Exatecan Mesylate in Treating Patients With Advanced Solid Tumors and Kidney Dysfunction

NCT00045318 | Completed Phase 1

• 4 other identifiers: DAIICHI-8951A-PRT026UCLA-0201008CDR0000256866NCI-G02-2103
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 5

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase I trial to study the effectiveness of exatecan mesylate in treating patients who have advanced solid tumors and kidney dysfunction.

Conditions

Unspecified Adult Solid Tumor, Protocol Specific

Keywords

unspecified adult solid tumor, protocol specific

Interventions

exatecan mesylate 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 refractory to standard therapy or for which no standard therapy exists * Renal function as defined by the following parameters: * Normal (creatinine clearance (CrCl) greater than 80 mL/min) * Mild dysfunction (CrCl 50-80 mL/min) * Moderate dysfunction (CrCl 30-50 mL/min) * Severe dysfunction (CrCl less than 30 mL/min) * End-stage renal disease (requiring dialysis) * No symptomatic or active brain metastases (e.g., edema or progression on CT scan or MRI) PATIENT CHARACTERISTICS: Age * 18 and over Performance status * ECOG 0-2 Life expectancy * At least 12 weeks Hematopoietic * Absolute neutrophil count at least 1,500/mm3 * Platelet count at least 100,000/mm3 * Hemoglobin at least 9.0 g/dL Hepatic * Bilirubin normal * AST or ALT no greater than 2 times upper limit of normal * Albumin at least 2.8 g/dL Renal * See Disease Characteristics Cardiovascular * No active congestive heart failure * No uncontrolled angina * No myocardial infarction within the past 6 months Other * No concurrent serious infection * No other life-threatening illness * No overt psychosis or mental disability or other incompetency that would preclude informed consent * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy * No concurrent anticancer biologic therapy Chemotherapy * At least 4 weeks since prior chemotherapy (6 weeks for mitomycin or nitrosourea) and recovered * No prior exatecan mesylate * No other concurrent anticancer chemotherapy Endocrine therapy * No concurrent anticancer hormonal therapy * Concurrent megestrol for appetite stimulation allowed Radiotherapy * At least 4 weeks since prior radiotherapy and recovered * No concurrent anticancer radiotherapy Surgery * At least 4 weeks since prior major surgery and recovered * No concurrent anticancer surgery Other * At least 4 weeks since prior investigational drugs including analgesics or antiemetics * At least 1 week since prior grapefruit juice * No other concurrent anticancer therapy * No other investigational drugs during and for 4 weeks after study * No concurrent grapefruit juice * No other concurrent anticancer cytotoxic therapy * Concurrent chronic hemodialysis or ambulatory peritoneal dialysis allowed

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

Sponsors & Collaborators

• Jonsson Comprehensive Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (5)

Jonsson Comprehensive Cancer Center, UCLA

Los Angeles, California, 90095, United States

Location

Brooke Army Medical Center

Fort Sam Houston, Texas, 78234, United States

Location

Cancer Therapy and Research Center

San Antonio, Texas, 78229, United States

Location

St. Luke's Lutheran Hospital

San Antonio, Texas, 78229, United States

Location

Veterans Affairs Medical Center - San Antonio (Murphy)

San Antonio, Texas, 78284, United States

Location

MeSH Terms

Interventions

exatecan

Study Officials

• Carolyn Britten, MD

  Jonsson Comprehensive Cancer Center

  STUDY CHAIR

Study Design

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

Study Record Dates

• First Submitted: September 6, 2002
• First Posted: January 27, 2003
• Study Start: May 1, 2002
• Study Completion: October 1, 2007
• Last Updated: July 10, 2013

Record last verified: 2003-04

Locations

US (5)