15DOP: Phase I and pharmacological study of weekly ModraDoc006/r in combination with high-dose intensity-modulated radiation therapy in patients with high-risk early stage prostate cancer
- Conditions
- Prostate cancer10038364
- Registration Number
- NL-OMON55802
- Lead Sponsor
- Antoni van Leeuwenhoek Ziekenhuis
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 35
1. Histologically proven prostate cancer.
2. All eligible patients have hormone naïve non-metastatic radiographic node
positive (>4 nodes) high risk prostate cancer.
3. High risk prostate cancer will be defined as node positive with all of the
following primary tumour characteristics: Tumour stage >=cT2c and Gleason score
>=4+3, any PSA
4. Age above 18 years
5. No signs of metastatic disease on standard diagnostic scans.
6. Adequate haematological, renal and hepatic functions
7. WHO performance status of 0-2
8. For Phase 1A only: Able and willing to undergo blood sampling for PK and PD
analysis;
9. Life expectancy above 3 months allowing adequate follow up of toxicity
evaluation and antitumor activity;
10. Able and willing to swallow oral medication
11. Able and willing to give written informed consent
1. Any treatment with investigational drugs, chemotherapy or immunotherapy
within 30 days prior to receiving the first dose of investigational treatment;
Patients may be on ADT as long as this is has not been longer than 12 weeks
prior the start of the radiotherapy.
2. Patients who have had prior pelvic radiation therapy
3. Patients who have had prior treatment with taxanes
4. TURP within 3 months before start of the study
5. Patients who have had a prostatectomy.
6. Any contra-indication for MRI
7. Major difficulties for marker implantation
8. Unreliable contraceptive methods. Men enrolled in this trial must agree to
use a reliable contraceptive method throughout the study (adequate
contraceptive methods are: condom, sterilization)
9. Unresolved (> grade 1) toxicities of previous chemotherapy, excluding
alopecia.
10. Uncontrolled infectious disease or known Human Immunodeficiency Virus HIV-1
or HIV-2 type patients;
11. Patients with a known history of hepatitis B or C;
12. Bowel obstructions or motility disorders that may influence the resorption
of drugs as judged by the treating physician
13. Concomitant use of MDR and CYP3A modulating drugs such as Ca+- entry
blockers (verapamil, dihydropyridines), cyclosporine, quinidine, tamoxifen,
megestrol and grapefruit juice, concomitant use of HIV medications, other
protease inhibitors, (non) nucleoside analoga, or St. John*s wort.
14. Pre-existing neuropathy greater than NCI-CTCAE v4.03 grade 1.
15. Patients with known alcoholism, drug addiction and/or psychiatric of
physiological condition which in the opinion of the investigator would impair
study compliance; Evidence of any other disease, neurological or metabolic
dysfunction, physical examination finding or laboratory finding giving
reasonable suspicion of a disease or condition that contraindicates the use of
an investigational drug or puts the patient at high risk for treatment-related
complications.
16. Legal incapacity
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>To determine the maximum tolerated dose (MTD) of ModraDoc006/r (as ModraDoc006<br /><br>10 mg tablets in combination with one tablet of 100 mg ritonavir) that can<br /><br>safely be administered in a bi-daily weekly schedule in combination with<br /><br>high-dose intensity modulated radiation therapy and androgen-deprivation<br /><br>therapy (ADT) </p><br>
- Secondary Outcome Measures
Name Time Method