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Phase II Study of Perifosine for Patients With Metastatic Carcinoma of the Kidney Who Have Progressed on a VEGF Receptor Inhibitor

Phase 2
18 Years
Not Enrolling
Kidney Cancer

Thank you

Trial Information

Phase II Study of Perifosine for Patients With Metastatic Carcinoma of the Kidney Who Have Progressed on a VEGF Receptor Inhibitor

This is a Phase II study. Patients with kidney carcinoma will be considered in two groups.
Patients in group A will have previously failed a VEGF receptor inhibitor but not an mTOR
inhibitor, while patients in group B will have failed both a VEGF receptor inhibitor and an
mTOR inhibitor. Evaluation of each group will be performed separately. The goals of this
study are:

1. To measure clinical benefit defined as an objective tumor response using RESIST or
progression-free survival for more than 12 weeks in patients with metastatic carcinoma
of the kidney who have failed or have progressed on a VEGF receptor inhibitor

2. To evaluate the safety of perifosine in patients with metastatic carcinoma of the
kidney who have failed or have progressed on a VEGF receptor inhibitor.

Treatment Phase/duration of treatment: All patients will be treated with daily perifosine
at 100 mg PO daily until tumor progression (by the RECIST criteria) or unacceptable
toxicity. Once radiological disease progression has been documented by the treating
physician, the patient will go off study. Patients are encouraged to have two measurements
for confirmation of progression.

Follow-Up Phase: All patients will be followed-up for SAEs until at least 30 days after
discontinuation of perifosine. All patients who are discontinued from perifosine for any
reason other than disease progression will continue to have tumor assessments until the
patient has documented disease progression or has begun other therapies.

Inclusion Criteria:

- Patients with confirmed metastatic RCC

- Patients must have documented progression on treatment with sunitinib or sorafenib.
Prior therapy with bevacizumab and/or cytokines (i.e., IL-2, interferon) is
permitted. Prior vaccine therapy in the adjuvant setting is also permitted.
Patients can have failed therapy with ONE prior mTOR inhibitor.

- Patients must have at least one measurable lesion on computer tomography (CT) Scan or
magnetic resonance imaging (MRI) using Modified RECIST criteria.

- Patients must have normal organ and marrow function, unless in the opinion of the
treating investigator, the abnormality is related to tumor, and the study chairman
agree the abnormality is unlikely to affect the safety of perifosine use. Normal
organ and marrow function is described below:

- ANC >= 1.5 x 109/L

- Platelets >= 75,000/ mm3

- HCT >= 28% (with or without growth factor support)

- Creatinine <= 3.0 mg/dl

- Total bilirubin <= 1.5 x upper limit of normal

- Transaminase <= 2.5 x upper limit of normal

- ECOG performance status of 0 or 1

- Patients with CNS metastases must be clinically stable for at least 2 months
following treatment with radiation therapy, surgery, or both; and be off
corticosteroids and anti-seizure medication.

- Patients with a life expectancy ≥6 months

- Age ≥18 years old

- Patients who give a written informed consent obtained according to local guidelines

- Women of childbearing potential must have had a negative serum or urine pregnancy
test 72 hours prior to the administration of the first study treatment.

Exclusion Criteria:

- Patients who have not recovered (<= grade 1) from adverse events from prior therapy
(excluding alopecia).

- Patients currently receiving sorafenib or sunitinib who have received either of these
within 2 weeks prior to study entry.

- Patients may have had prior sorafenib OR sunitinib BUT cannot have been treated with
both VEGF receptor inhibitors.

- Patients with a known hypersensitivity to perifosine or its excipients.

- Female patients who are pregnant or breast feeding, or adults of reproductive
potential who are not using effective birth control methods.

- Patients who are using other investigational agents or who had received
investigational drugs <= 4 weeks prior to study entry.

- Patients unwilling to or unable to comply with the protocol.

- Patients who have a history of another primary malignancy <= 5 years with the
exceptions of non melanomatous skin cancer and carcinoma in situ of the cervix.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Objective tumor response using RESIST OR progression-free survival

Outcome Time Frame:

12 weeks

Safety Issue:


Principal Investigator

Nicholas J Vogelzang, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Nevada Cancer Institute


United States: Food and Drug Administration

Study ID:

Perifosine 231



Start Date:

July 2007

Completion Date:

October 2011

Related Keywords:

  • Kidney Cancer
  • Kidney
  • perifosine
  • Progression on treatment with sunitinib or sorafenib
  • Carcinoma
  • Carcinoma, Renal Cell
  • Kidney Neoplasms



Investigative Site Nyack, New York  
Investigative Site Louisville, Kentucky  40202
Investigative Site Morristown, New Jersey  07962