Phase I Trial of Paclitaxel With Perifosine

NCT00399126 | Completed Phase 1

• 1 other identifier: Perifosine 104
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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 agent used in many types of cancer. This study is designed to determine the highest dose of perifosine that can be administered to people every day while they are receiving paclitaxel in one of two regimens, without severe or prolonged nausea, vomiting and diarrhea. This study starts with patients taking 50 mg/day and goes up to 150 mg/day.

Conditions

Neoplasms

Outcome Measures

Primary Outcomes (1)

• GI Toxicities

  3 months

Secondary Outcomes (2)

• Other toxicities

  3 months

• Disease progression

  12 months

Interventions

Perifosine DRUG

Perifosine oral dose

Paclitaxel DRUG

Paclitaxel IV

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• AEterna Zentaris: lead

Study Sites (1)

AOI Pharmaceuticals Investigative Site

Johnson City, Tennessee, 37604, United States

Location

Related Publications (1)

• 1) Journal of Clinical Oncology, 2006 ASCO Annual Meeting Proceedings (Post-Meeting Edition). Vol 24, No 18S (June 20 Supplement), 2006: 13134 2) Journal of Clinical Oncology, 2006 ASCO Annual Meeting Proceedings (Post-Meeting Edition). Vol 24, No 18S (June 20 Supplement), 2006: 13117

  RESULT

MeSH Terms

Conditions

Neoplasms

Interventions

perifosine; Paclitaxel

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 10, 2006
• First Posted: November 14, 2006
• Study Start: November 1, 2004
• Primary Completion: January 1, 2009
• Study Completion: October 1, 2011
• Last Updated: February 13, 2014

Record last verified: 2011-10

Locations

US (1)