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

Primary Purpose

Unspecified Adult Solid Tumor, Protocol Specific

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
cisplatin
paclitaxel
triapine
Sponsored by
Vion Pharmaceuticals
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Unspecified Adult Solid Tumor, Protocol Specific focused on measuring unspecified adult solid tumor, protocol specific

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Albert Einstein Comprehensive Cancer Center
  • New York Presbyterian Hospital - Cornell Campus

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
June 6, 2001
Last Updated
July 17, 2013
Sponsor
Vion Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT00016874
Brief Title
3-AP Plus Cisplatin and Paclitaxel in Treating Patients With Advanced or Metastatic Cancer
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2007
Overall Recruitment Status
Completed
Study Start Date
December 2000 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
January 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Vion Pharmaceuticals

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Unspecified Adult Solid Tumor, Protocol Specific
Keywords
unspecified adult solid tumor, protocol specific

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
cisplatin
Intervention Type
Drug
Intervention Name(s)
paclitaxel
Intervention Type
Drug
Intervention Name(s)
triapine

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mario Sznol, MD
Organizational Affiliation
Vion Pharmaceuticals
Official's Role
Study Chair
Facility Information:
Facility Name
Albert Einstein Comprehensive Cancer Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10461
Country
United States
Facility Name
New York Presbyterian Hospital - Cornell Campus
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States

12. IPD Sharing Statement

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

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