Ovarian Cancer Clinical Trial
BCX-1777 in Treating Patients With Refractory Cancer
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.
Full 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.
Eligibility Criteria
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
Creatinine clearance at least 50 mL/min
Cardiovascular
No American Heart Association class III or IV cardiac disease
Other
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception
HIV negative
No active systemic infection requiring IV antibiotics
PRIOR CONCURRENT THERAPY:
Biologic therapy
Not specified
Chemotherapy
Not specified
Endocrine therapy
Concurrent corticosteroids allowed provided the patient is on a stable regimen
Radiotherapy
Not specified
Surgery
Not specified
Other
Recovered from prior therapy
No grade 2-4 toxicity
More than 3 weeks since prior antineoplastic and/or investigational therapy
No other concurrent systemic antineoplastic or investigational therapy
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There is 1 Location for this study
Cleveland Ohio, 44195, United States
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