Clinical trial · Interventional
3-AP Plus Cisplatin and Paclitaxel in Treating Patients With Advanced or Metastatic Cancer
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
NCT00016874CI-TRIAL-00011424completedPhase 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, cisplatin, and paclitaxel in treating patients who have advanced or metastatic 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 (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| cisplatin | Drug | Cisplatin | ALIAS |
| paclitaxel | Drug | Paclitaxel | ALIAS |
| triapine | Drug | — | UNRESOLVED |
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.