Status:
COMPLETED
BCX-1777 in Treating Patients With Refractory Cancer
Lead Sponsor:
BioCryst Pharmaceuticals
Conditions:
Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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...
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 i...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
April 1 2003
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00073944
Start Date
April 1 2003
Last Update
May 30 2013
Active Locations (1)
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1
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, United States, 44195