NCT00827684

Brief Summary

The purpose of this study is to investigate the safety and efficacy of temsirolimus as a single drug, and of temsirolimus in combination with irinotecan in chemotherapy resistant patients with KRAS mutated colorectal cancer.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Mar 2009

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 22, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 23, 2009

Completed
1 month until next milestone

Study Start

First participant enrolled

March 1, 2009

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2011

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2011

Completed
Last Updated

June 8, 2011

Status Verified

June 1, 2011

Enrollment Period

1.8 years

First QC Date

January 22, 2009

Last Update Submit

June 7, 2011

Conditions

Metastatic Colorectal Cancer

Keywords

KRAS mutation

Outcome Measures

Primary Outcomes (1)

  • Objective response rates

Secondary Outcomes (3)

  • Progression free survival

  • Overall survival

  • Translational Research

Study Arms (2)

Response or stable disease

ACTIVE COMPARATOR

will receive Temsirolimus

Drug: Temsirolimus

Progression

EXPERIMENTAL

Will receive a combination of Temsirolimus and Irinotecan

Drug: IrinotecanDrug: Temsirolimus

Interventions

IrinotecanDRUG
Progression
TemsirolimusDRUG
ProgressionResponse or stable disease

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Histologically verified colorectal adenocarcinomas
  • Age \> 18 years and \< 70
  • Metastatic colorectal cancer refractory 5-FU, oxaliplatin and irinotecan containing treatment regimes
  • KRAS mutation detected by DxS kit in primary tumor or metastatic lesion.
  • Measurable disease according to RECIST
  • ECOG performance status 0, 1 or 2
  • Adequate renal, hepatic and haematological function
  • Normal serum cholesterol and triglycerides
  • Blood samples and available paraffin embedded tumor material for translational research studies
  • Fertile males and females (\< 2 years after last period for women) must use effective birth control
  • Signed Informed consent

You may not qualify if:

  • Clinically significant heart disease, active severe infections or other concurrent disease
  • Prior radiotherapy within 30 days of treatment start
  • Other experimental therapy within 30 days of treatment initiation
  • Patients who are breast feeding, childbearing or of childbearing potential without using dual effective contraception
  • Clinical or radiological evidence of CNS metastasis
  • Completed any major surgery, excision biopsy or significant traumatic lesion ≥ 4 weeks from start of treatment and completed any minor surgery ≥ 1 week prior to start of treatment
  • Insertion of a vascular access device is not considered major or minor surgery from the viewpoint of protocol eligibility
  • Patients must have fully recovered from the procedure and have a fully healed incision
  • Planned radiation therapy against target-lesions
  • Patients with significant non-healing wounds or ulcers
  • History or evidence of thrombotic or hemorrhagic disorders
  • Significant haemorrhage (\> 30 ml/bleeding episode in previous 3 months)
  • Haemoptysis (\> 5 ml fresh blood in previous 4 weeks)
  • Patients on full-dose anticoagulation (e.g., warfarin) are eligible provided that both of the following criteria are met:
  • The patient has an in-range INR (usually between 2 and 3) on a stable dose of oral anticoagulant or is on a stable dose of low molecular weight heparin
  • +6 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Rigshospitalet, Department of Oncology

Copenhagen, DK-2100, Denmark

Location

Vejle Hospital, Dept. of Oncology

Vejle, Denmark

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Irinotecantemsirolimus

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Intervention Hierarchy (Ancestors)

CamptothecinAlkaloidsHeterocyclic Compounds

Study Officials

  • Anders Jakobsen, MD, DMSc

    Vejle Hospital

    STUDY CHAIR

  • Karen-Lise G Spindler, MD, PhD

    Vejle Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 22, 2009

First Posted

January 23, 2009

Study Start

March 1, 2009

Primary Completion

January 1, 2011

Study Completion

June 1, 2011

Last Updated

June 8, 2011

Record last verified: 2011-06

Locations

DK(2)