Status:
COMPLETED
Phase I Perifosine and Gemcitabine Study
Lead Sponsor:
AEterna Zentaris
Conditions:
Neoplasms
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
This is a study of the drug perifosine in combination with Gemcitabine. Perifosine is an oral anti-cancer agent that has been used in more than 140 people, but has not been combined with other drugs b...
Detailed Description
This is a phase 1, open-label trial of perifosine and gemcitabine in patients with malignancies for whom single agent gemcitabine is a reasonable treatment option. All patients will receive gemcitabin...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- Patients must have histologically or cytologically confirmed diagnosis of cancer for which treatment with single agent gemcitabine would be an appropriate treatment option
- At least 18 years of age
- Patients may have received no more than two prior chemotherapy regimens
- 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 in the protocol.
- Patients must have recovered from any acute toxicity related to prior therapy, 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.
- Patients must have ability to understand and the willingness to sign a written informed consent document.
- Exclusion Criteria
- 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. HIV-positive patients not receiving combination anti-retroviral therapy must be approved by the study chair prior to entry.
- 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.
- Radiation therapy to \> 50% of marrow producing sites.
Exclusion
Key Trial Info
Start Date :
August 1 2004
Trial Type :
INTERVENTIONAL
End Date :
January 1 2006
Estimated Enrollment :
19 Patients enrolled
Trial Details
Trial ID
NCT00398697
Start Date
August 1 2004
End Date
January 1 2006
Last Update
February 13 2014
Active Locations (1)
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1
Johnson City, Tennessee, United States, 37604