Study of Perifosine + Capecitabine for Colon Cancer Patients
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|ClinicalTrials.gov Identifier: NCT01048580|
Recruitment Status : Completed
First Posted : January 13, 2010
Last Update Posted : June 28, 2018
|Condition or disease||Intervention/treatment||Phase|
|Colon Cancer||Drug: Perifosine Drug: Capecitabine||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase I Study of Perifosine + Capecitabine for Patients With Advanced Colon Cancer|
|Study Start Date :||October 2009|
|Actual Primary Completion Date :||May 2011|
|Actual Study Completion Date :||October 2011|
Experimental: Perifosine +Capecitabine
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).
Perifosine 50 mg orally once a day (Days 1-21)
Capecitabine 1000 mg/m2 orally twice per day (Days 1-14)
Other Name: Xeloda
- Safety and tolerability of the combination of perifosine and capecitabine (i.e., dose limiting toxicity) [ Time Frame: Every 3 weeks after dosing ]
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.
- Best overall response [ Time Frame: Every 3 cycles after dosing (length of one cycle is 21 days) ]
The best overall response is the best response recorded from the start of the treatment until disease progression/recurrence (taking as reference for progressive disease the smallest measurements recorded since the treatment started).
Response Evaluation Criteria in solid tumors (RECIST): Measurable disease is defined as the presence of at least one measurable lesion. Measurable lesions are lesions that can be accurately measured in at least one dimension and fit one of the following criteria:
- Longest diameter ≥ 20 mm using conventional techniques, or
- ≥ 10 mm with spiral CT scan.
- Time to progression [ Time Frame: Every 3 cycles after dosing (length of one cycle is 21 days) ]
This is the interval from the initiation of treatment to the time of documented, objective progression using the same methods of evaluation that were used at baseline.
In order for a patient to be regarded as having progressive disease, the following criteria must be met:
- The site of disease must have been evaluated either at baseline or while receiving study medication. Both evaluations must use the same methodology.
- PET scan results will not be used as evidence of either progression or response..
- Pharmacokinetic (PK) data for the combination of perifosine and capecitabine [ Time Frame: 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 ]PK data will also be evaluated from all enrolled patients. PK analyses will present peak plasma concentrations (Cmax) as well as Area under the plasma concentration verus time curve (AUC).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01048580
|Study Chair:||Johanna Bendell,, MD||SCRI Development Innovations, LLC|