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Docetaxel, Thalidomide, Prednisone, and Bevacizumab to Treat Metastatic Prostate Cancer
Phase 2 trial testing Docetaxel in Prostatic Neoplasms in 73 participants. Completed in 9 January 2018.
| Lead sponsor | National Cancer Institute (NCI) |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 73 |
| Start date | 19 April 2005 |
| Primary completion | 31 December 2011 |
| Estimated completion | 9 January 2018 |
| Sites | 1 location across United States |
National Cancer Institute (NCI)
18 and older, male only, with Prostatic Neoplasms. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
PSA response was assessed by the PSA Consensus Criteria. PSA decline is defined as a decline in PSA of at least 50% with no other evidence of disease progression.
| Group | Value | 95% CI |
|---|---|---|
| Main Cohort - Prostate Cancer | 52 |
Here is the number of participants with adverse events. For a detailed list of adverse events see the adverse event module.
| Group | Value | 95% CI |
|---|---|---|
| Main Cohort - Prostate Cancer | 60 | |
| Expansion Cohort - Prostate Cancer | 13 |
Time to disease progression was based on the Prostate-Specific Antigen (PSA) Working Group 1 Criteria (Bubley Criteria) and standard Response Evaluation Criteria in Solid Tumors (RECIST) for measurable disease. Per the criteria, investigators report at a minimum a PSA decline of at least 50% and this must be confirmed by a second PSA value 4 or more weeks later. Patients may not demonstrate clinical or radiographic evidence of disease progression during this time period.
| Group | Value | 95% CI |
|---|---|---|
| Main Cohort - Prostate Cancer | 18.3 | 0 – 40 |
Clinical and radiographic response was measured by the Response Evaluation Criteria in Solid Tumors (RECIST) Criteria. Complete response (CR) is disappearance of all target lesions. Partial response (PR) is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions. taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. Stable disease (SD) is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking s reference the smallest sum LD since the treatment started. Progre
| Group | Value | 95% CI |
|---|---|---|
| Main Cohort - Prostate Cancer | 2 |
| Group | Value | 95% CI |
|---|---|---|
| Main Cohort - Prostate Cancer | 19 |
| Group | Value | 95% CI |
|---|---|---|
| Main Cohort - Prostate Cancer | 11 |
| Group | Value | 95% CI |
|---|---|---|
| Main Cohort - Prostate Cancer | 1 |
From on study date to date of death at 34 months.
| Group | Value | 95% CI |
|---|---|---|
| Main Cohort - Prostate Cancer | 38 |
The assay utilized has no standard curve. Categorizing patients with ≥ 75% PSA decline in one group and \< PSA decline in another group, every patient is their own control with comparison of CAEC at baseline vs. 6 weeks (after two cycles of treatment). Blood is drawn from the patient and a million viable mononuclear cells are counted and then it is determined how many CAECs are in the specimen. The cell count is then compared from baseline to post 2 cycles of treatment. Thus, "significant increase" is dependent upon this comparison and varies between patients.
| Group | Value | 95% CI |
|---|---|---|
| Main Cohort - Particpants With ≥75% PSA Decline | 14 | |
| Main Cohort - Particpants With <75% PSA Decline | 0 |
Time frame: 37 months. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Main Cohort - Prostate Can… | Expansion Cohort - Prostat… |
|---|---|---|---|
| Death not associated with CTCAE term: Death Progression NOS | General disorders | — | — |
| Death not associated with CTCAE term::Death NOS | General disorders | — | — |
| Infection with normal ANC or Grade 1 or 2 neutrophils::Lung (pneumonia) | Infections and infestations | — | — |
| Neutrophils/granulocytes (ANC/AG) | Blood and lymphatic system disorders | — | — |
| Hemoglobin | Metabolism and nutrition disorders | — | — |
| Thrombosis/thrombus/embolism | Vascular disorders | — | — |
| CNS cerebrovascular ischemia | Nervous system disorders | — | — |
| Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10e9/L) | General disorders | — | — |
| Hypertension | Cardiac disorders | — | — |
| Hypotension | Cardiac disorders | — | — |
| Supraventricular and nodal arrhythmia::Atrial fibrillation | Cardiac disorders | — | — |
| Syncope (fainting) | Nervous system disorders | — | — |
| ALT, SGPT (serum glutamic pyruvic transaminase) | Metabolism and nutrition disorders | — | — |
| AST, SGOT(serum glutamic oxaloacetic transaminase) | Metabolism and nutrition disorders | — | — |
| Allergic reaction/hypersensitivity (including drug fever) | Immune system disorders | — | — |
| Aspiration | Respiratory, thoracic and mediastinal disorders | — | — |
| CPK (creatine phosphokinase) | Metabolism and nutrition disorders | — | — |
| Cardiac arrhythmia - Other, Specify, new onset of A. fib | Cardiac disorders | — | — |
| Cardiac general - Other, Specify, aortic dissection | Cardiac disorders | — | — |
| Dehydration | Gastrointestinal disorders | — | — |
| Fatigue (asthenia, lethargy, malaise) | General disorders | — | — |
