search
Back to results

Bryostatin 1 in Treating Patients With Ovarian Epithelial Cancer

Primary Purpose

Ovarian Cancer

Status
Completed
Phase
Phase 2
Locations
United Kingdom
Study Type
Interventional
Intervention
bryostatin 1
Sponsored by
University of Glasgow
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ovarian Cancer focused on measuring stage I ovarian epithelial cancer, stage II ovarian epithelial cancer, stage III ovarian epithelial cancer, stage IV ovarian epithelial cancer, recurrent ovarian epithelial cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

DISEASE CHARACTERISTICS: Histologically proven ovarian epithelial cancer Progressive disease during or after completion of at least one platinum based chemotherapy regimen Bidimensionally measurable disease At least 2 cm by x-ray, CT scan, or ultrasound No active, symptomatic brain metastases (e.g., cerebral edema and/or progressive tumor growth) PATIENT CHARACTERISTICS: Age: 18 and over Performance status: WHO 0-2 Life expectancy: At least 12 weeks Hematopoietic: Hemoglobin at least 10 g/dL WBC at least 4,000/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 1.7 mg/dL AST/ALT no greater than 2.5 times upper limit of normal (ULN) (no greater than 5 times ULN if liver metastases present) Renal: Creatinine no greater than 1.4 mg/dL Other: No active, uncontrolled infection No nonmalignant systemic disease which would increase risk to patient No other malignancies within the past 5 years except curatively treated basal or squamous cell skin cancer or carcinoma in situ of the cervix Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception during and for 2 months after study PRIOR CONCURRENT THERAPY: Biologic therapy: At least 4 weeks since prior immunotherapy and recovered Chemotherapy: See Disease Characteristics At least 4 weeks since prior chemotherapy (6 weeks since nitrosoureas or mitomycin) and recovered No more than 2 prior multidrug chemotherapy regimens No more than 1 prior single agent chemotherapy regimen Endocrine therapy: At least 4 weeks since prior endocrine therapy and recovered No concurrent steroids Concurrent hormone replacement therapy allowed Radiotherapy: At least 4 weeks since prior radiotherapy (excluding palliative therapy) and recovered No concurrent radiotherapy Surgery: At least 4 weeks since prior major thoracic or abdominal surgery Other: No other concurrent anticancer therapy or investigational drugs

Sites / Locations

  • Christie Hospital N.H.S. Trust
  • Oxford Radcliffe Hospital
  • Weston Park Hospital
  • Royal Infirmary

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 1, 1999
Last Updated
June 25, 2013
Sponsor
University of Glasgow
search

1. Study Identification

Unique Protocol Identification Number
NCT00004008
Brief Title
Bryostatin 1 in Treating Patients With Ovarian Epithelial Cancer
Official Title
A Phase II Trial of Bryostatin 1 in Ovarian Cancer Administered by Weekly 24 Hour Intravenous Infusion
Study Type
Interventional

2. Study Status

Record Verification Date
November 1999
Overall Recruitment Status
Completed
Study Start Date
July 1999 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
May 2003 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University of Glasgow

4. Oversight

5. Study Description

Brief Summary
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of bryostatin 1 in treating patients who have ovarian epithelial cancer that has not responded to previous chemotherapy.
Detailed Description
OBJECTIVES: Evaluate the antitumor activity and toxicity of bryostatin 1 in patients with platinum resistant ovarian epithelial cancer. Determine the response rate in patients treated with this regimen. OUTLINE: This is a multicenter study. Patients receive bryostatin 1 IV over 24 hours. Treatment repeats weekly for 8 courses in the absence of disease progression or unacceptable toxicity. Patients achieving stable or regressive disease may receive additional treatment. Patients are followed for at least 4 weeks after treatment, then every 3 months. PROJECTED ACCRUAL: A total of 14-25 patients will be accrued for this study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ovarian Cancer
Keywords
stage I ovarian epithelial cancer, stage II ovarian epithelial cancer, stage III ovarian epithelial cancer, stage IV ovarian epithelial cancer, recurrent ovarian epithelial cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
bryostatin 1

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically proven ovarian epithelial cancer Progressive disease during or after completion of at least one platinum based chemotherapy regimen Bidimensionally measurable disease At least 2 cm by x-ray, CT scan, or ultrasound No active, symptomatic brain metastases (e.g., cerebral edema and/or progressive tumor growth) PATIENT CHARACTERISTICS: Age: 18 and over Performance status: WHO 0-2 Life expectancy: At least 12 weeks Hematopoietic: Hemoglobin at least 10 g/dL WBC at least 4,000/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 1.7 mg/dL AST/ALT no greater than 2.5 times upper limit of normal (ULN) (no greater than 5 times ULN if liver metastases present) Renal: Creatinine no greater than 1.4 mg/dL Other: No active, uncontrolled infection No nonmalignant systemic disease which would increase risk to patient No other malignancies within the past 5 years except curatively treated basal or squamous cell skin cancer or carcinoma in situ of the cervix Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception during and for 2 months after study PRIOR CONCURRENT THERAPY: Biologic therapy: At least 4 weeks since prior immunotherapy and recovered Chemotherapy: See Disease Characteristics At least 4 weeks since prior chemotherapy (6 weeks since nitrosoureas or mitomycin) and recovered No more than 2 prior multidrug chemotherapy regimens No more than 1 prior single agent chemotherapy regimen Endocrine therapy: At least 4 weeks since prior endocrine therapy and recovered No concurrent steroids Concurrent hormone replacement therapy allowed Radiotherapy: At least 4 weeks since prior radiotherapy (excluding palliative therapy) and recovered No concurrent radiotherapy Surgery: At least 4 weeks since prior major thoracic or abdominal surgery Other: No other concurrent anticancer therapy or investigational drugs
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gordon Jayson, MD
Organizational Affiliation
The Christie NHS Foundation Trust
Official's Role
Study Chair
Facility Information:
Facility Name
Christie Hospital N.H.S. Trust
City
Manchester
State/Province
England
ZIP/Postal Code
M20 4BX
Country
United Kingdom
Facility Name
Oxford Radcliffe Hospital
City
Oxford
State/Province
England
ZIP/Postal Code
0X3 9DU
Country
United Kingdom
Facility Name
Weston Park Hospital
City
Sheffield
State/Province
England
ZIP/Postal Code
S1O 2SJ
Country
United Kingdom
Facility Name
Royal Infirmary
City
Glasgow
State/Province
Scotland
ZIP/Postal Code
G4 0SF
Country
United Kingdom

12. IPD Sharing Statement

Learn more about this trial

Bryostatin 1 in Treating Patients With Ovarian Epithelial Cancer

We'll reach out to this number within 24 hrs