Clinical trial · Interventional
Study of Perifosine + Capecitabine for Colon Cancer Patients
A Phase I Study of Perifosine + Capecitabine for Patients With Advanced Colon Cancer
NCT01048580CI-TRIAL-00033512completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is a Phase I study of Perifosine + Capecitabine for patients with advanced colon cancer.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colon Cancer | Malignant Colon Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Capecitabine | Drug | Capecitabine | ALIAS |
| Perifosine | Drug | Perifosine | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Perifosine +Capecitabine
- description
- 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).
- interventionNames
- Drug: Perifosine
- Drug: Capecitabine
Primary outcomes (1)
- measure
- Safety and tolerability of the combination of perifosine and capecitabine (i.e., dose limiting toxicity)
- timeFrame
- Every 3 weeks after dosing
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Exclusion Criteria: * 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.
References
Publications (1)
- RESULTJournal of Oncology, 2010 ASCO Annual Meeting Abstracts. Vol. 28, No. 15_suppl (May 20Supplement), 2010:e14086