| Febrile neutropenia | Infections and infestations | — | — |
| Fracture | Injury, poisoning and procedural complications | — | — |
| Hemorrhage, GI: Abdomen NOS | Gastrointestinal disorders | — | — |
| Hemorrhage, GI: Colon | Gastrointestinal disorders | — | — |
| Reaction | System | Main Cohort - Prostate Can… | Expansion Cohort - Prostat… |
|---|---|---|---|
| Fatigue (asthenia, lethargy, malaise) | General disorders | — | — |
| Constipation | Gastrointestinal disorders | — | — |
| Neuropathy: sensory | Nervous system disorders | — | — |
| Albumin, serum-low (hypoalbuminemia) | Metabolism and nutrition disorders | — | — |
| Lymphopenia | Blood and lymphatic system disorders | — | — |
| Leukocytes (total WBC) | Blood and lymphatic system disorders | — | — |
| Neutrophils/granulocytes (ANC/AGC) | Blood and lymphatic system disorders | — | — |
| Hemoglobin | Metabolism and nutrition disorders | — | — |
| Taste alteration (dysgeusia) | Gastrointestinal disorders | — | — |
| Hair loss/alopecia (scalp or body) | Skin and subcutaneous tissue disorders | — | — |
| Nail changes | Skin and subcutaneous tissue disorders | — | — |
| Dyspnea (shortness of breath) | Respiratory, thoracic and mediastinal disorders | — | — |
| Watery eye (epiphora, tearing) | Eye disorders | — | — |
| Nasal cavity/paranasal sinus reactions | Respiratory, thoracic and mediastinal disorders | — | — |
| Phosphate, serum-low (hypophosphatemia) | Metabolism and nutrition disorders | — | — |
| Calcium, serum-low (hypocalcemia) | Metabolism and nutrition disorders | — | — |
| Dry mouth/salivary gland (xerostomia) | Gastrointestinal disorders | — | — |
| Diarrhea | Gastrointestinal disorders | — | — |
| Hemorrhage, pulmonary/upper respiratory: Nose | Respiratory, thoracic and mediastinal disorders | — | — |
| Dizziness | Nervous system disorders | — | — |
| Hypertension | Cardiac disorders | — | — |
| Potassium, serum-high (hyperkalemia) | Metabolism and nutrition disorders | — | — |
| ALT, SGPT (serum glutamic pyruvic transaminase) | Metabolism and nutrition disorders | — | — |
| AST, SGOT(serum glutamic oxaloacetic transaminase) | Metabolism and nutrition disorders | — | — |
| Pleural effusion (non-malignant) | Respiratory, thoracic and mediastinal disorders | — | — |
| Edema: limb | Blood and lymphatic system disorders | — | — |
| Febrile Neutropenia | Infections and infestations | — | — |
| Pain-Other (Specify,R leg pain; shoulder pain; tooth pain; jaw) | General disorders | — | — |
| Platelets | Blood and lymphatic system disorders | — | — |
| Rash/desquamation | Skin and subcutaneous tissue disorders | — | — |
| Voice changes/dysarthria (e.g., hoarseness, loss or alteration in voice, laryngitis) | Respiratory, thoracic and mediastinal disorders | — | — |
| Alkaline phosphatase | Metabolism and nutrition disorders | — | — |
| Dry skin | Skin and subcutaneous tissue disorders | — | — |
| PTT (Partial Thromboplastin Time) | Blood and lymphatic system disorders | — | — |
| Osteonecrosis (avascular necrosis) | Musculoskeletal and connective tissue disorders | — | — |
| Pain: Back | Musculoskeletal and connective tissue disorders | — | — |
| Rash: hand-foot skin reaction | Skin and subcutaneous tissue disorders | — | — |
| Cough | Respiratory, thoracic and mediastinal disorders | — | — |
| Neurology-Other (Specify,______) | Nervous system disorders | — | — |
| Proteinuria | Metabolism and nutrition disorders | — | — |
Most-reported serious reactions: Death not associated with CTCAE term: Death Progression NOS, Death not associated with CTCAE term::Death NOS, Infection with normal ANC or Grade 1 or 2 neutrophils::Lung (pneumonia), Neutrophils/granulocytes (ANC/AG), Hemoglobin, Thrombosis/thrombus/embolism, CNS cerebrovascular ischemia, Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10e9/L).
Data from ClinicalTrials.gov NCT00089609 adverse events section.
This is a Phase II study of docetaxel, bevacizumab, prednisone and thalidomide in patients with androgen independent metastatic prostate cancer who are previously untreated with chemotherapy. The primary objective of this study is to determine if the combination of docetaxel, thalidomide and bevacizumab is able to be associated with a sufficiently high proportion of patients with a prostate-specific antigen (PSA) response to be worthy of further investigation in metastatic prostate cancer. We will also be looking at multiple secondary endpoints. These will include possible pharmacokinetic interactions among the study agents, potential correlation between patient genotype and efficacy of treatment. We will also be looking for circulating tumor cells in blood before and after treatment. Additionally we will be monitoring the tolerability of the regimen and survival duration as endpoints as well. We hope to use this trial to build on the promising results seen in our thalidomide/docetaxel protocol where there was a significant PSA decline and a trend toward survival benefit.
5 peer-reviewed publications reference this trial (live from Europe PMC):
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