Fulvestrant in Treating Patients With Recurrent Ovarian Epithelial Cancer

University of Minnesota (UMN)

Status and phase

Completed

Phase 2

Conditions

Ovarian Cancer

Treatments

Drug: Fulvestrant

Study type

Interventional

Funder types

Other

Identifiers

NCT00617188

CDR0000582821

UMN-WCC-49 (Other Identifier)

UMN-2007LS003 (Other Identifier)

UMN-0612M97626 (Other Identifier)

IRUSFULV0062 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment

26 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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