Clinical trial NCT00617188: Fulvestrant in Treating Patients With Recurrent Ovarian Epithelial Cancer
Official title: Phase II Trial of Fulvestrant in Treatment of Recurrent Ovarian Carcinoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Ovarian Cancer
Keywords: recurrent ovarian epithelial cancer
Lead sponsor: Masonic Cancer Center, University of Minnesota
Sponsor class: OTHER
First posted: 2008-02-15
Enrollment: 26
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Patients' Overall 90-Day Clinical Response as Measured by Response Evaluation Criteria in Solid Tumors (RECIST)
timeFrame: Day 90
Secondary outcomes:
measure: Patients' Overall 90-Day Clinical Response as Measured by Modified Response Evaluation Criteria in Solid Tumors (Rustin)
timeFrame: Day 90
measure: Median Number of Days to Treatment Termination
timeFrame: Up to 373 Days
measure: Mean Scores - Quality of Life Assessment
timeFrame: Baseline, 3 Months Post Treatment, 6 Months Post Treatment
measure: Serum Skeletal-Specific Alkaline Phosphatase Concentration
timeFrame: Baseline, 1 Month, 3 Months, 6 Months
measure: Urine N-telopeptide Concentration
timeFrame: Baseline, 1 Month, 3 Months, 6 Months
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: Masonic Cancer Center at University of Minnesota
state: Minnesota
Study officials:
affiliation: Masonic Cancer Center, University of Minnesota
name: Peter A. Argenta, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.