Perifosine in Treating Patients With Recurrent Prostate Cancer

NCT00058214 | Terminated Phase 2 Results

• 4 other identifiers: NCI-2012-02832PHII-44N01CM17101CDR0000287195
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

Phase II trial to study the effectiveness of perifosine in treating patients who have recurrent prostate cancer. Drugs used in chemotherapy such as perifosine use different ways to stop tumor cells from dividing so they stop growing or die

Conditions

Adenocarcinoma of the Prostate; Recurrent Prostate Cancer; Stage IIB Prostate Cancer; Stage III Prostate Cancer; Stage IV Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• PSA Response

  A PSA normalization (PSA-N) - was recorded on case report forms for any evaluation in which the PSA level was undetectable (\< 0.1 ng/mL). If the PSA-N response was confirmed by a second measurement ≥ 4 weeks later, the patient's best PSA response was considered PSA-N. PSA-PR was recorded if the PSA decreased by ≥ 50% from baseline (pretreatment) values and confirmed by a second measurement ≥ 4 weeks later. PSA-PD was recorded upon the appearance of ≥ 1 new lesion on radiographs consistent with metastatic disease, an absolute increase in PSA value of 5 ng/mL relative to the lowest postenrollment PSA value (including the baseline PSA value), or if the PSA doubling time was \< 2 months. PSA-SD constituted responses that did not qualify for PSA-N, PSA-PR, or PSA-PD. Response = PSA-N + PSA-PR.

  Up to 6 years

Secondary Outcomes (1)

• Time to Progression

  From the date of registration to the date of documented PSA progression, assessed up to 6 years

Study Arms (1)

Treatment (perifosine)

EXPERIMENTAL

Patients receive oral perifosine once daily on days 1-28. On day 1 of course 1 only, patients receive 2 doses of oral perifosine. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients with progressive disease by PSA alone may receive up to 3 additional courses of therapy after documentation of progression.

Drug: perifosine; Other: laboratory biomarker analysis

Interventions

perifosine DRUG

Given orally

Also known as: D21266, octadecylphosphopiperidine

Treatment (perifosine)

laboratory biomarker analysis OTHER

Correlative studies

Treatment (perifosine)

Eligibility Criteria

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

You may qualify if:

• Patients must have histologically or cytologically confirmed adenocarcinoma of the prostate
• Patients must have a rising PSA \>= 2.0 following a nadir after local curative therapy (either radical prostatectomy and/or pelvic radiation) with no clinical or radiographic evidence of metastatic disease; PSA \>= 2.0 elevation must be confirmed by two consecutive increases, each measured at least 2 weeks apart; only patients with a biochemical (PSA) recurrence with no physical exam or radiographic evidence of local or distant relapse are eligible
• Prior hormonal therapy in the form of neoadjuvant or adjuvant therapy is allowed as long as neither lasted for more than 9 months; androgen deprivation therapy must have been completed at least one year prior to registration; patients could not have had a rising PSA at the time that neoadjuvant or adjuvant therapy was stopped
• Life expectancy of greater than 3 months
• Karnofsky performance status \> 60%
• Leukocytes \>= 3,000/uL
• Absolute neutrophil count \>= 1,500/uL
• Platelets \>= 100,00/uL
• Total bilirubin =\< 1.5 mg/dL
• AST (SGOT)/ALT (SGPT) =\< 2.5 x institutional upper limit of normal
• Creatinine within normal institutional limits OR creatinine clearance \>= 60 mL/min
• Computed tomography scan or MRI of the pelvis negative for metastatic disease within 3 months prior to registration
• Bone scan negative for metastatic disease within 3 months prior to registration
• Chest PA and lateral films negative for metastatic disease within 3 months prior to registration
• Prior vaccine therapy is allowed if completed at least 6 months prior to registration

You may not qualify if:

• Patients who have had any prior cytotoxic chemotherapy
• Patients may not be receiving any other investigational agents
• Patients receiving concurrent chemotherapeutic agents, biological response modifiers, radiation therapy, corticosteroid or hormonal therapy; no complementary or alternative therapy (e.g., St. John's Wort, PC-SPES, or any other herbal remedies taken for the purpose of treating prostate cancer) may be given during protocol treatment
• History of allergic reactions attributed to compounds of similar chemical or biologic composition to perifosine
• Androgen deprivation given for reasons other than neoadjuvant or adjuvant therapy
• Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or 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; appropriate studies will be undertaken in patients receiving combination anti-retroviral therapy when indicated
• No prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, in situ carcinoma of any site, adequately treated stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease-free for 5 years

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

UC Davis Cancer Center

Sacramento, California, 95817, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

perifosine; octadecyl-(N,N-dimethylpiperidino-4-yl)-phosphate

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Limitations and Caveats

Study was terminated early after the first stage of a two-stage design, allowing for early termination for discouraging results.

Results Point of Contact

• Title: DCC Project Administrator
• Organization: California Cancer Consortium

CCCP@coh.org

626-256-4673

Study Officials

• Primo Lara, MD

  University of California, Davis

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 7, 2003
• First Posted: April 9, 2003
• Study Start: March 1, 2003
• Primary Completion: January 1, 2009
• Study Completion: January 1, 2009
• Last Updated: February 23, 2015
• Results First Posted: February 23, 2015

Record last verified: 2013-02

Locations

US (1)