Phase I Trial of Docetaxel With Perifosine

NCT00399087 | Completed Phase 1

• 1 other identifier: Perifosine 105
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

Brief Summary

This is a study of the drug perifosine given in combination with docetaxel. Perifosine is an oral anti-cancer agent that has been used in more than 140 people. Docetaxel 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 docetaxel with or without a steroid called prednisone, 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)

• Safety

  3 years

Secondary Outcomes (1)

• Disease progression

  3 years

Study Arms (3)

Perifosine D1 + Docetaxel

EXPERIMENTAL

Drug: Perifosine; Drug: Docetaxel

Perifosine D1+ Docexatel+Prednisone

EXPERIMENTAL

Drug: Perifosine; Drug: Docetaxel; Drug: Prednisone

Perifosine+ D1,8 and 15+Docetaxel+Prednisone

EXPERIMENTAL

Drug: Perifosine; Drug: Docetaxel; Drug: Prednisone

Interventions

Perifosine DRUG

Perifosine oral administration

Perifosine D1 + Docetaxel; Perifosine D1+ Docexatel+Prednisone; Perifosine+ D1,8 and 15+Docetaxel+Prednisone

Docetaxel DRUG

IV administration

Perifosine D1 + Docetaxel; Perifosine D1+ Docexatel+Prednisone; Perifosine+ D1,8 and 15+Docetaxel+Prednisone

Prednisone DRUG

Oral administration

Perifosine D1+ Docexatel+Prednisone; Perifosine+ D1,8 and 15+Docetaxel+Prednisone

Eligibility Criteria

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

You may qualify if:

• Patients must have histologically or cytologically confirmed diagnosis of cancer for which treatment with single agent docetaxel would be an appropriate treatment option.
• At least 18 years of age.
• Patients may be currently receiving docetaxel using the schedule in the protocol, as long as the treating investigator has reasonable expectation that the patient will continue to receive docetaxel 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 in the protocol: leukocytes \>=4,000/microL, absolute neutrophil count \>=1,500/microL, platelets \>=100,000/microL, HCT \> 28%, total bilirubin \< 1.5 x upper limit of normal, AST (SGOT)/ALT (SGPT) \<=2.5 X institutional upper limit of normal, creatinine \<= 2.5 mg/dl
• 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 Polysorbate 80 (Tween 80).

Sponsors & Collaborators

• AEterna Zentaris: lead

Study Sites (1)

Investigative Site

Johnson City, Tennessee, 37604, United States

Location

Related Publications (1)

• Journal of Clinical Oncology, 2006 ASCO Annual Meeting Proceedings (Post-Meeting Edition). Vol 24, No 18S (June 20 Supplement), 2006: 13066

  RESULT

MeSH Terms

Conditions

Neoplasms

Interventions

perifosine; Docetaxel; Prednisone

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• 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, 2010
• Study Completion: January 1, 2011
• Last Updated: February 13, 2014

Record last verified: 2013-02

Locations

US (1)