NCT00016874CompletedPhase 1
A Phase I Study Of 3-Aminopyridine-2-Carboxaldehyde Thiosemicarbazone (3-AP, Triapine) In Combination With Cisplatin And Paclitaxel In Patients With Advanced And Metastatic Cancer
Vion Pharmaceuticals3 sites in 1 countryStarted: December 1, 2000Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Locations
- 3
Study Overview
Brief Summary
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.
Detailed Description
OBJECTIVES:
- Determine the safety and tolerability of 3-AP, cisplatin, and paclitaxel in patients with advanced or metastatic cancer.
- Determine the toxic effects of this regimen in these patients.
- Determine the maximum tolerated dose and recommended phase II dose of this regimen in these patients.
- Determine the pharmacokinetic parameters of this regimen in these patients.
- Determine the tumor response in patients treated with this regimen.
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.
Study Design
- Study Type
- Interventional
- Primary Purpose
- Treatment
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion 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
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status:
- •Life expectancy:
- •More than 3 months
- •Hematopoietic:
- •Absolute neutrophil count at least 1,500/mm^3
- •Platelet count at least 100,000/mm^3
- •Hemoglobin at least 10 g/dL (transfusion allowed)
- •No active bleeding or coagulation disorder (occult blood for gastrointestinal cancer allowed)
- •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
- •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
- •No moderate to severe compromise in pulmonary function
- •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 participation
- •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
- +4 more not shown
Exclusion Criteria
- Not provided
Investigators
Study Sites (3)
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