Phase I Perifosine and Gemcitabine Study

• Status: Completed
• Trial end date: 2006-01-01
• Target enrollment: 0
• Participant gender: All

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 before this study. The study is designed to determine the highest dose of perifosine that can be administered to people every day while they are on a Gemcitabine regimen, without severe or prolonged nausea, vomiting and diarrhea. This study starts with patients taking 50 mg/day and goes up to 150 mg/day. After the highest tolerable dose is found, we will add 10 more patients at that dose.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AEterna Zentaris
• Treatments: Gemcitabine

Criteria

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.