Know Cancer

forgot password

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

Phase 2
18 Years
Not Enrolling
Metastatic Colorectal Cancer

Thank you

Trial Information

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

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.

Type of Study:


Study Design:

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

Outcome Measure:

Response rate

Outcome Time Frame:

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

Safety Issue:


Principal Investigator

Anders Jakobsen, DMSc

Investigator Role:

Study Chair

Investigator Affiliation:

Vejle Hospital


Denmark: Danish Medicines Agency

Study ID:




Start Date:

April 2010

Completion Date:

March 2012

Related Keywords:

  • Metastatic Colorectal Cancer
  • Colorectal cancer
  • Metastatic colorectal cancer
  • Treatment resistant
  • Chemotherapy refractory
  • KRAS mutation
  • Colorectal Neoplasms