NCT00004008

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started Jul 1999

Typical duration for phase_2 ovarian-cancer

Geographic Reach
1 country

4 active sites

Status
completed

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

July 1, 1999

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

November 1, 1999

Completed
3.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2003

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 8, 2003

Completed
Last Updated

June 26, 2013

Status Verified

November 1, 1999

First QC Date

November 1, 1999

Last Update Submit

June 25, 2013

Conditions

Ovarian Cancer

Keywords

stage I ovarian epithelial cancerstage II ovarian epithelial cancerstage III ovarian epithelial cancerstage IV ovarian epithelial cancerrecurrent ovarian epithelial cancer

Interventions

bryostatin 1DRUG

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (4)

Christie Hospital N.H.S. Trust

Manchester, England, M20 4BX, United Kingdom

Location

Oxford Radcliffe Hospital

Oxford, England, 0X3 9DU, United Kingdom

Location

Weston Park Hospital

Sheffield, England, S1O 2SJ, United Kingdom

Location

Royal Infirmary

Glasgow, Scotland, G4 0SF, United Kingdom

Location

MeSH Terms

Conditions

Ovarian NeoplasmsCarcinoma, Ovarian Epithelial

Interventions

bryostatin 1

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesEndocrine System DiseasesGonadal DisordersCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic Type

Study Officials

  • Gordon Jayson, MD

    The Christie NHS Foundation Trust

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 1, 1999

First Posted

May 8, 2003

Study Start

July 1, 1999

Study Completion

May 1, 2003

Last Updated

June 26, 2013

Record last verified: 1999-11

Locations

GB(4)