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Combination Chemotherapy in Treating Patients With Advanced Cancer

A Phase I Study of 3-Aminopyridine-2-Carboxaldehyde Thiosemicarbazone (3-AP, Triapine) Administered Daily x 5 in Combination With Cisplatin

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00024323
Enrollment
Unknown
Registered
2003-06-20
Start date
2001-03-31
Completion date
2003-06-30
Last updated
2013-07-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Unspecified Adult Solid Tumor, Protocol Specific

Keywords

unspecified adult solid tumor, protocol specific

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.

Interventions

DRUGcisplatin
DRUGtriapine

Sponsors

Vion Pharmaceuticals
Lead SponsorINDUSTRY

Study design

Primary purpose
TREATMENT

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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)

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 11, 2026