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A Phase II Trial of Bryostatin in Combination With Cisplatin in Patients With Recurrent or Persistent Epithelial Ovarian Cancer

Phase 2
18 Years
Not Enrolling
Fallopian Tube Cancer, Primary Peritoneal Cavity Cancer, Recurrent Ovarian Epithelial Cancer, Stage III Ovarian Epithelial Cancer, Stage IV Ovarian Epithelial Cancer

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Trial Information

A Phase II Trial of Bryostatin in Combination With Cisplatin in Patients With Recurrent or Persistent Epithelial Ovarian Cancer


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.

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)

Type of Study:


Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall survival

Outcome Time Frame:

Time from first day of treatment to time of death due to any cause, assessed up to 9 years

Safety Issue:


Principal Investigator

Robert Morgan

Investigator Role:

Principal Investigator

Investigator Affiliation:

Beckman Research Institute


United States: Food and Drug Administration

Study ID:




Start Date:

October 2000

Completion Date:

Related Keywords:

  • Fallopian Tube Cancer
  • Primary Peritoneal Cavity Cancer
  • Recurrent Ovarian Epithelial Cancer
  • Stage III Ovarian Epithelial Cancer
  • Stage IV Ovarian Epithelial Cancer
  • Peritoneal Neoplasms
  • Fallopian Tube Neoplasms
  • Neoplasms, Glandular and Epithelial
  • Ovarian Neoplasms



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