Study of Perifosine + Capecitabine for Colon Cancer Patients

NCT01048580 | Completed Phase 1

• 1 other identifier: Perifosine 141
• Study Type: interventional
• Target: 10
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is a Phase I study of Perifosine + Capecitabine for patients with advanced colon cancer.

Conditions

Colon Cancer

Keywords

Perifosine; Capecitabine; Colon Cancer

Outcome Measures

Primary Outcomes (1)

• Safety and tolerability of the combination of perifosine and capecitabine (i.e., dose limiting toxicity)

  The maximum tolerated dose (MTD) is defined in which fewer than 33% of patients experienced dose limiting toxicity (DLT) attributable to the study drug(s), when at least six patients were treated at that dose and are evaluable for toxicity. A DLT will be defined as any of the following deemed to be related to study drug(s): * Grade 3 non-hematologic toxicity except alopecia not reversible to Grade 2 or less within 96 hours * Any Grade 4 toxicity DLT will be based on the first cycle of treatment (first 21 days). Toxicity will be graded according to the NCI CTCAE version 3.0. To be evaluable for toxicity, a patient must receive at least 1 complete course of treatment or have experienced DLT.

  Every 3 weeks after dosing

Secondary Outcomes (3)

• Best overall response

  Every 3 cycles after dosing (length of one cycle is 21 days)

• Time to progression

  Every 3 cycles after dosing (length of one cycle is 21 days)

• Pharmacokinetic (PK) data for the combination of perifosine and capecitabine

  Up to cyle 5 no pharmacokinetic samples were obtained. Cycle 1/Day 11 until Cycle 4/Day 11: pharmacokinetic samples obtained 0.5, 1, 2, 4, 6 and 8 hours after dosing

Study Arms (1)

Perifosine +Capecitabine

EXPERIMENTAL

One cycle of therapy will be defined as 3 weeks (21 days). Perifosine 50 mg qd (Days 1-21) + Capecitabine 1000 mg/m2 BID (Days 1-14).

Drug: Perifosine; Drug: Capecitabine

Interventions

Perifosine DRUG

Perifosine 50 mg orally once a day (Days 1-21)

Also known as: D-21266, KRX-0401

Perifosine +Capecitabine

Capecitabine DRUG

Capecitabine 1000 mg/m2 orally twice per day (Days 1-14)

Also known as: Xeloda

Perifosine +Capecitabine

Eligibility Criteria

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

You may qualify if:

• Patients with 3rd line or \> metastatic colon cancer
• Patients must have received or not be candidates for regimens containing 5- FU, oxaliplatin, irinotecan, bevacizumab, and cetuximab or panitumumab
• No prior exposure to perifosine
• Adequate bone marrow, liver, and renal function
• Patients must have at least one measurable lesion
• Patients must agree to have extra blood drawn for PK analyses

You may not qualify if:

• Patients with prior exposure to perifosine.
• Patients receiving any other investigational agents or devices.
• History of allergic reactions attributed to compounds of similar chemical or biologic composition to perifosine (miltefosine or edelfosine).
• Patients with known dipyrimidine dehydrogenase (DPD) deficiency or prior severe reaction to 5-FU.
• Patients with known central nervous system CNS metastases.
• Patients with known HIV, Hepatitis B, or Hepatitis C seropositivity.
• Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection and psychiatric illness/social situations that would limit compliance with study requirements.
• Patients with a history of unstable or newly diagnosed angina pectoris, recent myocardial infarction (within 6 months of enrollment), or New York Heart Association class II-IV congestive heart failure.
• Female patients who are pregnant or lactating are ineligible.

Sponsors & Collaborators

• AEterna Zentaris: lead
• SCRI Development Innovations, LLC: collaborator

Related Publications (1)

• Journal of Oncology, 2010 ASCO Annual Meeting Abstracts. Vol. 28, No. 15_suppl (May 20Supplement), 2010:e14086

  RESULT

MeSH Terms

Conditions

Colonic Neoplasms

Interventions

perifosine; Capecitabine

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

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

Study Officials

• Johanna Bendell,, MD

  SCRI Development Innovations, LLC

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 9, 2010
• First Posted: January 13, 2010
• Study Start: October 1, 2009
• Primary Completion: May 1, 2011
• Study Completion: October 1, 2011
• Last Updated: June 28, 2018

Record last verified: 2011-11