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3-AP Plus Cisplatin and Paclitaxel in Treating Patients With Advanced or Metastatic Cancer

Sponsor
Vion Pharmaceuticals (Industry)
Overall Status
Completed
CT.gov ID
NCT00016874
Collaborator
(none)
2
Locations
85
Duration (Months)

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 1

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 Design

Study Type:
Interventional
Primary Purpose:
Treatment
Official Title:
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
Study Start Date :
Dec 1, 2000
Actual Study Completion Date :
Jan 1, 2008

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Albert Einstein Comprehensive Cancer Center Bronx New York United States 10461
    2 New York Presbyterian Hospital - Cornell Campus New York New York United States 10021

    Sponsors and Collaborators

    • Vion Pharmaceuticals

    Investigators

    • Study Chair: Mario Sznol, MD, Vion Pharmaceuticals

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00016874
    Other Study ID Numbers:
    • VION-CLI-015
    • CDR0000068591
    • AECM-1200012380
    • NCI-V01-1658
    First Posted:
    Sep 9, 2003
    Last Update Posted:
    Jul 18, 2013
    Last Verified:
    Dec 1, 2007
    Keywords provided by , ,
    unspecified adult solid tumor, protocol specific
    Additional relevant MeSH terms:
    Neoplasm Metastasis
    Paclitaxel
    Cisplatin

    Study Results

    No Results Posted as of Jul 18, 2013