Oral Docetaxel (ModraDoc/r) in Combination With Hormonal Treatment and Radiation Therapy in High-risk Prostate Cancer (DOP)
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|ClinicalTrials.gov Identifier: NCT03066154|
Recruitment Status : Recruiting
First Posted : February 28, 2017
Last Update Posted : February 28, 2017
The optimal treatment for HRPC patients has not yet been established. Recent trials suggest a benefit from early treatment with docetaxel in the castration-sensitive setting, with an improvement in failure free survival in high risk and metastatic patients and increase in overall survival in the metastatic hormone-sensitive group. In these recent randomized controlled trials, patients were treated with hormonal therapy and radiotherapy and adjuvant docetaxel, assuming that early systemic treatment for high risk or metastatic disease could delay progression in patients with aggressive primary tumor characteristics.
With the fact that docetaxel is a known radiosensitizer, combined modality treatment with docetaxel during the radiotherapy could also lead to better local control and reduction of local recurrence. Several phase I and II studies have been done in HRPC patients, to evaluate the combination of high dose radiotherapy and concurrent weekly infusions with docetaxel.
Oral administration of docetaxel has many advantages above intravenously administered drugs for patients. Besides the higher patient convenience, possibly longer treatment duration can be achieved due to better safety. Frequently occurring toxicities of intravenously administered docetaxel, such as neutropenia, hypersensitivity reactions and peripheral polyneuropathy have rarely been observed with the oral docetaxel formulation ModraDoc006/r.
The primary aim of the N15DOP study is to determine the maximum tolerable dose (MTD) of ModraDoc006/r when given in a weekly bidaily schedule in combined modality with high dose intensity radiotherapy and hormonal therapy in castration-sensitive prostate cancer patients with high risk disease, including positive lymph nodes.
|Condition or disease||Intervention/treatment||Phase|
|Prostatic Neoplasms||Drug: oral docetaxel (ModraDoc/r) Drug: androgen deprivation therapy Radiation: high-dose intensity-modulated radiation therapy||Phase 1|
Phase IA part This is an open-label, dose-escalating, non-randomized, single centre phase I study of ModraDoc006/r combined with ADT and radiotherapy in patients with high risk prostate cancer, as defined by node positive prostate cancer with all of the following primary tumor characteristics: stage ≥cT2c, Gleason score ≥ 4+3, any PSA level.
Phase IB part After determination of the MTD of ModraDoc006/r in the combined treatment with radiotherapy and hormonal therapy and good tolerability of the treatment without unexpected adverse events during the radiotherapy until 6 weeks after the end of radiotherapy, the study will be further conducted to the phase IB part. This part will explore the feasibility and tolerability of long term treatment with ModraDoc006/r.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||24 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Weekly ModraDoc/r in Combination With Hormonal Treatment and High-dose Intensity-modulated Radiation Therapy in Patients With High-risk Early Stage Prostate Cancer|
|Study Start Date :||September 2016|
|Estimated Primary Completion Date :||September 2019|
|Estimated Study Completion Date :||January 2020|
Chemoradiation with ModraDoc/r and radiotherapy of the prostate in dose escalation design, followed by maintenance treatment.
Drug: oral docetaxel (ModraDoc/r)
Weekly once- or twice daily ModraDoc/r
Other Name: ModraDoc006/ritonavir
Drug: androgen deprivation therapy
ADT according to the standard of care
Other Name: hormonal therapy
Radiation: high-dose intensity-modulated radiation therapy
77 Gy in 35 fractions of 2.2 Gy, 5 fractions a week
Other Name: radiotherapy
- Maximal tolerated dose (MTD) of ModraDoc/r in the combination treatment [ Time Frame: 12 months ]MTD of ModraDoc006/r (as ModraDoc006 10 mg tablets in combination with one tablet of 100 mg ritonavir) that can safely be administered in a bi-daily weekly schedule in combination with high-dose intensity modulated radiation therapy and androgen-deprivation therapy
- Number of participants with treatment-related adverse events as assessed by CTCAE v.4.03 with treatment with ModraDoc006/r in combination with ADT and high dose radiotherapy [ Time Frame: 12 months ]
- Number of patients that will have recurrence of prostate cancer after completion of the study treatment [ Time Frame: 10 years ]
- To determine the Peak Plasma Concentration (Cmax) of docetaxel in this regime. [ Time Frame: 12 months ]
- To determine the "Area under the plasma concentration versus time curve (AUC) of docetaxel in this regime. [ Time Frame: 12 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03066154
|Contact: B van Triest, MD, PhDemail@example.com|
|Contact: M Vermunt, MDfirstname.lastname@example.org|
|Netherlands Cancer Institute||Recruiting|
|Contact: B van Triest, MD, PhD 0205129111 email@example.com|
|Contact: M Vermunt, MD 0205122127 firstname.lastname@example.org|
|Principal Investigator:||B van Triest, MD, PhD||The Netherlands Cancer Institute|