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

June 6, 2001
December 12, 2013
March 2001
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Complete list of historical versions of study NCT00017524 on ClinicalTrials.gov Archive Site
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AG2037 in Treating Patients With Advanced, Metastatic, or Recurrent Solid Tumors
A Phase I Dose-Escalation Study of AG2037 Administered Once Weekly for Three Weeks to Patients With Advanced Cancer

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.

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.

Interventional
Phase 1
Masking: Open Label
Primary Purpose: Treatment
Unspecified Adult Solid Tumor, Protocol Specific
Drug: pelitrexol
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
22
November 2004
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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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00017524
CDR0000068699, UAB-0052, AG-2037-003-A2, UAB-F001227008, NCI-G01-1954
Yes
University of Alabama at Birmingham
University of Alabama at Birmingham
National Cancer Institute (NCI)
Study Chair: Francisco Robert, MD, FACP University of Alabama at Birmingham
University of Alabama at Birmingham
November 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP