Combination Chemotherapy in Treating Patients With Advanced 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: NCT00024323
Recruitment Status : Completed
First Posted : June 20, 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 with cisplatin in treating patients who have advanced cancer.

Condition or disease Intervention/treatment Phase
Unspecified Adult Solid Tumor, Protocol Specific Drug: cisplatin Drug: triapine Phase 1

Detailed Description:


  • Determine the maximum tolerated dose of cisplatin when administered with 3-AP in patients with advanced cancer.
  • Determine the toxic effects of this regimen in these patients.
  • Determine the antitumor responses in patients treated with this regimen.

OUTLINE: This is a dose-escalation study of cisplatin.

Patients receive 3-AP IV over 2 hours on days 1-4 and cisplatin IV over 1 hour on days 2 and 3. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity.

Cohorts of 3-6 patients receive escalating doses of 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: A total of 15-25 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) Administered Daily x 5 in Combination With Cisplatin
Study Start Date : March 2001
Actual Study Completion Date : June 2003

Resource links provided by the National Library of Medicine

Drug Information available for: Cisplatin

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 malignant disease that has failed at least 1 conventional treatment or is unlikely to respond to current therapy
  • Measurable or evaluable disease

    • Elevated serum tumor marker considered evaluable disease
  • No known active CNS metastases

    • Previously treated CNS metastases with no evidence of new CNS metastases allowed if stable for at least 2 months



  • 18 and over

Performance status:

  • ECOG 0-1

Life expectancy:

  • More than 3 months


  • WBC at least 3,000/mm^3
  • 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 (except occult blood related to gastrointestinal cancer)


  • Bilirubin no greater than 2.0 mg/dL
  • ALT and AST no greater than 3 times upper limit of normal (ULN)
  • Alkaline phosphatase no greater than 5 times ULN
  • PT and 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
  • No uncontrolled arrhythmias
  • No uncontrolled congestive heart failure


  • No moderate to severe compromise of pulmonary function


  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No active infectious process
  • No pre-existing severe hearing impairment
  • No grade 2 or greater neuropathy
  • No other life threatening illness
  • No prior severe allergic reaction to cisplatin
  • No mental deficits and/or psychiatric history that would preclude study
  • No persistent chronic toxic effects from prior chemotherapy greater than grade 1


Biologic therapy:

  • At least 2 weeks since prior biologic therapy


  • More than 3 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered
  • At least 3 months since prior cisplatin or platinum analogue
  • No prior 3-AP

Endocrine therapy:

  • At least 2 weeks since prior hormonal therapy


  • More than 3 weeks since prior radiotherapy


  • At least 3 weeks since prior major surgery and recovered


  • No other concurrent investigational drugs
  • No other concurrent nephrotoxic drugs (e.g., aminoglycoside antibiotics)

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): NCT00024323

United States, Arizona
Arizona Clinical Research Center
Tucson, Arizona, United States, 85712
United States, Connecticut
Yale Comprehensive Cancer Center
New Haven, Connecticut, United States, 06520-8028
Sponsors and Collaborators
Vion Pharmaceuticals
Study Chair: Mario Sznol, MD Vion Pharmaceuticals

Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00024323     History of Changes
Other Study ID Numbers: VION-CLI-021
CDR0000068918 ( Registry Identifier: PDQ (Physician Data Query) )
First Posted: June 20, 2003    Key Record Dates
Last Update Posted: July 18, 2013
Last Verified: November 2002

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

Additional relevant MeSH terms:
Antineoplastic Agents