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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 CenterTucson, Arizona  85724
H. Lee Moffitt Cancer Center and Research InstituteTampa, Florida  33612
University of Alabama at Birmingham Comprehensive Cancer CenterBirmingham, Alabama  35294-3300