Everolimus and Capecitabine in Patients With Advanced Malignancy

NCT01079702 | Unknown Phase 1 DMC

• 1 other identifier: AMCmedonc08/010
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Advanced Malignancies

Outcome Measures

Primary Outcomes (1)

• 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.

  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.

  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

Secondary Outcomes (2)

• Time to treatment failure

  Every 3 months during the first 2 years, and every 6 months thereafter.

• Toxicity profile.

  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.

Interventions

Everolimus DRUG

Everolimus, administrated twice daily at a fixed total dose of 10 mg continuously.

Also known as: Certican

Capecitabine DRUG

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.

Also known as: Xeloda

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA): lead

Study Sites (2)

Academic Medical Center

Amsterdam, 1105 AZ, Netherlands

RECRUITING

Academic Medical Center

Amsterdam, Netherlands

RECRUITING

MeSH Terms

Interventions

Everolimus; Capecitabine

Intervention Hierarchy (Ancestors)

Sirolimus; Macrolides; Lactones; Organic Chemicals; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• Hanneke Wilmink, MD, PhD

  Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hanneke Wilmink, MD, PhD

CONTACT

+31 205665955; j.w.wilmink@amc.uva.nl

Dick Richel, MD, PhD

CONTACT

+31 205665955; d.j.richel@amc.uva.nl

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 2, 2010
• First Posted: March 3, 2010
• Study Start: April 1, 2008
• Primary Completion: April 1, 2010
• Study Completion: January 1, 2011
• Last Updated: March 3, 2010

Record last verified: 2008-01

Locations

NL (2)