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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


Phase 1
18 Years
N/A
Not Enrolling
Both
Unspecified Adult Solid Tumor, Protocol Specific

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Trial Information

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


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Mario Sznol, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Vion Pharmaceuticals

Authority:

United States: Federal Government

Study ID:

CDR0000068591

NCT ID:

NCT00016874

Start Date:

December 2000

Completion Date:

Related Keywords:

  • Unspecified Adult Solid Tumor, Protocol Specific
  • unspecified adult solid tumor, protocol specific
  • Neoplasm Metastasis

Name

Location

Albert Einstein Comprehensive Cancer CenterBronx, New York  10461
New York Presbyterian Hospital - Cornell CampusNew York, New York  10021