Expired Study
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New York, New York 10021


Purpose:

RATIONALE: Some tumors need growth factors produced by the body's white blood cells to keep growing. Goserelin may interfere with the growth factor and may stop the tumor from growing. Bicalutamide may prevent androgens from stimulating the growth of cancer cells. PURPOSE: Phase II trial to study the effectiveness of goserelin plus bicalutamide in treating patients who have refractory or recurrent cancer of the ovary, fallopian tube, or peritoneum.


Study summary:

OBJECTIVES: I. Determine the time-to-treatment failure in patients with ovarian epithelial, fallopian tube, or peritoneal carcinoma, in second or greater remission, treated with bicalutamide and goserelin. II. Assess luteinizing hormone and follicle-stimulating hormone suppression in correlation with serum vascular endothelial growth factor levels, and determine if these levels are related to time to treatment failure in these patients. III. Correlate the presence or absence of androgen receptor tissue expression by immunohistochemistry and androgen receptor gene trinucleotide repeat length to time to treatment failure in these patients. OUTLINE: Patients receive oral bicalutamide once daily and goserelin subcutaneously once every 4 weeks. Treatment continues in the absence of unacceptable toxicity until disease recurrence. PROJECTED ACCRUAL: A total of 35 patients will be accrued for this study.


Criteria:

DISEASE CHARACTERISTICS: Histologically confirmed epithelial carcinoma arising in the ovary, fallopian tube, or peritoneum, in second or greater remission Failed initial therapy with persistent or recurrent disease Cytoreductive surgery AND At least 1 platinum-based chemotherapy regimen No evidence of disease within 4 months of salvage chemotherapy CA-125 less than 35 U Negative physical exam No abdominal or pelvic disease by CT PATIENT CHARACTERISTICS: Age: Adult Performance status: Karnofsky 60-100% Life expectancy: Not specified Hematopoietic: Absolute neutrophil count at least 1,000/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin less than 2 times upper limit of normal (ULN) SGOT less than 2 times ULN Alkaline phosphatase less than 2 times ULN Renal: Not specified Other: No other active invasive malignancy No inability to receive subcutaneous injection No inability to tolerate oral medication PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: See Disease Characteristics Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: See Disease Characteristics Other: No concurrent oral anticoagulants


Study is Available At:


Original ID:

00-054


NCT ID:

NCT00012090


Secondary ID:

CDR0000068483


Study Acronym:


Brief Title:

Bicalutamide and Goserelin in Treating Patients With Cancer of the Ovary, Fallopian Tube, or Peritoneum


Official Title:

A Phase II Trial Of Oral Bicalutamide With Subcutaneous Goserelin In Patients With Epithelial Ovarian, Fallopian Tube, Or Peritoneal Carcinoma In Second Or Greater Remission


Overall Status:

Completed


Study Phase:

Phase 2


Genders:

Female


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Memorial Sloan-Kettering Cancer Center


Oversight Authority:

United States: Federal Government


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Primary Purpose: Treatment


Number of Arms:

0


Number of Groups:

0


Total Enrollment:

0


Enrollment Type:


Overall Contact Information

Official Name:Paul Sabbatini, MD
Study Chair
Memorial Sloan-Kettering Cancer Center

Study Dates

Start Date:September 2000
Completion Date:April 2004
Completion Type:Actual
Primary Completion Date:April 2004
Primary Completion Type:Actual
Verification Date:June 2013
Last Changed Date:June 17, 2013
First Received Date:March 3, 2001

Study Outcomes

There are no available Study Outcomes

Study Interventions

Intervention Type:Drug
Name:bicalutamide
Intervention Type:Drug
Name:goserelin acetate

Study Arms

There are no available Study Arms

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Memorial Sloan-Kettering Cancer Center
Agency Class:NIH
Agency Type:Collaborator
Agency Name:National Cancer Institute (NCI)

Sample and Retention Information

There are no available Sample and Retention Information

Study References

Reference Type:Results Reference
Citation:Levine D, Park K, Juretzka M, Esch J, Hensley M, Aghajanian C, Lewin S, Konner J, Derosa F, Spriggs D, Iasonos A, Sabbatini P. A phase II evaluation of goserelin and bicalutamide in patients with ovarian cancer in second or higher complete clinical disease remission. Cancer. 2007 Dec 1;110(11):2458-66.
PMID:17918264

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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