AG2037 in Treating Patients With Advanced, Metastatic, or Recurrent Solid Tumors

NCT00017524 | Completed Phase 1 DMC

• 5 other identifiers: CDR0000068699UAB-0052AG-2037-003-A2UAB-F001227008NCI-G01-1954
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 3

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 AG2037 in treating patients who have advanced, metastatic, or recurrent solid tumors.

Conditions

Unspecified Adult Solid Tumor, Protocol Specific

Keywords

unspecified adult solid tumor, protocol specific

Interventions

pelitrexol 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 solid tumor * Advanced, metastatic, or recurrent disease * No curative therapy exists * Measurable or evaluable disease PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * WHO 0-2 Life expectancy: * At least 3 months Hematopoietic: * Absolute granulocyte count at least 1,500/mm\^3 * Platelet count at least 100,000/mm\^3 * Hemoglobin at least 9 g/dL Hepatic: * Bilirubin no greater than 1.5 mg/dL (unless due to Gilbert's syndrome) * SGOT OR SGPT no greater than 2 times upper limit of normal (ULN) (5 times ULN if liver metastases present) Renal: * Creatinine no greater than 1.5 mg/dL * Creatinine clearance at least 60 mL/min Other: * No unstable or severe concurrent medical condition that would preclude study participation * No sociological or familial condition that would preclude study compliance * No psychological or addictive disorder that would preclude study compliance * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: * Not specified Chemotherapy: * At least 4 weeks since prior chemotherapy (6 weeks for nitrosourea or mitomycin) and recovered Endocrine therapy: * Not specified Radiotherapy: * At least 4 weeks since prior radiotherapy and recovered * No prior radiotherapy to more than 40% of bone marrow Surgery: * Not specified Other: * At least 2 weeks since prior blood transfusions * At least 4 weeks since prior investigational agent and recovered * No prior glycinamide ribonucleotide formyltransferase (GARFT) inhibitor * No concurrent extradietary folate supplements * No concurrent allopurinol * No other concurrent anticancer or investigational agents

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

Sponsors & Collaborators

• University of Alabama at Birmingham: lead
• National Cancer Institute (NCI): collaborator

Study Sites (3)

University of Alabama at Birmingham Comprehensive Cancer Center

Birmingham, Alabama, 35294-3300, United States

Location

Arizona Cancer Center

Tucson, Arizona, 85724, United States

Location

H. Lee Moffitt Cancer Center and Research Institute

Tampa, Florida, 33612-9497, United States

Location

MeSH Terms

Interventions

pelitrexol

Study Officials

• Francisco Robert, MD, FACP

  University of Alabama at Birmingham

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 6, 2001
• First Posted: January 27, 2003
• Study Start: March 1, 2001
• Study Completion: November 1, 2004
• Last Updated: December 16, 2013

Record last verified: 2012-11

Locations

US (3)