Combination Chemotherapy in Treating Patients With Advanced Cancer

NCT ID: NCT00024323

Last Updated: 2013-07-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Study Classification: INTERVENTIONAL
• Study Start Date: 2001-03-31
• Study Completion Date: 2003-06-30

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 with cisplatin in treating patients who have advanced cancer.

Detailed Description

OBJECTIVES:

• Determine the maximum tolerated dose of cisplatin when administered with 3-AP in patients with advanced cancer.
• Determine the toxic effects of this regimen in these patients.
• Determine the antitumor responses in patients treated with this regimen.

OUTLINE: This is a dose-escalation study of cisplatin.

Patients receive 3-AP IV over 2 hours on days 1-4 and cisplatin IV over 1 hour on days 2 and 3. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity.

Cohorts of 3-6 patients receive escalating doses of 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: A total of 15-25 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

triapine

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed progressive malignant disease that has failed at least 1 conventional treatment or is unlikely to respond to current therapy
• Measurable or evaluable disease

• Elevated serum tumor marker considered evaluable disease
• No known active CNS metastases

• Previously treated CNS metastases with no evidence of new CNS metastases allowed if stable for at least 2 months

PATIENT CHARACTERISTICS:

Age:

• 18 and over

Performance status:

• ECOG 0-1

Life expectancy:

• More than 3 months

Hematopoietic:

• WBC at least 3,000/mm^3
• 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 (except occult blood related to gastrointestinal cancer)

Hepatic:

• Bilirubin no greater than 2.0 mg/dL
• ALT and AST no greater than 3 times upper limit of normal (ULN)
• Alkaline phosphatase no greater than 5 times ULN
• PT and 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
• No uncontrolled arrhythmias
• No uncontrolled congestive heart failure

Pulmonary:

• No moderate to severe compromise of pulmonary function

Other:

• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception
• No active infectious process
• No pre-existing severe hearing impairment
• No grade 2 or greater neuropathy
• No other life threatening illness
• No prior severe allergic reaction to cisplatin
• No mental deficits and/or psychiatric history that would preclude study
• No persistent chronic toxic effects from prior chemotherapy greater than grade 1

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• At least 2 weeks since prior biologic therapy

Chemotherapy:

• More than 3 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered
• At least 3 months since prior cisplatin or platinum analogue
• No prior 3-AP

Endocrine therapy:

• At least 2 weeks since prior hormonal therapy

Radiotherapy:

• More than 3 weeks since prior radiotherapy

Surgery:

• At least 3 weeks since prior major surgery and recovered

Other:

• No other concurrent investigational drugs
• No other concurrent nephrotoxic drugs (e.g., aminoglycoside antibiotics)

• 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

Arizona Clinical Research Center

Tucson, Arizona, United States

Yale Comprehensive Cancer Center

New Haven, Connecticut, United States

Countries

United States

References

Kunos CA, Chu E, Beumer JH, Sznol M, Ivy SP. Phase I trial of daily triapine in combination with cisplatin chemotherapy for advanced-stage malignancies. Cancer Chemother Pharmacol. 2017 Jan;79(1):201-207. doi: 10.1007/s00280-016-3200-x. Epub 2016 Nov 22.

Reference Type: DERIVED

PMID: 27878356 (View on PubMed)

Other Identifiers

CDR0000068918

Identifier Type: REGISTRY

Identifier Source: secondary_id

NCI-V01-1668

Identifier Type: -

Identifier Source: secondary_id

VION-CLI-021

Identifier Type: -

Identifier Source: org_study_id