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

NCT ID: NCT00016874

Last Updated: 2013-07-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Study Classification: INTERVENTIONAL
• Study Start Date: 2000-12-31
• Study Completion Date: 2008-01-31

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, cisplatin, and paclitaxel in treating patients who have advanced or metastatic cancer.

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.

Conditions

Unspecified Adult Solid Tumor, Protocol Specific

Study Design

• Primary Study Purpose: TREATMENT

Interventions

cisplatin

Intervention Type: DRUG

paclitaxel

Intervention Type: DRUG

triapine

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Vion Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Principal Investigators

Mario Sznol, MD

Role: STUDY_CHAIR

Vion Pharmaceuticals

Locations

New York Presbyterian Hospital - Cornell Campus

New York, New York, United States

Albert Einstein Comprehensive Cancer Center

The Bronx, New York, United States

Countries

United States

Other Identifiers

CDR0000068591

Identifier Type: REGISTRY

Identifier Source: secondary_id

AECM-1200012380

Identifier Type: -

Identifier Source: secondary_id

NCI-V01-1658

Identifier Type: -

Identifier Source: secondary_id

VION-CLI-015

Identifier Type: -

Identifier Source: org_study_id