 1, 2004
• Study Completion: October 1, 2004
• Last Updated: March 24, 2011

Record last verified: 2005-01

Locations

US (1)