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

NCT01109615 | Terminated Phase 2 DMC

• 1 other identifier: 2010-018700-90
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Metastatic Colorectal Cancer

Keywords

Colorectal cancer; Metastatic colorectal cancer; Treatment resistant; Chemotherapy refractory; KRAS mutation

Outcome Measures

Primary Outcomes (1)

• Response rate

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

Secondary Outcomes (2)

• Progression free survival

  Every 3 months until progression or death. Up to 12 months.

• Overall survival

  12 months.

Study Arms (1)

Chemotherapy

EXPERIMENTAL

Drug: Pemetrexed; Drug: Gemcitabine

Interventions

Pemetrexed DRUG

400 mg/m2 on day 1 of a 3 weeks cycle

Chemotherapy

Gemcitabine DRUG

1000 mg/m2 intravenously on day 1 and 8 of a 3 weeks cycle

Chemotherapy

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Vejle Hospital: lead

Study Sites (1)

Vejle Hospital

Vejle, DK-7100, Denmark

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Pemetrexed; Gemcitabine

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal 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; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring

Study Officials

• Anders Jakobsen, DMSc

  Vejle Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 20, 2010
• First Posted: April 23, 2010
• Study Start: April 1, 2010
• Primary Completion: August 1, 2011
• Study Completion: March 1, 2012
• Last Updated: April 19, 2012

Record last verified: 2012-04

Locations

DK (1)