Pemetrexed Plus Tarceva as Salvage Treatment in EGFR Overexpressed Metastatic Colorectal Cancer Patients Who Were Failed After Standard Chemotherapy

• Status: Recruiting
• Trial end date: 2020-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Samsung Medical Center
• Treatments: Erlotinib Hydrochloride; Pemetrexed

Criteria

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