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Clinical Trials/NL-OMON35076
NL-OMON35076
Withdrawn
Phase 2

Everolimus (RAD001, Afinitor®) and Cyclophosphamide in Castration and Docetaxel resistant Prostate Cancer, a proof of principle Phase II study. - Metronomic treatment of castration resistant prostate cancer

ederlands Kanker Instituut0 sites20 target enrollmentTBD
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Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Not specified
Sponsor
ederlands Kanker Instituut
Enrollment
20
Status
Withdrawn
Last Updated
last year
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
last year
Study Type
Interventional

Investigators

Sponsor
ederlands Kanker Instituut

Eligibility Criteria

Inclusion Criteria

  • •\- Prostate cancer diagnosis and a rising PSA under castrate serum testosterone levels (2 rises
  • •in a period of at least 3 months), PSA \> 10ng/ml.
  • •\- At least one prior cycle of Docetaxel treatment.
  • •\- ECOG performance status 0\-2\.
  • •\- Locally accessible prostate cancer for TRUS\-guided biopsies.
  • •\- Written informed consent.
  • •\- Laboratory requirements:
  • •a) Hematology:
  • •\* Hemoglobin \> 5 mmol/L
  • •\* Platelet count \* 100,000/\*L

Exclusion Criteria

  • •\- Small cell pathology.
  • •\- Allergy to Everolimus or cyclophosphamide or components of Afinitor ® or Endoxan ®.
  • •\- Co\-medication interfering with CYP3A4 activity.
  • •\- Gastrointestinal (GI) disease, condition, or symptoms that may significantly impair GI function
  • •and alter the absorption of Everolimus, including any of the following:
  • •o Ulcerative disease
  • •o Malabsorption syndrome
  • •\- Other active malignancy or malignancy at \* 30% risk for relapse after completion of therapy,
  • •except nonmelanoma skin cancer .
  • •\- Recent (within 2 weeks) surgery.

Outcomes

Primary Outcomes

Not specified

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