Pemetrexed and Gemcitabine for Treatment Resistant Patients With Metastatic Colorectal Cancer and KRAS Mutations

Phase 2

Terminated

• Conditions: Metastatic Colorectal Cancer
• Interventions: Drug: Pemetrexed; Drug: Gemcitabine

• Registration Number: NCT01109615
• Lead Sponsor: Vejle Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-04
• Study First Submitted: 2010-04-20
• Study First Submitted QC: 2010-04-21
• Study First Posted: 2010-04-23
• Primary Completion: 2011-08
• Study Completion: 2012-03
• Status Verified: 2012-04
• Last Update Submitted: 2012-04-17
• Last Update Posted: 2012-04-19

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 40

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Chemotherapy	Pemetrexed	-
Chemotherapy	Gemcitabine	-

Primary Outcome Measures

Name	Time	Method
Response rate	Assessed every 3 weeks by CT and/or MR scan and evaluated according to RECIST 1.1. Up to 12 months.

Secondary Outcome Measures

Name	Time	Method
Progression free survival	Every 3 months until progression or death. Up to 12 months.
Overall survival	12 months.

Trial Locations

Locations (1)

Vejle Hospital; 🇩🇰 Vejle, Denmark