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

Metastatic Colorectal Cancer Clinical Trial

— PG  

Official title:

Phase II Study of Pemetrexed and Gemcitabine for Treatment Resistant Patients With Metastatic Colorectal Cancer and KRAS Mutations

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01109615
• Other study ID #: 2010-018700-90
• Status: Terminated
• Phase: Phase 2
• First received: April 20, 2010
• Last updated: April 17, 2012
• Start date: April 2010
• Est. completion date: March 2012

Study information

• Verified date: April 2012
• Source: Vejle Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Medicines AgencyDenmark: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 40
• Est. completion date: March 2012
• Est. primary completion date: August 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colorectal Neoplasms
• Metastatic Colorectal Cancer

Intervention

Drug:
• Pemetrexed
400 mg/m2 on day 1 of a 3 weeks cycle
• Gemcitabine
1000 mg/m2 intravenously on day 1 and 8 of a 3 weeks cycle

Locations

Country	Name	City	State
Denmark	Vejle Hospital	Vejle

Sponsors (1)

Lead Sponsor	Collaborator
Vejle Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Response rate		Assessed every 3 weeks by CT and/or MR scan and evaluated according to RECIST 1.1. Up to 12 months.	No
Secondary	Progression free survival		Every 3 months until progression or death. Up to 12 months.	No
Secondary	Overall survival		12 months.	No