Clinical trial · Interventional
Biomarker Study for Sunitinib and Docetaxel in Prostate Cancer
Randomized, Controlled Biomarker Study Evaluating the Anti-angiogenic Activity of Sunitinib in Hormone Refractory Prostate Cancer Patients Treated by Docetaxel
NCT00795171CI-TRIAL-00003811unknownPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Docetaxel and sunitinib will be compared to docetaxel for their effect on CEC/CEP spikes induced by docetaxel in HRPC patients
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hormone Refractory Prostate Cancer | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Docetaxel | Drug | Docetaxel | ALIAS |
| Docetaxel * Sunitinib | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Docetaxel + Sunitinib
- description
- docetaxel 75mg/m2 day1 q 21d x 4 cycles, sunitinib 37.5mg/d day2 -day15 x 4 cycles
- interventionNames
- Drug: Docetaxel * Sunitinib
- type
- ACTIVE_COMPARATOR
- label
- Taxotere
- description
- docetaxel 75mg/m2 day1 q 21d x 4 cycles
- interventionNames
- Drug: Docetaxel
Primary outcomes (1)
- measure
- Primary: CEC/CEP spikes induced by MTD docetaxel in patients treated with docetaxel/sunitinib relative to docetaxel monotherapy
- timeFrame
- 12 weeks
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * WHO performance status of 0-2. * Histologically proven prostate adenocarcinoma. * All patients must have prostate adenocarcinoma that is unresponsive or refractory to androgen ablation with biochemical progression * Measurable and/or evaluable progressive disease, which is defined by one of the following three criteria: * 25% increase in bidimensionally measurable soft tissue metastases * Appearance of new metastatic lesions (proven by CT scan, X-ray or bone scan) * PSA level of at least 10ng/mL, with increases on at least 2 successive occasions at least 2 weeks apart * If the patient has been treated with antiandrogens, treatment must have been stopped at least 6 weeks prior to study randomization Exclusion Criteria: \- prior chemotherapy for prostate cancer
References
Publications (0)
Data not yet available
No reference posted for this study.