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

This study has been completed.
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00016874
First received: June 6, 2001
Last updated: July 17, 2013
Last verified: December 2007
  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, cisplatin, and paclitaxel in treating patients who have advanced or metastatic cancer.


Condition Intervention Phase
Unspecified Adult Solid Tumor, Protocol Specific
Drug: cisplatin
Drug: paclitaxel
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) In Combination With Cisplatin And Paclitaxel In Patients With Advanced And Metastatic Cancer

Resource links provided by NLM:


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

Study Start Date: December 2000
Study Completion Date: January 2008
Detailed Description:

OBJECTIVES:

  • 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.

  Eligibility

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

DISEASE CHARACTERISTICS:

  • 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

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Performance status:

  • ECOG 0-1

Life expectancy:

  • More than 3 months

Hematopoietic:

  • 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)

Hepatic:

  • 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

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, heart block, or uncontrolled congestive heart failure

Pulmonary:

  • No moderate to severe compromise in pulmonary function

Other:

  • 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

PRIOR CONCURRENT THERAPY:

Biologic therapy:

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

Chemotherapy:

  • 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

Radiotherapy:

  • 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

Surgery:

  • Not specified

Other:

  • More than 3 weeks since any therapy for malignancy and recovered
  • No other concurrent investigational drugs without consent of sponsor
  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: NCT00016874

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

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00016874     History of Changes
Other Study ID Numbers: VION-CLI-015, CDR0000068591, AECM-1200012380, NCI-V01-1658
Study First Received: June 6, 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:
Neoplasm Metastasis
Neoplastic Processes
Neoplasms
Pathologic Processes
Cisplatin
Paclitaxel
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Antineoplastic Agents, Phytogenic
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 31, 2014