- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00016874
3-AP Plus Cisplatin and Paclitaxel in Treating Patients With Advanced or Metastatic Cancer
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
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.
Study Overview
Status
Intervention / Treatment
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.
PROJECTED ACCRUAL: Approximately 25-30 patients will be accrued for this study.
Study Type
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
New York
-
Bronx, New York, United States, 10461
- Albert Einstein Comprehensive Cancer Center
-
New York, New York, United States, 10021
- New York Presbyterian Hospital - Cornell Campus
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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:
Age:
- 18 and over
Performance status:
- ECOG 0-1
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)
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 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
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- VION-CLI-015
- CDR0000068591 (Registry Identifier: PDQ (Physician Data Query))
- AECM-1200012380
- NCI-V01-1658
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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