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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of Alabama at Birmingham
ClinicalTrials.gov Identifier:
NCT00017524
First received: June 6, 2001
Last updated: December 12, 2013
Last verified: November 2012
  Purpose

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.


Condition Intervention Phase
Unspecified Adult Solid Tumor, Protocol Specific
Drug: pelitrexol
Phase 1

Study Type: Interventional
Study Design: Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase I Dose-Escalation Study of AG2037 Administered Once Weekly for Three Weeks to Patients With Advanced Cancer

Resource links provided by NLM:


Further study details as provided by University of Alabama at Birmingham:

Enrollment: 22
Study Start Date: March 2001
Study Completion Date: November 2004
Detailed Description:

OBJECTIVES:

  • Determine the maximum tolerated dose and dose-limiting toxic effects of AG2037 in patients with advanced, metastatic, or recurrent solid tumor.
  • Determine the safety and tolerance of this drug in these patients.
  • Assess the pharmacokinetics of this drug in these patients.
  • Document any antitumor effects of this drug in these patients.

OUTLINE: This is a dose-escalation, multicenter study.

Patients receive AG2037 IV weekly on weeks 1-3. Treatment repeats every 4 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.

Cohorts of 3-6 patients receive escalating doses of AG2037 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 6 patients experience dose-limiting toxicity.

Patients are followed weekly for 4 weeks.

PROJECTED ACCRUAL: A total of 18-60 patients will be accrued for this study.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00017524

Locations
United States, Alabama
University of Alabama at Birmingham Comprehensive Cancer Center
Birmingham, Alabama, United States, 35294-3300
United States, Arizona
Arizona Cancer Center
Tucson, Arizona, United States, 85724
United States, Florida
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, United States, 33612-9497
Sponsors and Collaborators
University of Alabama at Birmingham
Investigators
Study Chair: Francisco Robert, MD, FACP University of Alabama at Birmingham
  More Information

Additional Information:
No publications provided

Responsible Party: University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT00017524     History of Changes
Other Study ID Numbers: CDR0000068699, UAB-0052, AG-2037-003-A2, UAB-F001227008, NCI-G01-1954
Study First Received: June 6, 2001
Last Updated: December 12, 2013
Health Authority: United States: Federal Government

Keywords provided by University of Alabama at Birmingham:
unspecified adult solid tumor, protocol specific

ClinicalTrials.gov processed this record on April 15, 2014