Bryostatin 1 in Treating Patients With Ovarian Epithelial Cancer
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Ovarian Cancer |
Drug: bryostatin 1 |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Primary Purpose: Treatment |
| Official Title: | A Phase II Trial of Bryostatin 1 in Ovarian Cancer Administered by Weekly 24 Hour Intravenous Infusion |
| Study Start Date: | July 1999 |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| United Kingdom | |
| Christie Hospital N.H.S. Trust | |
| Manchester, England, United Kingdom, M20 4BX | |
| Oxford Radcliffe Hospital | |
| Oxford, England, United Kingdom, 0X3 9DU | |
| Weston Park Hospital | |
| Sheffield, England, United Kingdom, S1O 2SJ | |
| Royal Infirmary | |
| Glasgow, Scotland, United Kingdom, G4 0SF | |
| Study Chair: | Gordon Jayson, MD | Christie Hospital NHS Foundation Trust |
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00004008 History of Changes |
| Other Study ID Numbers: | CDR0000067219, CRC-PHASE-II-PH2/039, NCI-T99-0027 |
| Study First Received: | November 1, 1999 |
| Last Updated: | July 23, 2008 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Cancer Institute (NCI):
|
stage I ovarian epithelial cancer stage II ovarian epithelial cancer stage III ovarian epithelial cancer stage IV ovarian epithelial cancer recurrent ovarian epithelial cancer |
Additional relevant MeSH terms:
|
Ovarian Neoplasms Neoplasms, Glandular and Epithelial Endocrine Gland Neoplasms Neoplasms by Site Neoplasms Ovarian Diseases Adnexal Diseases Genital Diseases, Female Genital Neoplasms, Female Urogenital Neoplasms |
Endocrine System Diseases Gonadal Disorders Neoplasms by Histologic Type Bryostatin 1 Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Adjuvants, Immunologic Immunologic Factors Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on May 23, 2013