Clinical trial · Interventional
Chemotherapy in Treating Patients With Advanced or Metastatic Solid Tumors
A Phase I, Pharmacokinetic, and Treatment Duration and Escalation Study of Intravenous Intoplicine Administered as a 5 to 21-Day Continuous Infusion Every 4 Weeks
NCT00003713CI-TRIAL-00034623completedPhase 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. PURPOSE: Phase I trial to study the effectiveness of intoplicine in treating patients who have advanced or metastatic solid tumors.
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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| intoplicine | Drug | — | UNRESOLVED |
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 120 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: Histologically or cytologically proven solid tumor refractory to conventional cytotoxic anticancer therapy or for which no curative therapy exists Measurable or evaluable disease No active, progressive brain metastases PATIENT CHARACTERISTICS: Age: 18 and over Performance status: SWOG 0-2 Life expectancy: At least 12 weeks Hematopoietic: Absolute neutrophil count at least 1500/mm3 Platelet count at least 100,000/mm3 Hemoglobin at least 9 g/dL Hepatic: Bilirubin no greater than 1.5 mg/dL SGOT/SGPT no greater than 3 times upper limit of normal No nonmalignant hepatic disease Renal: Creatinine no greater than 2.0 mg/dL Potassium and magnesium at least lower limit of normal (LLN) Calcium at least LLN Cardiovascular: QTc interval on echocardiogram less than 450 milliseconds No myocardial infarction within past 6 months No uncontrolled congestive heart failure No unstable angina No active cardiomyopathy No unstable ventricular arrhythmia No uncontrolled hypertension Other: Not pregnant or nursing Fertile patients must use effective contraception Must have functional central venous access device or percutaneous intravenous catheter No known hypersensitivity to intoplicine or its analogs No active alcoholism or drug addiction No uncontrolled, unstable psychotic disorders No serious infections No underlying medical conditions that may be aggravated by treatment PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: At least 3 weeks since prior chemotherapy (6 weeks for nitrosoureas and mitomycin) and recovered No other concurrent antineoplastic therapy Endocrine therapy: Not specified Radiotherapy: At least 3 weeks since prior radiotherapy (except short courses (no greater than 5 fractions) of nonmyelosuppressive, palliative radiotherapy) and recovered No concurrent radiotherapy Surgery: Not specified Other: At least 3 weeks since prior investigational therapy No other concurrent investigational therapy
References
Publications (0)
Data not yet available
No reference posted for this study.