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Home > "C" Clinical Trials Conditions > CP-609,754 in Treating Patients With Advanced Solid Tumors  CP-609,754 in Treating Patients With Advanced Solid Tumors
CP-609,754 in Treating Patients With Advanced Solid Tumors
For Condition: unspecified adult solid tumor, protocol specific
Status: No longer recruiting
Sponsor(s): National Cancer Institute (NCI) , H. Lee Moffitt Cancer Center and Research Institute
Synopsis: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase I trial to study the effectiveness of CP-609,754 in treating patients who have advanced solid tumors.
Details: OBJECTIVES: I. Determine the safety, tolerability, pharmacokinetics, and maximum tolerated dose of CP-609,754 in patients with advanced solid tumors. II. Determine the predictability, duration, intensity, onset, reversibility, and dose relationship of any observed toxicities in these patients when treated with this regimen. III. Determine any preliminary evidence of antitumor activity of this treatment as assessed by response rate and time to disease progression in this patient population. PROTOCOL OUTLINE: This is a dose escalation study. Patients receive oral CP-609,754 1-2 times daily. Treatment continues every 28 days for 12 courses in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of CP-609,754 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 6 patients experience dose limiting toxicities. Patients are followed at 4 weeks. PROJECTED ACCRUAL: Approximately 44-56 patients will be accrued for this study within 12 months.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Histologically or cytologically confirmed advanced solid tumor; No standard curative therapy exists OR Refractory OR Disease progression while on therapy - Measurable disease - No brain metastases or leptomeningeal disease --Prior/Concurrent Therapy-- - Biologic therapy: At least 4 weeks since prior immunotherapy and recovered; No prior bone marrow transplantation - Chemotherapy: At least 4 weeks since prior chemotherapy (6 weeks for carboplatin, nitrosoureas, or mitomycin) and recovered - Endocrine therapy: At least 1 week since prior hormonal therapy and recovered Concurrent hormone replacement therapy allowed; No concurrent chronic steroid therapy - Radiotherapy: At least 4 weeks since prior radiotherapy and recovered; No prior radiotherapy to study lesions or to more than 30% of bone marrow containing areas - Surgery: Not specified - Other: At least 4 weeks since other prior investigational drugs; No other concurrent investigational drugs; Any regimens for other concurrent diseases or medical conditions must be stable for at least 4 weeks --Patient Characteristics-- - Age: 18 and over - Performance status: ECOG 0-2 - Life expectancy: At least 12 weeks - Hematopoietic: Absolute neutrophil count at least 1,500/mm3; Platelet count at least 100,000/mm3 - Hepatic: Bilirubin no greater than 1.5 mg/dL; AST and ALT no greater than 2.5 times upper limit of normal (ULN) (no greater than 5 times ULN if liver metastases) - Renal: Creatinine no greater than 1.5 times ULN OR Creatinine clearance at least 60 mL/min - Cardiovascular: No prior hemorrhagic or thrombotic cerebrovascular events including transient ischemic attacks; No clinically significant or unstable cardiac disease; No myocardial infarction within past 6 months; No serious cardiac arrhythmia or conduction abnormality - Pulmonary: No chronic obstructive pulmonary disease requiring hospitalization within past year - Other: Not pregnant or nursing; Negative pregnancy test; Fertile patients must use effective barrier contraception; Female patients must use barrier contraception plus a second form of effective contraception for at least 3 months prior to and during study; No other serious concurrent systemic disorders that would preclude study; No uncontrolled diabetes mellitus, thyroid disease, or seizure disorder; No active neurologic or psychiatric disease; No clinically apparent uncontrolled infection (e.g., HIV, hepatitis B or C); No known sensitivity to imidazole containing drugs (e.g., clotrimazole, oxiconazole, sulconazole, econazole, etoconazole, metronidazole, or ketoconazole); No clinically significant gastrointestinal abnormalities requiring intravenous alimentation; No malabsorption syndrome or active peptic ulcer; No other lab abnormalities (i.e., electrolytes, uric acid, calcium, phosphorous, or glucose) that would preclude study; No other malignancy in past 5 years except nonmelanomatous skin cancer or carcinoma in situ of the breast or cervix
Total Enrollment:
Location and Contact Information:
Overall Study Official:
DanielSullivan, Study Chair, H. Lee Moffitt Cancer Center and Research Institute
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, 33612-9497
United States
Additional Information:
Study ID Numbers: CDR0000068077; NCI-G00-1824,PFIZER-A3321001,MCC-12222
Study Start Date: June 2000
Record last reviewed: March 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00006085
Other Unspecified Adult Solid Tumor, Protocol Specific Studies:
1. SU5416 in Treating Patients With Advanced Solid Tumors
2. Magnetic-Resonance-Guided Radiofrequency Ablation in Treating Patients With Primary Kidney Cancer, Liver Metastases, or Other Solid Tumors
3. E7070 in Treating Patients With Solid Tumors
4. UCN-01, Fluorouracil, and Leucovorin in Treating Patients With Metastatic or Unresectable Solid Tumors
5. Oxaliplatin in Treating Patients With Advanced Cancer Plus Liver Dysfunction
Related Studies:
Other unspecified adult solid tumor, protocol specific Clinical Trials
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CP-609,754 in Treating Patients With Advanced Solid Tumors
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