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Completed

NCT Number: NCT01097018

Perifosine Plus Capecitabine Versus Placebo Plus Capecitabine in Patients With Refractory Advanced Colorectal Cancer

The trial will compare the overall survival of perifosine plus capecitabine to placebo plus capecitabine in patients with refractory advanced colorectal cancer.

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Key information

Conditions

Colorectal Cancer Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Alhambra, California, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients must have failed available therapy for the treatment of advanced colorectal cancer, including fluoropyrimidine, irinotecan, oxaliplatin, bevacizumab and for K-ras wild-type (WT) patients, anti-EGFR antibody (cetuximab or panitumumab) containing therapies.
  • For oxaliplatin-based therapy, failure of therapy will also include patients who had oxaliplatin discontinued secondary to toxicity.
  • No prior exposure to capecitabine in the metastatic colorectal cancer setting, except limited-course radiosensitizing capecitabine
  • Patients must have at least one measurable lesion by RECIST criteria

Exclusion criteria

  • Patients with known dipyrimidine dehydrogenase (DPD) deficiency or prior severe reaction to 5-FU

Treatment and study plan

Capecitabine

Drug

1000 mg/m2 BID/ Days 1-14

Perifosine

Drug

50 mg daily x 21 days

Placebo

Drug

1 pill daily x 21 days

Primary outcomes

  1. Overall Survival

    Time frame: Monthly

Secondary outcomes

  1. Progression-free Survival

    Time frame: Every 6 weeks

Sponsors and collaborators

Lead sponsor

AEterna Zentaris

Industry

Registry information

Official study title

A Phase III Randomized Study to Assess the Efficacy and Safety of Perifosine Plus Capecitabine Versus Placebo Plus Capecitabine in Patients With Refractory Advanced Colorectal Cancer

Acronym: X-PECT

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Apr 1, 2010
Registry last updated
Jul 2, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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