Bryostatin 1 and Cisplatin in Treating Patients With Advanced Recurrent or Residual Ovarian Epithelial, Fallopian Tube, or Primary Peritoneal Cancer
A Phase II Trial of Bryostatin in Combination With Cisplatin in Patients With Recurrent or Persistent Epithelial Ovarian Cancer
4 other identifiers
interventional
32
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2000
CompletedFirst Submitted
Initial submission to the registry
December 6, 2000
CompletedFirst Posted
Study publicly available on registry
January 27, 2003
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2004
CompletedAugust 26, 2013
August 1, 2013
3.4 years
December 6, 2000
August 23, 2013
Conditions
Outcome Measures
Primary Outcomes (3)
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
Secondary Outcomes (6)
Response rate (CR or PR)
Up to 9 years
Time to treatment failure
Up to 9 years
Duration of response
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)
Prior to initiation of chemotherapy
- +1 more secondary outcomes
Study Arms (1)
Treatment (bryostatin 1, cisplatin)
EXPERIMENTALPatients 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.
Interventions
Given IV
Eligibility Criteria
You may qualify if:
- Advanced recurrent or residual ovarian, fallopian tube, or papillary primary peritoneal cancer which has been histologically confirmed
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
City of Hope
Duarte, California, 91010, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Robert Morgan
City of Hope Medical Center
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 6, 2000
First Posted
January 27, 2003
Study Start
October 1, 2000
Primary Completion
March 1, 2004
Last Updated
August 26, 2013
Record last verified: 2013-08