Clinical trial · Interventional
Paclitaxel and Bryostatin 1 in Treating Patients With Metastatic Prostate Cancer
Phase II Study of Weekly Paclitaxel and Bryostatin-1 in Hormone Refractory Prostate Cancer
NCT00005028CI-TRIAL-00041444completedPhase 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)
Phase II trial to study the effectiveness of combining paclitaxel and bryostatin 1 in treating patients who have metastatic prostate cancer that has not responded to hormone therapy. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.
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 |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| bryostatin 1 | Drug | — | UNRESOLVED |
| paclitaxel | Drug | Paclitaxel | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Arm I
- description
- Patients receive paclitaxel IV over 1 hour on days 1, 8, and 15 and bryostatin 1 IV over 1 hour on days 2, 9, and 16. Treatment repeats every 4 weeks in the absence of disease progression or unacceptable toxicity.
- interventionNames
- Drug: bryostatin 1
- Drug: paclitaxel
Primary outcomes (0)
[]Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Histologically confirmed metastatic adenocarcinoma of the prostate that failed first- or second-line hormonal therapy (e.g., gonadal androgen suppression \[orchiectomy or luteinizing hormone-releasing hormone\] with or without antiandrogens)
* Failure on hormonal therapy is defined by 1 of the following criteria:
* Biochemical progression (after withdrawal of antiandrogens), documented by 3 rising PSA values, each value measured at least 2 weeks apart, with the last measurement being at least 25% of the nadir achieved while on hormonal therapy and with an increase in the absolute value by at least 5 ng/mL
* Measurable disease progression, defined by an increase in the sum of the products of the perpendicular diameters of any measurable lesion(s) by at least 25%
* Bone only progression allowed only with concurrent biochemical progression
* Castrate levels of testosterone (no greater than 50 ng/dL)
* No clinical signs/symptoms suggesting CNS metastases
PATIENT CHARACTERISTICS:
Age
* 18 and over
Performance status
* ECOG 0-1
Life expectancy
* More than 6 months
Hematopoietic
* WBC at least 3,000/mm\^3
* Absolute granulocyte count at least 1,500/mm\^3
* Platelet count at least 100,000/mm\^3
Hepatic
* Bilirubin no greater than 1.5 times upper limit of normal (ULN)
* AST/ALT no greater than 2.5 times ULN
Renal
* Creatinine no greater than 1.5 times ULN
* Calcium no greater than ULN
Cardiovascular
* No uncontrolled or severe cardiovascular disease
* No myocardial infarction within the past 6 months
* No congestive heart failure
* No angina pectoris
* No active thromboembolic events within the past 3 months (e.g., deep venous thrombosis or cerebrovascular accident)
Other
* No other serious medical or psychiatric illness
* No active infection
* No dementia or significantly altered mental status
* No prior or concurrent grade 1 or greater peripheral neuropathy
* No other prior or concurrent malignancy within the past 5 years except curatively treated nonmelanoma skin cancer
* HIV negative
* Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Chemotherapy
* No prior chemotherapy (including paclitaxel)
Endocrine therapy
* At least 4 weeks since prior steroids or megestrol
Radiotherapy
* At least 4 weeks since prior radiotherapy to bone lesions
Other
* No other concurrent investigational therapyReferences
Publications (0)
Data not yet available
No reference posted for this study.