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)

June 6, 2001
September 9, 2003
July 18, 2013
December 2000
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Complete list of historical versions of study NCT00016874 on Archive Site
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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.


  • 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.

Phase 1
Primary Purpose: Treatment
Unspecified Adult Solid Tumor, Protocol Specific
  • Drug: cisplatin
  • Drug: paclitaxel
  • Drug: triapine
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
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January 2008
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  • 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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
United States
CDR0000068591 ( Registry Identifier: PDQ (Physician Data Query) )
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Vion Pharmaceuticals
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Study Chair: Mario Sznol, MD Vion Pharmaceuticals
National Cancer Institute (NCI)
December 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP