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A Phase I Dose-Escalation Study of AG2037 Administered Once Weekly for Three Weeks to Patients With Advanced Cancer


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Unspecified Adult Solid Tumor, Protocol Specific

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Trial Information

A Phase I Dose-Escalation Study of AG2037 Administered Once Weekly for Three Weeks to Patients With Advanced Cancer


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Francisco Robert, MD, FACP

Investigator Role:

Study Chair

Investigator Affiliation:

University of Alabama at Birmingham

Authority:

United States: Federal Government

Study ID:

CDR0000068699

NCT ID:

NCT00017524

Start Date:

March 2001

Completion Date:

Related Keywords:

  • Unspecified Adult Solid Tumor, Protocol Specific
  • unspecified adult solid tumor, protocol specific
  • Neoplasms

Name

Location

Arizona Cancer Center Tucson, Arizona  85724
H. Lee Moffitt Cancer Center and Research Institute Tampa, Florida  33612
University of Alabama at Birmingham Comprehensive Cancer Center Birmingham, Alabama  35294-3300