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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00016874
Recruitment Status : Completed
First Posted : September 9, 2003
Last Update Posted : July 18, 2013
Information provided by:
National Cancer Institute (NCI)

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
Unspecified Adult Solid Tumor, Protocol Specific Drug: cisplatin Drug: paclitaxel Drug: triapine Phase 1

Detailed Description:


  • 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 : Interventional  (Clinical Trial)
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 : December 2000
Actual Study Completion Date : January 2008

Resource links provided by the National Library of Medicine

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • 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



  • 18 and over

Performance status:

  • ECOG 0-1

Life expectancy:

  • More than 3 months


  • 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


  • 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


Biologic therapy:

  • Concurrent hematopoietic growth factors allowed except if used prophylactically during first course of study therapy


  • 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


  • 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


  • Not specified


  • More than 3 weeks since any therapy for malignancy and recovered
  • No other concurrent investigational drugs without consent of sponsor

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00016874

United States, New York
Albert Einstein Comprehensive Cancer Center
Bronx, New York, United States, 10461
New York Presbyterian Hospital - Cornell Campus
New York, New York, United States, 10021
Sponsors and Collaborators
Vion Pharmaceuticals
Study Chair: Mario Sznol, MD Vion Pharmaceuticals Identifier: NCT00016874     History of Changes
Other Study ID Numbers: VION-CLI-015
CDR0000068591 ( Registry Identifier: PDQ (Physician Data Query) )
First Posted: September 9, 2003    Key Record Dates
Last Update Posted: July 18, 2013
Last Verified: December 2007

Keywords provided by National Cancer Institute (NCI):
unspecified adult solid tumor, protocol specific

Additional relevant MeSH terms:
Neoplasm Metastasis
Neoplastic Processes
Pathologic Processes
Albumin-Bound Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action