Clinical trial · Interventional
Pemetrexed and Gemcitabine for Treatment Resistant Patients With Metastatic Colorectal Cancer and KRAS Mutations
Phase II Study of Pemetrexed and Gemcitabine for Treatment Resistant Patients With Metastatic Colorectal Cancer and KRAS Mutations
NCT01109615CI-TRIAL-00006737PGterminatedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Lacking effect of treatment
Summary
Brief summary (as posted)
This study aims to investigate the efficacy and safety of the combination of pemetrexed and gemcitabine in heavily pre-treated, chemotherapy resistant colorectal cancer patients with 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 |
|---|---|---|---|
| Gemcitabine | Drug | Gemcitabine | ALIAS |
| Pemetrexed | Drug | Pemetrexed | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Chemotherapy
- interventionNames
- Drug: Pemetrexed
- Drug: Gemcitabine
Primary outcomes (1)
- measure
- Response rate
- timeFrame
- Assessed every 3 weeks by CT and/or MR scan and evaluated according to RECIST 1.1. Up to 12 months.
Secondary outcomes (2)
- measure
- Progression free survival
- timeFrame
- Every 3 months until progression or death. Up to 12 months.
- measure
- Overall survival
- timeFrame
- 12 months.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically verified adenocarcinoma in colon or rectum * Age \>18 * Metastatic colorectal cancer progressed after chemotherapy regimens containing fluoropyrimidines, oxaliplatin and irinotecan. * KRAS mutation in primary tumour or metastasis. * Measurable disease according to RECIST * ECOG performance status 0, 1 or 2 * Adequate function of liver, kidneys and bone marrow measured by biochemistry (max. 2 weeks before enrolment) * EDTA clearance: Uncorrected GFR \> 45 ml/min. * Neutrophilocytes ≥1.5 x 10\^9/l, leukocytes ≥3.0 x 10\^9/l, thrombocytes ≥100x10\^9/l * ALAT ≤ 3 x upper normal value (ULN), bilirubin ≤ 3 x upper normal value, Aptt and INR normal (or 2-3 at AC treatment). (ALAT and basic phosphatase ≤ 5 x upper normal value in case of liver metastases). * Blood samples and paraffin embedded tissue from primary tumour and/or metastases for translational research. * Fertile men and women (women \<2 year after last menstruation) must use efficient birth control. * Signed informed consent. Exclusion Criteria: * Clinically significant other concurrent disease making the patient unfit for participation in the study according to the investigator. * Other malignant disease within 5 years prior to study enrolment, except from planocellular and basal cell carcinomas in the skin or carcinoma-in-situ cervix. * Other experimental treatment within 30 days prior to treatment start. * Pregnant or breastfeeding women. * Clinical or radiological signs of CNS metastases. * Planned radiation of target lesions. * Concurrent vaccination against yellow fever.
References
Publications (0)
Data not yet available
No reference posted for this study.