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Home > "3" Clinical Trials Conditions > 3-AP Plus Cisplatin and Paclitaxel in Treating Patients With Advanced or Metastatic Cancer  3-AP Plus Cisplatin and Paclitaxel in Treating Patients With Advanced or Metastatic Cancer
3-AP Plus Cisplatin and Paclitaxel in Treating Patients With Advanced or Metastatic Cancer
For Condition: unspecified adult solid tumor, protocol specific
Status: No longer recruiting
Sponsor(s): Vion Pharmaceuticals ,
Synopsis: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. PURPOSE: Phase I trial to study the effectiveness of combining 3-AP, cisplatin, and paclitaxel in treating patients who have advanced or metastatic cancer.
Details: OBJECTIVES: I. Determine the safety and tolerability of 3-AP, cisplatin, and paclitaxel in patients with advanced or metastatic cancer. II. Determine the toxic effects of this regimen in these patients. III. Determine the maximum tolerated dose and recommended phase II dose of this regimen in these patients. IV. Determine the pharmacokinetic parameters of this regimen in these patients. V. Determine the tumor response in patients treated with this regimen. PROTOCOL OUTLINE: This is a dose-escalation study. Patients receive 3-AP IV continuously over 96 hours on days 1-4 and paclitaxel IV over 3 hours followed by cisplatin IV over 1 hour on day 3. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients achieving complete response (CR) receive 1 additional course of therapy after documented CR. Patients with partial response or stable disease may receive therapy for up to 6 months. Cohorts of 1-6 patients receive escalating doses of 3-AP, paclitaxel, and cisplatin until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity. PROJECTED ACCRUAL: Approximately 25-30 patients will be accrued for this study.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Histologically confirmed progressive advanced or metastatic cancer; Failed 1 or more prior standard therapies for disease OR Unlikely to respond to any currently available therapies - Measurable or evaluable disease - No active CNS metastases; Previously treated CNS metastases allowed if no evidence of new CNS metastases and stable for at least 2 months --Prior/Concurrent Therapy-- - Biologic therapy: Concurrent hematopoietic growth factors allowed except if used prophylactically during first course of study therapy - Chemotherapy: More than 3 weeks since prior chemotherapy (6 weeks for nitrosourea or mitomycin) and recovered; More than 6 months since prior combination cisplatin and paclitaxel; Prior cisplatin or paclitaxel as single agents allowed; Prior 3-AP allowed - Endocrine therapy: Not specified - Radiotherapy: More than 3 weeks since prior radiotherapy and recovered; Concurrent radiotherapy to a single site of progressive disease allowed if site requires treatment within the first course of study therapy - Surgery: Not specified - Other: More than 3 weeks since any therapy for malignancy and recovered; No other concurrent investigational drugs without consent of sponsor --Patient Characteristics-- - Age: 18 and over - Performance status: ECOG 0-1 - Life expectancy: More than 3 months - Hematopoietic: Absolute neutrophil count at least 1,500/mm3; Platelet count at least 100,000/mm3; Hemoglobin at least 10 g/dL (transfusion allowed); No active bleeding or coagulation disorder (occult blood for gastrointestinal cancer allowed) - Hepatic: Bilirubin no greater than 1.5 mg/dL; ALT/AST no greater than 3 times upper limit of normal (ULN) (5 times ULN if liver metastases present); Alkaline phosphatase no greater than 3 times ULN (5 times ULN if liver metastases present); Albumin at least 3.0 g/dL; PT/PTT no greater than 1.5 times ULN - Renal: Creatinine no greater than 1.5 mg/dL - Cardiovascular: No active heart disease; No myocardial infarction within the past 3 months; No symptomatic coronary artery disease, heart block, or uncontrolled congestive heart failure - Pulmonary: No moderate to severe compromise in pulmonary function - Other: No mental deficits and/or psychiatric history that would preclude study; No active infection; No pre-existing severe hearing impairment; No pre-existing grade 2 or greater neuropathy; No prior severe allergic reaction to study drugs; No other life-threatening illness; No chronic toxic effects from prior chemotherapy greater than grade I; Not pregnant or nursing; Negative pregnancy test; Fertile patients must use effective contraception during and for 18 months after study
Total Enrollment:
Location and Contact Information:
Overall Study Official:
MarioSznol, Study Chair, Vion Pharmaceuticals
Albert Einstein Comprehensive Cancer Center
Bronx, New York, 10461
United States
New York Presbyterian Hospital - Cornell Campus
New York City, New York, 10021
United States
Additional Information:
Study ID Numbers: CDR0000068591; VION-CLI-015,AECM-1200012380,NCI-V01-1658
Study Start Date: December 2000
Record last reviewed: September 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00016874
Other Unspecified Adult Solid Tumor, Protocol Specific Studies:
1. Dimethylxanthenone Acetic Acid in Treating Patients With Solid Tumors
2. EF5 in Treating Patients With Solid Tumors
3. Exatecan Mesylate in Treating Patients With Advanced Solid Tumors and Kidney Dysfunction
4. Chemotherapy Plus Bone Marrow or Peripheral Stem Cell Transplantation in Treating Patients With Recurrent or Refractory Solid Tumors
5. Methylphenidate in Treating Patients With Melanoma
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3-AP Plus Cisplatin and Paclitaxel in Treating Patients With Advanced or Metastatic Cancer
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