Combination Chemotherapy in Treating Patients With Advanced Cancer

This study has been completed.
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00024323
First received: September 13, 2001
Last updated: July 17, 2013
Last verified: November 2002
  Purpose

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

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Study Start Date: March 2001
Study Completion Date: June 2003
Detailed Description:

OBJECTIVES:

  • 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • 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

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Performance status:

  • ECOG 0-1

Life expectancy:

  • More than 3 months

Hematopoietic:

  • 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)

Hepatic:

  • 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

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
  • No uncontrolled arrhythmias
  • No uncontrolled congestive heart failure

Pulmonary:

  • No moderate to severe compromise of pulmonary function

Other:

  • 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

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • At least 2 weeks since prior biologic therapy

Chemotherapy:

  • 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

Radiotherapy:

  • More than 3 weeks since prior radiotherapy

Surgery:

  • At least 3 weeks since prior major surgery and recovered

Other:

  • No other concurrent investigational drugs
  • No other concurrent nephrotoxic drugs (e.g., aminoglycoside antibiotics)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00024323

Locations
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
Investigators
Study Chair: Mario Sznol, MD Vion Pharmaceuticals
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00024323     History of Changes
Other Study ID Numbers: VION-CLI-021, CDR0000068918, NCI-V01-1668
Study First Received: September 13, 2001
Last Updated: July 17, 2013
Health Authority: United States: Federal Government

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

Additional relevant MeSH terms:
Cisplatin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on April 17, 2014