Clinical trial · Interventional
Irinotecan Study For Cervical Cancer
An Open Labeled, Single-Arm, Multicentre Phase II Study To Evaluate The Efficacy And Safety Of Weekly Irinotecan Plus Cisplatin As First-Line Chemotherapy For Advanced Or Recurrent Squamous Cell Carcinoma Of The Uterine Cervix
NCT00136955CI-TRIAL-00018314completedPhase 2Results postedClinicalTrials.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 the study is to evaluate the efficacy and safety of Irinotecan plus cisplatin as first-line chemotherapy for advanced or recurrent cervical 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 |
|---|---|---|---|
| Uterine Cervical Neoplasms | Cervical Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Irinotecan | Drug | Irinotecan | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- irinitecan/cisplatin
- description
- experimental arm consists of patients who receive irinotecan/cisplatin
- interventionNames
- Drug: Irinotecan
Primary outcomes (2)
- measure
- Response to Treatment Based on Response Evaluation Criteria in Solid Tumors (RECIST) Criteria (Evaluable Population)
- timeFrame
- At baseline and every 8 weeks through end of treatment (21-28 days after last administration of study treatment)
- description
- Tumor response according to RECIST.
- measure
- Response to Treatment Based on RECIST Criteria (Intent-to-Treat [ITT] Population)
- timeFrame
- At baseline and every 8 weeks through end of treatment (21-28 days after last administration of study treatment)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically documented, advanced or recurrent squamous cell carcinoma of uterine cervix. Patients may have received concurrent (with radiotherapy) or (neo)adjuvant (before or after local treatment) chemotherapy for primary tumor providing that at least 6 months have passed from the completion of previous therapy and the diagnosis of recurrent disease was documented * Having measurable lesion(s), without previous radiation therapy. Exclusion Criteria: * Patients had ever received primary chemotherapy for cervical cancer other than mentioned previously (in the inclusion criteria). * Patients ever received cisplatin with total dose \> 300 mg/m2 and received radiotherapy or local treatment delivered to the target lesion.
References
Publications (0)
Data not yet available
No reference posted for this study.