Bryostatin 1 and Cisplatin in Treating Patients With Advanced Recurrent or Residual Ovarian Epithelial, Fallopian Tube, or Primary Peritoneal Cancer
NCT ID: NCT00006942
Last Updated: 2013-08-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
32 participants
INTERVENTIONAL
2000-10-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Treatment (bryostatin 1, cisplatin)
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.
bryostatin 1
Given IV
cisplatin
Given IV
laboratory biomarker analysis
Correlative studies
Interventions
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bryostatin 1
Given IV
cisplatin
Given IV
laboratory biomarker analysis
Correlative studies
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Eligible patients include patients with measurable disease who have progressed while on chemotherapeutic treatment, patients with biopsy-proven persistent, clinically-measurable disease with best response as stable at the completion of planned first-line therapy, patients with persistent or recurrent disease with rising CA-125 to levels at least twice normal; the CA-125 increase must be documented by two independent measurements; no patient may have received more than two prior regimens of chemotherapy including first-line treatment
* Patients must have a Karnofsky performance status of greater than or equal to 50% and an estimated survival of at least three months
* Measured or calculated clearance \>= 60 ml/min
* AGC \>= 1800/mm\^3
* Plts \>= 100,000/mm\^3
* Bilirubin =\< 1.5 mg/dl
* SGOT less than 2 x upper limit of normal
* Previous radiotherapy or chemotherapy must have been completed at least three weeks before treatment under this protocol
* Patients must have the ability to give voluntary informed consent and to comply with the treatment and required tests
* Because Bryostatin is of unknown teratogenic potential, women of childbearing potential must have a negative pregnancy test and must take adequate precautions to prevent pregnancy during treatment
* Patients with any non-malignant intercurrent illness (e.g. cardiovascular, pulmonary, or central nervous system disease) which is either poorly controlled with currently available treatment, or is of such severity that the investigators deem it unwise to enter the patient on protocol shall be ineligible
* Patients currently being treated for severe infection or who are recovering from major surgery are ineligible until recovery is deemed complete by the investigator
* The extent of all evaluable and nonevaluable disease must be documented; pretreatment radiographic examinations should be done no earlier than 4 weeks (28 days) prior to the first course of chemotherapy; pre-treatment chemistries and CA-125 levels should be done no earlier than two weeks (14 days) prior to initiation of chemotherapy; (in calculating days of tests and measurements, the day a test or measurement is done is considered day 0; therefore, if a test is done on Monday, the Monday four weeks later would be considered day 28; this allows for efficient patient scheduling without exceeding the guidelines)
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Responsible Party
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Principal Investigators
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Robert Morgan
Role: PRINCIPAL_INVESTIGATOR
City of Hope Medical Center
Locations
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City of Hope
Duarte, California, United States
Countries
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Other Identifiers
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NCI-2012-02831
Identifier Type: REGISTRY
Identifier Source: secondary_id
PHII-21
Identifier Type: OTHER
Identifier Source: secondary_id
T99-0039
Identifier Type: OTHER
Identifier Source: secondary_id
NCI-2012-02831
Identifier Type: -
Identifier Source: org_study_id