Fulvestrant in Treating Patients With Recurrent Ovarian Epithelial Cancer

NCT ID: NCT00617188

Last Updated: 2017-12-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 26 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-06-30
• Study Completion Date: 2008-07-31

Brief Summary

RATIONALE: Estrogen can cause the growth of ovarian epithelial cancer cells. Hormone therapy using fulvestrant may fight ovarian cancer by blocking the use of estrogen by the tumor cells.

PURPOSE: This phase II trial is studying how well fulvestrant works in treating patients with recurrent ovarian epithelial cancer.

Detailed Description

OBJECTIVES:

Primary

• To determine the 90-day clinical benefit (defined as the sum of complete responses, partial responses, and stable disease) in patients with recurrent ovarian epithelial cancer treated with single agent fulvestrant.

Secondary

• To establish the time to termination of treatment (due to all causes including progression and intolerance) for patients treated with this drug.
• To describe the toxicities observed in patients treated with this drug.
• To evaluate the quality of life of patients treated with this drug.
• To determine the effect that prolonged estrogen receptor antagonism has on markers of bone mineral turnover.

OUTLINE: Patients receive fulvestrant intramuscularly on days 1 and 15 of course 1 and then on day 1 of all subsequent courses. Treatment repeats every 28 days for up to 1 year in the absence of disease progression or unacceptable toxicity. Patients in continued response at the end of 1 year may continue treatment at the discretion of the treating physician.

Urinary N-telopeptide and serum skeletal-specific alkaline phosphatase are assessed at baseline and at 1, 3, and 6 months during study to determine the influence of estrogen blockade on bone mineral turnover.

Quality of life is assessed at baseline and every 3 months during treatment, and at the end of treatment using The Functional Assessment of Cancer Therapy - Ovarian (FACT-O) cancer questionnaire.

After completion of study treatment, patients are followed at approximately 30 days.

Conditions

Ovarian Cancer

Keywords

recurrent ovarian epithelial cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Fulvestrant

Fulvestrant 500 milligrams (mg) Day 1; 250 mg Day 1, 29 and every 28 days thereafter.

Group Type: EXPERIMENTAL

Fulvestrant

Intervention Type: DRUG

Fulvestrant, 500 milligrams (mg) intramuscularly (IM) on Day 1, 250 mg IM on Day 15, and 250 mg IM on Day 29 and every 28 days thereafter until either intolerance or disease progression.

Interventions

Fulvestrant

Fulvestrant, 500 milligrams (mg) intramuscularly (IM) on Day 1, 250 mg IM on Day 15, and 250 mg IM on Day 29 and every 28 days thereafter until either intolerance or disease progression.

Intervention Type: DRUG

Other Intervention Names

Faslodex

Eligibility Criteria

Inclusion Criteria

• Histologically confirmed ovarian epithelial carcinoma

• Recurrent or persistent disease

• Must have received greater than or equal to (≥) 2 prior cytotoxic chemotherapy regimens, including ≥ 1 platinum-containing regimen
• Disease not amenable to curative treatment with surgery and/or radiotherapy
• Must have measurable disease according to Response Evaluation Criteria In Solid Tumors (RECIST) and/or a serum cancer antigen 125 (CA-125) level that is rising and meets 1 of the following criteria:

• Serum CA-125 level greater than (>) upper limit of normal (typically 35 μ/mL) on two evaluations at least 2 weeks apart
• Serum CA-125 level less than (<) 35 μ/mL but has risen progressively > 200% over successive specimens ≥ 2 weeks apart
• Estrogen receptor-positive tumor
• Gynecologic Oncology Group (GOG) performance status 0-3
• Platelet count ≥ 50 x 10^9/Liter
• Serum creatinine less than or equal to (≤) 2.5 mg/deciliter
• Bilirubin ≤ 1.5 times upper limit of normal (ULN)
• Serum glutamic oxaloacetic transaminase (SGOT) ≤ 3 times upper limit of normal (ULN)
• alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≤ 2.5 times ULN (≤ 5 times ULN in the presence of liver metastases)
• Alkaline phosphatase ≤ 3 times ULN
• Prothrombin time-International Normalized Ratio (INR) ≤ 1.6
• Not pregnant or nursing
• Negative pregnancy test
• Must be sterile or fertile patients must use effective contraception (i.e., double method including ≥ 1 barrier, injectable, implantable, condoms plus spermicide)
• Prior malignancy allowed provided the patient has been disease-free for ≥ 5 years

• Patients with previously diagnosed basal cell skin cancer are eligible immediately after completing therapy
• No history of bleeding (i.e., disseminated intravascular coagulation or clotting factor deficiency)
• No documented sensitivity to active or inactive excipients of fulvestrant (i.e., castor oil or mannitol)
• Recovered from the effects of prior surgery, radiotherapy, and/or chemoradiotherapy
• At least 3 weeks since prior chemotherapy
• At least 3 weeks since prior complete radiotherapy regimen alone or chemoradiotherapy

• An incomplete radiotherapy regimen (< 500 Gray) is allowed within the 3-week time frame

Exclusion Criteria

• Concurrent hormone replacement therapy
• Prior long-term anticoagulation therapy other than anti-platelet therapy

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Masonic Cancer Center, University of Minnesota

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Peter A. Argenta, MD

Role: PRINCIPAL_INVESTIGATOR

Masonic Cancer Center, University of Minnesota

Locations

Masonic Cancer Center at University of Minnesota

Minneapolis, Minnesota, United States

Countries

United States

References

Argenta PA, Thomas SG, Judson PL, Downs LS Jr, Geller MA, Carson LF, Jonson AL, Ghebre R. A phase II study of fulvestrant in the treatment of multiply-recurrent epithelial ovarian cancer. Gynecol Oncol. 2009 May;113(2):205-9. doi: 10.1016/j.ygyno.2009.01.012. Epub 2009 Feb 23.

Reference Type: RESULT

PMID: 19239974 (View on PubMed)

Other Identifiers

UMN-2007LS003

Identifier Type: OTHER

Identifier Source: secondary_id

UMN-WCC-49

Identifier Type: OTHER

Identifier Source: secondary_id

UMN-0612M97626

Identifier Type: OTHER

Identifier Source: secondary_id

IRUSFULV0062

Identifier Type: OTHER

Identifier Source: secondary_id

CDR0000582821

Identifier Type: -

Identifier Source: org_study_id