Brief Title
Bryostatin 1 and Cisplatin in Treating Patients With Advanced Recurrent or Residual Ovarian Epithelial, Fallopian Tube, or Primary Peritoneal Cancer
Official Title
A Phase II Trial of Bryostatin in Combination With Cisplatin in Patients With Recurrent or Persistent Epithelial Ovarian Cancer
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.
Detailed Description
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.
Study Phase
Phase 2
Study Type
Interventional
Primary Outcome
Overall survival
Secondary Outcome
Response rate (CR or PR)
Condition
Fallopian Tube Cancer
Intervention
bryostatin 1
Study Arms / Comparison Groups
Treatment (bryostatin 1, cisplatin)
Description: 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.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
32
Start Date
October 2000
Primary Completion Date
March 2004
Eligibility Criteria
Inclusion Criteria:
- 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)
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Robert Morgan, ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT00006942
Organization ID
NCI-2012-02831
Secondary IDs
NCI-2012-02831
Responsible Party
Sponsor
Study Sponsor
National Cancer Institute (NCI)
Study Sponsor
Robert Morgan, Principal Investigator, City of Hope Medical Center
Verification Date
August 2013