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

NCT00016874 | Completed Phase 1

• 4 other identifiers: VION-CLI-015CDR0000068591AECM-1200012380NCI-V01-1658
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 2

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.

Conditions

Unspecified Adult Solid Tumor, Protocol Specific

Keywords

unspecified adult solid tumor, protocol specific

Interventions

cisplatin DRUG

paclitaxel DRUG

triapine DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Vion Pharmaceuticals: lead

Study Sites (2)

New York Presbyterian Hospital - Cornell Campus

New York, New York, 10021, United States

Location

Albert Einstein Comprehensive Cancer Center

The Bronx, New York, 10461, United States

Location

MeSH Terms

Interventions

Cisplatin; Paclitaxel; 3-aminopyridine-2-carboxaldehyde thiosemicarbazone

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Study Officials

• Mario Sznol, MD

  Vion Pharmaceuticals

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Purpose: TREATMENT
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: June 6, 2001
• First Posted: September 9, 2003
• Study Start: December 1, 2000
• Study Completion: January 1, 2008
• Last Updated: July 18, 2013

Record last verified: 2007-12

Locations

US (2)