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Phase II Trial of Fulvestrant in Treatment of Recurrent Ovarian Carcinoma

Phase 2
18 Years
Not Enrolling
Ovarian Cancer

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Trial Information

Phase II Trial of Fulvestrant in Treatment of Recurrent Ovarian Carcinoma



- 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.


- 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

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

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

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Patients' Overall 90-Day Clinical Response as Measured by Response Evaluation Criteria in Solid Tumors (RECIST)

Outcome Description:

Best response recorded from the start of treatment until Day 90. Defined by the sum of the Complete Responses (CR), Partial Responses (PR) and Stable Disease (SD) in patients treated with fulvestrant. CR=disappearance of all lesions, PR=>or =30% decrease in sum of all target lesions, Progressive Disease (PD) =>or=20% increase in sum of all target or any new lesions, SD=not CR, PR or PD.

Outcome Time Frame:

Day 90

Safety Issue:


Principal Investigator

Peter A. Argenta, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Masonic Cancer Center, University of Minnesota


United States: Food and Drug Administration

Study ID:




Start Date:

June 2007

Completion Date:

July 2008

Related Keywords:

  • Ovarian Cancer
  • recurrent ovarian epithelial cancer
  • Ovarian Neoplasms
  • Neoplasms, Glandular and Epithelial



Masonic Cancer Center at University of Minnesota Minneapolis, Minnesota  55455