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

• Status: Completed
• Trial end date: 2008-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Vion Pharmaceuticals
• Treatments: Albumin-Bound Paclitaxel; Cisplatin; Paclitaxel

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