Clinical trial · Observational
An Observational Study of CPT-11 Plus Platinum Analogues Regimens and UGT1A1 Genotypes in Solid Tumors
A Prospective Observational Study of the Efficacy and Safety of CPT-11 Plus Platinum Analogues Regimens for UGT1A1 Genotype Guided Patients With Several Solid Tumors
NCT01040312CI-TRIAL-00038778completedClinicalTrials.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 examine the correlation between UGT1A1 genotypes and the safety of CPT-11 plus platinum analogues (cisplatin, carboplatin and nedaplatin) regimens for patients with lung cancer, cervical cancer, ovarian cancer and gastric cancer.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cervical Cancer | Malignant Cervical Neoplasm | CURATED_EXACT | 0.92 |
| Gastric Cancer (Inoperable and Recurrent) | Malignant Gastric Neoplasm | CURATED_BROADER | 0.80 |
| Non-small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
| Ovarian Cancer | Malignant Ovarian Neoplasm | CURATED_EXACT | 0.92 |
| Small Cell Lung Cancer | Lung Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CPT-11 | Drug | — | UNRESOLVED |
| Platinum analogues | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- UGT1A1 genotyped patients
- description
- UGT1A1 genotyped patients receive CPT-11 with platinum analogues
- interventionNames
- Drug: CPT-11
- Drug: Platinum analogues
Primary outcomes (1)
- measure
- Number of Participants with UGT1A1 Genotype with Severe Toxicities Induced by CPT-11 with Platinum Analogues
- timeFrame
- within 6 months
Secondary outcomes (2)
- measure
- Response Rate of Participants with UGT1A1 genotype to CPT-11 with Platinum Analogues
- timeFrame
- within 6 months
- measure
- Duration of Response to CPT-11 with Platinum Analogues in Participants with UGT1A1 Genotype
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
Inclusion Criteria: * Has small cell lung cancer, non-small cell lung cancer, cervical cancer, ovarian cancer and/or gastric cancer * Has UGT1A1 genotype \*1/\*6, \*1/\*28, \*6/\*6, \*28/\*28 and \*6/\*28 * Is receiving CPT-11 plus platinum analogue (cisplatin, carboplatin and nedaplatin) regimens (with or without molecular targeted agents) Exclusion Criteria: * Has contraindication for CPT-11 * Has an Eastern Cooperative Oncology Group (ECOG) performance score (PS) of 3-4
References
Publications (0)
Data not yet available
No reference posted for this study.