Clinical trial · Interventional
Combination Chemotherapy in Treating Patients With Advanced Solid Tumors
A Phase I Trial of Fenretinide in Combination With Paclitaxel and Cisplatin
NCT00005819CI-TRIAL-00003550completedPhase 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: This phase I trial is studying the side effects and best dose of combination chemotherapy in treating patients with advanced 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 (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| cisplatin | Drug | Cisplatin | ALIAS |
| fenretinide | Drug | — | UNRESOLVED |
| paclitaxel | Drug | Paclitaxel | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Cohorts of 3-6 patients receive escalating doses of paclitaxel and cisplatin until the maximum tolerated dose (MTD) is determined.
- timeFrame
- Courses (7 days) repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed advanced solid tumor not amenable to conventional surgery, radiotherapy, or chemotherapy * No brain metastases or primary brain tumors PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * ECOG 0-1 Life expectancy: * At least 12 weeks Hematopoietic: * WBC at least 3,500/mm\^3 * Granulocyte count at least 1,500/mm\^3 * Platelet count at least 100,000/mm\^3 * Hemoglobin greater than 9.0 g/dL Hepatic: * Bilirubin less than 1.6 mg/dL * AST and ALT less than 2 times upper limit of normal * PT and PTT normal OR * INR less than 1.1 Renal: * Creatinine less than 1.5 mg/dL OR * Creatinine clearance greater than 60 mL/min Cardiovascular: * No New York Heart Association class III or IV heart disease Other: * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No extensive signs of macular degeneration, including exudative or atrophic macular lesions reducing corrected vision to less than 20/40 PRIOR CONCURRENT THERAPY: Biologic therapy: * Not specified Chemotherapy: * See Disease Characteristics * At least 3 weeks since prior chemotherapy (6 weeks for mitomycin or nitrosoureas) and recovered * Prior platinum-containing agents and taxane exposure allowed with no evidence of neurotoxicity Endocrine therapy: * Not specified Radiotherapy: * See Disease Characteristics * At least 4 weeks since prior radiotherapy and recovered Surgery: * Not specified Other: * No concurrent vitamin A supplements * No concurrent supplemental antioxidants
References
Publications (0)
Data not yet available
No reference posted for this study.