Clinical trial · Interventional
Taxotere, Cisplatin, and CPT-11 in Advanced Solid Tumor Malignancies
Phase I Study of Taxotere, Cisplatin, and CPT-11 in Advanced Solid Tumor Malignancies
NCT00251407CI-TRIAL-00007802completedPhase 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)
The purpose of this study is to find the highest dose of the combination of taxotere, cisplatin and CPT-11, that can be given without causing severe side effects. We also want to test the safety of this drug combination and see what effects (good and bad) it has on patients with advanced cancer for which there is no known curable treatment.
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 |
|---|---|---|---|
| Solid Tumor | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (3)
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- taxotere, cisplatin, irinotecan
- interventionNames
- Drug: Taxotere
- Drug: Cisplatin
- Drug: CPT-11
Primary outcomes (1)
- measure
- To assess the maximum tolerated dose of weekly taxotere, cisplatin and CPT-11 in patients with incurable solid tumor malignancies.
- timeFrame
- 3 years
Secondary outcomes (1)
- measure
- To define the dose-limiting toxicities of the combination of drugs.
- timeFrame
- 3 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed, incurable solid tumor malignancy * 18 years of age or older * ECOG performance status of \< or = to 2 * Life expectancy of greater than 12 weeks * WBC \> 3,000/mm3 * ANC \> 1,500/mm3 * Platelet count \> 100,000/mm3 * Total bilirubin within normal limits * SGOT \< 2.5 x ULN * Alkaline phosphatase \< 4 x ULN Exclusion Criteria: * Prior chemotherapy for the treatment of metastatic or recurrent cancer * Prior radiotherapy to greater than or equal to 15% of bone marrow * Prior pelvic radiation therapy * Prior nitrosoureas or mitomycin C * Myocardial infarction in the past 6 months * Major surgery in past 2 weeks * Uncontrolled serious medical or psychiatric illness * Uncontrolled diarrhea * Peripheral neuropathy \> grade 1 * Pregnant or lactating women * Clinically apparent central nervous system metastases or carcinomatous meningitis
References
Publications (1)
- RESULTEnzinger PC, Ryan DP, Clark JW, Muzikansky A, Earle CC, Kulke MH, Meyerhardt JA, Blaszkowsky LS, Zhu AX, Fidias P, Vincitore MM, Mayer RJ, Fuchs CS. Weekly docetaxel, cisplatin, and irinotecan (TPC): results of a multicenter phase II trial in patients with metastatic esophagogastric cancer. Ann Oncol. 2009 Mar;20(3):475-80. doi: 10.1093/annonc/mdn658. Epub 2009 Jan 12. PMID 19139178