Clinical trial · Interventional
Irinotecan and Panitumumab as 3rd Line Treatment for mCRC Without KRAS Mutations
A Phase II Study of Irinotecan and Panitumumab as 3rd Line Treatment of Patients With Metastatic Colorectal Cancer Without KRAS Mutations
NCT00792363CI-TRIAL-00007172completedPhase 2ClinicalTrials.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 investigate the effect and the side effect profile of irinotecan and panitumumab administered every 3 weeks as 3rd line treatment for patients with metastatic colorectal cancer without KRAS mutations.
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 |
|---|---|---|---|
| Metastatic Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Irinotecan | Drug | Irinotecan | ALIAS |
| Panitumumab | Drug | Panitumumab | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Response Rate
- timeFrame
- Every 9 weeks. Up to 6 months
Secondary outcomes (2)
- measure
- Overall survival
- timeFrame
- 6 months
- measure
- Progression free survival
- timeFrame
- 6 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically verified adenocarcinoma in colon or rectum with metastatic spread. * No mutations in the KRAS gene. * Resistance to 5-FU, oxaliplatin and irinotecan. * Age ≥18 years. * PS 0-2. * Measurable disease according to RECIST criteria. * Haematology: Neutrophilocytes ≥1.5 x 109/l, leukocytes ≥3.0 x 109/l, thrombocytes ≥100 and bilirubinaemia ≤3 x upper normal value. Samples no more than 4 weeks old. * Fertile women must present a negative pregnancy test and use secure birth control during and 3 months after treatment. * Acceptance that blod and tissue samples are kept for subsequent investigation of biomarkers. * Oral and written informed consent. Exclusion Criteria: * Other malignant disease within the past 5 years, excl. non-melanoma skin cancer and carcinoma in situ cervicis uteri. * Chemotherapy, radiotherapy or immunotherapy within the past 4 weeks. * Verified or clinically suspected CNS metastasis. * Other experimental treatment. * Serious medical disease according to investigator's judgement. * Pregnant or breastfeeding women. * Hypersensitivity to the active substance or to one or more of the auxiliary substances. * Patients with interstitial pneumonitis or pulmonary fibrosis.
References
Publications (0)
Data not yet available
No reference posted for this study.