Clinical trial · Interventional
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
NCT00024323CI-TRIAL-00011432completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Unspecified Adult Solid Tumor, Protocol Specific | Adult Solid Neoplasm | ALIAS | 0.85 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| cisplatin | Drug | Cisplatin | ALIAS |
| triapine | Drug | — | UNRESOLVED |
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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)
References
Publications (1)
- DERIVEDKunos 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. PMID 27878356