Clinical trial · Interventional
Pemetrexed Plus Tarceva as Salvage Treatment in EGFR Overexpressed Metastatic Colorectal Cancer Patients Who Were Failed After Standard Chemotherapy
Pemetrexed Plus Tarceva as Salvage Treatment in EGFR Overexpressed Metastatic Colorectal Cancer Patients Who Were Failed After Standard Chemotherapy: A Phase II Single Arm Prospective Study
NCT03086538CI-TRIAL-00059137completedPhase 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)
This study is single center single arm prospective phase II study. In this study, efficacy and side effects of pemetrexed as salvage regimen on patients who failed all standard chemotherapy and total of 29 patients will be enrolled. Pemetrexed will be continued until disease progression is happened.
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 |
|---|---|---|---|
| Colo-rectal Cancer | Colon Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Pemetrexed | Drug | Pemetrexed | ALIAS |
| Tarceva 100Mg Tablet | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Pemetrexed+Tarceva
- description
- Pemetrexed 500 mg/m2 IV Q 3 weeks Tarceva 100mg once daily, continous
- interventionNames
- Drug: Pemetrexed
- Drug: Tarceva 100Mg Tablet
Primary outcomes (1)
- measure
- Overall Response Rate
- timeFrame
- 6 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
Show eligibility criteria text
Inclusion Criteria: * Advanced colorectal cancer failed from all standard chemotherapy * History of refractoriness from chemotherapy including 5-FU, Oxaliplatin, Irinotecan * Oral 5-FU agents are included standard chemotherapy * Targeted agents such as cetuximab or bevacizumab are not included in inclusion criteria * Patient must have willingness and ability to comply with the study protocol including visiting hospital for test and treatment during trial * ECOG performance status 0\~2 * Measurable lesion (RECIST 1.1) must exist * Expected survival should be more than 3 months from first dose of pemetrexed * Adequate organ function as defined as below estimated 28 days before first doe of pemetrexed: Exclusion Criteria: * Poor performance status (ECOG PS ≥ 3) * Patient can not take folic acid or Vitamin B12. * History of previous treatment with pemetrexed * History of malignant disease, except: non-melanoma skin cancer that properly treated, cured uterine cervical cancer or other solid tumor without evidence of recurrence within 5 years * Patient can not swallow oral pills. * Treatment with medication of clinical trial within 14 days (or longer duration according to specific agents) * Systemic chemotherapy or radiation (except palliative purpose) within 3 weeks (or longer duration according to specific agents) * Toxicity from previous treatment as CTCAE grade \> 1, except alopecia * bowel obstruction or CTCAE grade 3/4 upper GI bleeding before 4 weeks * QTc prolongation (QTc \> 480msec) at resting is documented more than twice within 24 hours or family history of QT prolongation syndrome
References
Publications (1)
- DERIVEDKim ST, Hong JY, Lee J, Park JO, Lim HY, Kang WK, Park YS. Pemetrexed/Erlotinib as a Salvage Treatment in Patients with High EGFR-Expressing Metastatic Colorectal Cancer Following Failure of Standard Chemotherapy: A Phase II Single-Arm Prospective Study. Target Oncol. 2020 Feb;15(1):67-73. doi: 10.1007/s11523-019-00691-z. PMID 31820199