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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 October 23, 2014