Status:
TERMINATED
Alvocidib in Treating Patients With Locally Advanced or Metastatic Solid Tumors
Lead Sponsor:
National Cancer Institute (NCI)
Conditions:
Unspecified Adult Solid Tumor, Protocol Specific
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
This phase I trial is studying the side effects and best dose of alvocidib in treating patients with locally advanced or metastatic solid tumors. Drugs used in chemotherapy, such as alvocidib, work in...
Detailed Description
PRIMARY OBJECTIVES: I. Determine the toxicity profile and dose-limiting toxicity of flavopiridol (alvocidib) in patients with locally advanced or metastatic solid tumors. II. Determine the maximum t...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Histologically or cytologically confirmed solid tumor
- Locally advanced or metastatic disease for which curative treatment does not exist or is no longer effective
- Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR ≥ 10 mm by spiral CT scan
- No previously irradiated\* measurable lesion unless lesion demonstrates progressive disease OR there are other measurable lesions outside the irradiated\* field
- The following are not considered measurable disease:
- Bone lesions
- Leptomeningeal disease
- Ascites
- Pleural or pericardial effusion
- Lymphangitis cutis/pulmonis
- Abdominal masses that are not confirmed and followed by imaging techniques
- Cystic lesions
- No uncontrolled brain metastases
- Performance status - ECOG 0-1
- At least 6 months
- Absolute neutrophil count ≥ 1,500/mm\^3
- Platelet count ≥ 100,000/mm\^3
- AST and ALT ≤ 2.5 times upper limit of normal (ULN)
- Bilirubin ≤ 1.5 times ULN
- Creatinine ≤ 1.5 times ULN
- No symptomatic congestive heart failure
- No unstable angina pectoris
- No uncontrolled cardiac arrhythmia
- No uncontrolled hypertension
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No history of allergic reaction attributed to compounds of similar chemical or biological composition to flavopiridol
- No ongoing or active infection
- No uncontrolled illness
- No psychiatric illness or social situation that would preclude study compliance
- More than 12 weeks since prior hepatic arterial chemoembolization
- More than 4 weeks since prior systemic chemotherapy
- No prior flavopiridol
- See Disease Characteristics
- More than 12 weeks since prior radioactive metaiodobenzylguanidine (MIBG)
- More than 4 weeks since prior external beam radiotherapy
- Recovered from all prior tumor-specific therapy
- More than 4 weeks since prior investigational tumor-specific therapy
- Concurrent octreotide for control of carcinoid syndrome allowed
- No concurrent combination anti-retroviral therapy for HIV-positive patients
- No other concurrent tumor-specific therapy
- No other concurrent investigational therapy
- No other concurrent anticancer therapy
Exclusion
Key Trial Info
Start Date :
February 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT00112684
Start Date
February 1 2006
Last Update
February 24 2014
Active Locations (1)
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1
Ohio State University Medical Center
Columbus, Ohio, United States, 43210