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

NCT03086538 | Completed Phase 2

• 1 other identifier: 2016-12-046
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Colo-rectal Cancer

Outcome Measures

Primary Outcomes (1)

• Overall Response Rate

  6 months

Study Arms (1)

Pemetrexed+Tarceva

EXPERIMENTAL

Pemetrexed 500 mg/m2 IV Q 3 weeks Tarceva 100mg once daily, continous

Drug: Pemetrexed; Drug: Tarceva 100Mg Tablet

Interventions

Pemetrexed DRUG

Pemetrexed is a multitarget antifolate (MTA) whose mechanism of action relies mainly on the inhibition of TS, with weaker secondary effects on glycinamide ribonucleotide formyltransferase (GARFT) and dihydrofolate reductase (DHFR), leading to impairment of DNA synthesis and repair.

Pemetrexed+Tarceva

Tarceva 100Mg Tablet DRUG

Erlotinib (tarceva) is oral epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI).

Pemetrexed+Tarceva

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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:

You may not qualify if:

• 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

Sponsors & Collaborators

• Samsung Medical Center: lead

Study Sites (1)

Samsung Medical Center

Seoul, 06351, South Korea

Location

Related Publications (1)

• Kim 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 DERIVED

MeSH Terms

Conditions

Colonic Neoplasms

Interventions

Pemetrexed; Erlotinib Hydrochloride; Tablets

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Dicarboxylic; Quinazolines; Dosage Forms; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Model Details: Pemetrexed 500 mg/m2 IV Q 3 weeks Tarceva 100mg once daily, continous

Study Record Dates

• First Submitted: March 16, 2017
• First Posted: March 22, 2017
• Study Start: May 30, 2017
• Primary Completion: January 30, 2020
• Study Completion: May 25, 2020
• Last Updated: June 15, 2022

Record last verified: 2022-06

Locations

KR (1)