Status:
COMPLETED
Phase I Trial of Paclitaxel With Perifosine
Lead Sponsor:
AEterna Zentaris
Conditions:
Neoplasms
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
This is a study of the drug perifosine given in combination with paclitaxel. Perifosine is an oral anti-cancer agent that has been used in more than 140 people. Paclitaxel is a standard chemotherapy a...
Detailed Description
This is a phase 1, open-label trial of perifosine and paclitaxel administered either weekly or every 3 weeks in patients with malignancies for whom single agent paclitaxel is a reasonable treatment op...
Eligibility Criteria
Inclusion
- Histologically or cytologically confirmed diagnosis of cancer for which treatment with single agent paclitaxel would be an appropriate treatment option.
- At least 18 years of age.
- Patients can have received no more than two prior chemotherapy regimens for metastatic disease. Patients may be currently receiving paclitaxel using one of the schedules in the protocol, as long as the treating investigator has reasonable expectation that the patient will continue to receive paclitaxel for 2 or more additional cycles. The current regimen does not count towards the 2 regimens as long as the patient is not progressing on therapy.
- Patients must have a life expectancy of more than 3 months.
- Patients must have a performance status of 0 to 2 according to the ECOG criteria.
- Patients must have normal organ and marrow function as defined below: leukocytes \>= 4,000/microL, absolute neutrophil count \>= 1,500/microL, platelets \>= 100,000/microL, HCT \> 28%, total bilirubin \< 2 x upper limit of normal, AST (SGOT)/ALT (SGPT) \<= 2.5 X institutional upper limit of normal, creatinine \<= 2.5 mg/dl transaminase \< 2.5 times institution's upper normal limits
- Patients must have recovered from acute toxicity related to prior therapy, excluding alopecia, including surgery or radiotherapy.
- Patients must be able to ingest oral medications.
- Female patients who are pregnant or lactating are ineligible. All females of childbearing potential must have a negative serum pregnancy test within 72 hours of treatment. Men and women of childbearing potential must agree to employ adequate contraception to prevent pregnancy while on therapy and for four weeks after the completion of treatment.
- Patients must have ability to understand and the willingness to sign a written informed consent document.
Exclusion
- Patients may not be 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).
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection and psychiatric illness/social situations that would limit compliance with study requirements.
- HIV-positive patients receiving combination anti-retroviral therapy are excluded from the study because of possible pharmacokinetic interactions with perifosine.
- Patients with a history of unstable or newly diagnosed angina pectoris, recent myocardial infarction (within 6 months of enrollment) or New York Heart Assoc. class II-IV congestive heart failure.
- Patients with a history of hypersensitivity reaction to products containing a Chremophor EL.
Key Trial Info
Start Date :
November 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2011
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT00399126
Start Date
November 1 2004
End Date
October 1 2011
Last Update
February 13 2014
Active Locations (1)
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1
AOI Pharmaceuticals Investigative Site
Johnson City, Tennessee, United States, 37604