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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2012-02831 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| PHII-21 | Other Identifier | City of Hope | |
| T99-0039 | Other Identifier | CTEP | |
| N01CM17101 | U.S. NIH Grant/Contract | View source |
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Phase II trial to study the effectiveness of combining bryostatin 1 and cisplatin in treating patients who have advanced recurrent or residual ovarian epithelial, fallopian tube, or primary peritoneal cancer. 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.
PRIMARY OBJECTIVES:
I. To estimate the overall response rate and the complete response rate of patients with platinum-refractory ovarian cancer who are treated with infusional Bryostatin-1 given in combination with intravenous cisplatin.
II. To estimate the duration of response in these patients. III. To obtain tissue in order to evaluate the molecular determinants of apoptosis including: p53 status, WAF1/CIP1 gene expression prior to and directly after chemotherapy, bcl-2 gene expression in vivo, bcl-2/bax ratio, p21, and the extent of apoptosis determined by the TdT assay; and the molecular determinants of DNA damage and repair including: expression levels of ERCC1.
OUTLINE: This is a multicenter study.
Patients receive bryostatin 1 IV continuously over 72 hours immediately followed by cisplatin IV over 1 hour. Treatment continues every 3 weeks for a minimum of 2 courses in the absence of disease progression.
Patients are followed for survival.
PROJECTED ACCRUAL: A total of 18-32 patients will be accrued for this study within 2 years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment (bryostatin 1, cisplatin) | Experimental | Patients receive bryostatin 1 IV continuously over 72 hours immediately followed by cisplatin IV over 1 hour. Treatment continues every 3 weeks for a minimum of 2 courses in the absence of disease progression. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| bryostatin 1 | Drug | Given IV |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival | Time from first day of treatment to time of death due to any cause, assessed up to 9 years | |
| Progression-free survival | Time from first day of treatment to the first observation of disease progression or death due to any cause, assessed up to 9 years | |
| Time to progression | Time from first day of treatment to the first observation of disease progression or death due to disease, assessed up to 9 years |
| Measure | Description | Time Frame |
|---|---|---|
| Response rate (CR or PR) | Exact 95% confidence intervals will be calculated. | Up to 9 years |
| Time to treatment failure | Estimated using the product-limit method of Kaplan and Meier. |
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Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Robert Morgan | City of Hope Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| City of Hope | Duarte | California | 91010 | United States |
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| cisplatin | Drug | Given IV |
|
|
| laboratory biomarker analysis | Other | Correlative studies |
|
| Up to 9 years |
| Duration of response | Estimated using the product-limit method of Kaplan and Meier. | Up to 9 years |
| Incidence by severity and type of toxicity based on the National Cancer Institute (NCI) Common Toxicity Criteria v2.0 and NCI Myalgia Toxicity Grading Scale | Up to 9 years |
| Association between p53, p21, bcl-2, bax, bcl-2/bax, ERCC-1, and Tdt and tumor response to chemotherapy (CR/PR vs not) | Proportions and Fisher's exact test will be used. Medians, ranges, quartiles and the Wilcoxon two-sample test will be used. | Prior to initiation of chemotherapy |
| Association between p53, p21, bcl-2, bax, bcl-2/bax, ERCC-1, and Tdt and tumor response to chemotherapy (CR/PR vs not) | Proportions and Fisher's exact test will be used. Medians, ranges, quartiles and the Wilcoxon two-sample test will be used. | Day 5 of course 2 |
| ID | Term |
|---|---|
| D005185 | Fallopian Tube Neoplasms |
| D000077216 | Carcinoma, Ovarian Epithelial |
| ID | Term |
|---|---|
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005184 | Fallopian Tube Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D010051 | Ovarian Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
| D010049 | Ovarian Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
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| ID | Term |
|---|---|
| C046785 | bryostatin 1 |
| D054713 | Bryostatins |
| D002945 | Cisplatin |
| ID | Term |
|---|---|
| D000095702 | Polyether Toxins |
| D000095662 | Polyether Polyketides |
| D004988 | Ethers, Cyclic |
| D004987 | Ethers |
| D009930 | Organic Chemicals |
| D018942 | Macrolides |
| D061065 | Polyketides |
| D007783 | Lactones |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
| D008387 | Marine Toxins |
| D014118 | Toxins, Biological |
| D001685 | Biological Factors |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
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