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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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Pharmacologic Actions
Radiation-Sensitizing Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014