BCX-1777 in Treating Patients With Refractory Cancer

Sponsor

BioCryst Pharmaceuticals (Industry)

Overall Status

Completed

CT.gov ID

NCT00073944

Collaborator

(none)

Location

Study Details

Study Description

Brief Summary

RATIONALE: BCX-1777 may stop the growth of cancer cells by blocking the enzymes necessary for their growth.

PURPOSE: Phase I trial to study the effectiveness of BCX-1777 in treating patients who have refractory cancer.

Condition or Disease	Intervention/Treatment	Phase
Cancer	Drug: forodesine hydrochloride	Phase 1

Detailed Description

OBJECTIVES:

Primary

Determine the maximum tolerated dose of BCX-1777 in patients with refractory T-cell or non-T-cell malignancies.
Determine the safety and dose-limiting toxicity of this drug in these patients.

Secondary

Determine the pharmacokinetics of single oral and single and multiple IV doses of this drug in these patients.
Determine the oral bioavailability of this drug in these patients.
Determine, preliminarily, the antitumor activity of this drug in these patients.

OUTLINE: This is an open-label, nonrandomized, dose-escalation, multicenter study.

Courses 1 and 2: Patients receive oral BCX-1777 on days 1 and 15* and BCX-1777 IV over 30 minutes on days 8* and 22*.
Course 3: Beginning approximately 6 days* after the completion of courses 1 and 2, patients receive BCX-1777 IV over 30 minutes once daily on days 1-5 and 8-12 (total of 10 doses).

NOTE: *+/- 1 day

Patients with stable disease or better and no dose-limiting toxicity (DLT) may receive an additional 10-dose treatment course (as in course 3) after a 10- to 16-day drug-free interval.

Treatment continues in the absence of disease progression or unacceptable toxicity.

Cohorts of 3-6 patients receive escalating doses of BCX-1777 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience DLT.

Patients are followed at 14 and 30 days.

PROJECTED ACCRUAL: A total of 3-24 patients will be accrued for this study.

Study Design

Study Type:

Interventional

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Phase I Pharmacology Study Of Oral And Intravenous BCX-1777 In Patients With Refractory T-Cell And Non-T-Cell Malignancies

Study Start Date :

Apr 1, 2003

Actual Primary Completion Date :

Jan 1, 2005

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

DISEASE CHARACTERISTICS:

Histologically confirmed diagnosis of 1 of the following:
Hematologic malignancy that is refractory to at least 1 prior curative treatment
Non-hematologic tumor that is refractory to at least 2 prior therapies, with or without measurable disease, including the following:
Gastrointestinal adenocarcinoma of 1 of the following sites:
Pancreatic
Biliary
Gastric
Colorectal
Esophageal
Melanoma
Ovarian cancer
Astrocytoma brain tumor
Not immediately eligible for any other treatment that would be potentially curative or life-prolonging, in the opinion of the investigator
Patients who may be candidates for future bone marrow transplantation are eligible
No brain metastases (other than astrocytomas)
No clinically significant pleural effusion
No complete tumor obstruction (e.g., bronchus, ureter, or bowel)

PATIENT CHARACTERISTICS:

Age

18 and over

Performance status

ECOG 0-2 OR
Karnofsky 50-100%

Life expectancy

Not specified

Hematopoietic

WBC at least 3,500/mm^3
Absolute neutrophil count at least 1,500/mm^3
Platelet count greater than 50,000/mm^3
Hematocrit stable without the need for transfusion (epoetin alfa support allowed)

Hepatic

Bilirubin less than 1.5 times upper limit of normal (ULN) (unless due to Gilbert's syndrome)
SGOT and SGPT less than 2 times ULN
No active hepatitis B or C

Renal