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Everolimus and Capecitabine in Patients With Advanced Malignancy (m-TOR)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2008 by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA).
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
ClinicalTrials.gov Identifier:
NCT01079702
First received: March 2, 2010
Last updated: NA
Last verified: January 2008
History: No changes posted

March 2, 2010
March 2, 2010
April 2008
April 2010   (final data collection date for primary outcome measure)
Phase I part: Assessment of dose limiting toxicity and maximum tolerated dose. II part: efficacy and feasibility. Primary endpoint of the study will be response rate. [ Time Frame: During treatment: assessments on day 1 every cycle (3 weeks). After treatment: every 3 months during the first 2 years, and every 6 months thereafter ] [ Designated as safety issue: Yes ]
Three patients will be enrolled per dose level, starting at dose level 1. If one of the 3 patients develops dose-limiting toxicity at any dose level, 3 other patients will start at the same dose level. If 2 or more out of these 6 patients develop DLT, no further dose escalations will be performed. The MTD will be considered to be the dose given at the previous lower level. No intrapatient dose escalation will be applied.
Same as current
No Changes Posted
  • Time to treatment failure [ Time Frame: Every 3 months during the first 2 years, and every 6 months thereafter. ] [ Designated as safety issue: No ]
  • Toxicity profile. [ Time Frame: During treatment: assessments on day 1 every cycle (3 weeks). After treatment: every 3 months during the first 2 years, and every 6 months thereafter. ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Everolimus and Capecitabine in Patients With Advanced Malignancy
A Phase I/II, Non-randomized, Multi-center, Dose-escalating, Two-stage Efficacy and Feasibility Study of the Combination of Everolimus and Capecitabine in Patients With Advanced Malignancies

In the investigators study the investigators combine everolimus, administrated twice daily at a fixed total dose of 10 mg continuously with capecitabine administered bid for 14 days followed by 7 days rest. In this study, capecitabine will be dose escalated.

The results form preclinical studies suggest that mTOR inhibitors are promising drugs for the treatment of various types of cancer. Everolimus seems the most attractive mTOR inhibitor because of the favourable pharmacokinetic profile and possibility of oral administration. Based on preclinical findings, mTOR inhibitors may be more efficacious when used in a rational combination with other cancer regiments like cytostatic drugs. Indeed, several multiagent combinations are being investigated in clinical trials at the moment, and the results are promising.

In our study we combine everolimus, administrated twice daily at a fixed total dose of 10 mg continuously with capecitabine administered bid for 14 days followed by 7 days rest. In this study, capecitabine will be dose escalated. The first dose level of capecitabine is 500 mg/m2 twice daily. Three patients will be enrolled per dose level, starting at dose level 1. If one of the 3 patients develops dose-limiting toxicity at any dose level, 3 other patients will start at the same dose level. If 2 or more out of these 6 patients develop DLT, no further dose escalations will be performed. The MTD will be considered to be the dose given at the previous lower level. No intrapatient dose escalation will be applied.

Once the MTD of capecitabine is established, the phase II part of the study will start in which 25 patients with various malignancies will be enrolled to evaluate the efficacy and feasibility of the combination of everolimus and capecitabine.

Interventional
Phase 1
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Advanced Malignancies
  • Drug: Everolimus
    Everolimus, administrated twice daily at a fixed total dose of 10 mg continuously.
    Other Name: Certican
  • Drug: Capecitabine
    Capecitabine administered bid for 14 days followed by 7 days rest. In this study, capecitabine will be dose escalated. The first dose level of capecitabine is 500 mg/m2 twice daily.
    Other Name: Xeloda
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
35
January 2011
April 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients with histological or cytological confirmed malignancies
  • Measurable lesion according to RECIST criteria (only for the phase II part of the study)
  • ECOG / WHO performance status of 0-2
  • Age ≥ 18 years
  • Life expectancy of at least 3 months
  • Minimal acceptable safety laboratory values defined as:
  • WBC ≥ 3.0 x 109 /L
  • Platelet count ≥ 100 x 109 /L
  • Hepatic function as defined by serum bilirubin ≤ 1.5 x ULN, ALT or AST ≤ 2.5 x ULN, in case of liver metastases ≤ 5 x ULN
  • Renal function as defined by creatinine < 150μmol/L
  • Able and willing to give written informed consent
  • Able to swallow and retain oral medication
  • Able and willing to undergo blood sampling for pharmacokinetic and pharmacogenetic analysis
  • Mentally, physically and geographically able to undergo treatment and follow up.

Exclusion Criteria:

  • Patients with known alcoholism, drug addiction and/or psychotic disorders in the history that are not suitable for adequate follow up
  • Women who are pregnant or breast feeding
  • Women of childbearing potential who refuse to use a reliable contraceptive method throughout the study
  • Serious concomitant systemic disorder that would compromise the safety of the patient, at the discretion of the investigator
  • Any other medical condition that would interfere with study procedures and/or decrease safety of the protocol treatment
Both
18 Years and older
No
Contact: Hanneke Wilmink, MD, PhD +31 205665955 j.w.wilmink@amc.uva.nl
Contact: Dick Richel, MD, PhD +31 205665955 d.j.richel@amc.uva.nl
Netherlands
 
NCT01079702
AMCmedonc08/010
Yes
J.W.Wilmink, MD PhD, Academisch Medisch Centrum-Universiteit Amsterdam (AMC-UvA)
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Not Provided
Principal Investigator: Hanneke Wilmink, MD, PhD Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
January 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP