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Fulvestrant in Treating Patients With Recurrent Ovarian Epithelial Cancer

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ClinicalTrials.gov Identifier: NCT00617188
Recruitment Status : Completed
First Posted : February 15, 2008
Results First Posted : March 17, 2010
Last Update Posted : November 12, 2012
Sponsor:
Information provided by (Responsible Party):

February 14, 2008
February 15, 2008
June 12, 2009
March 17, 2010
November 12, 2012
June 2007
April 2008   (Final data collection date for primary outcome measure)
Patients' Overall 90-Day Clinical Response as Measured by Response Evaluation Criteria in Solid Tumors (RECIST) [ Time Frame: Day 90 ]
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.
90-day clinical benefit (sum of the complete responses, partial responses, and stable disease) as assessed by RECIST
Complete list of historical versions of study NCT00617188 on ClinicalTrials.gov Archive Site
  • Patients' Overall 90-Day Clinical Response as Measured by Modified Response Evaluation Criteria in Solid Tumors (Rustin) [ Time Frame: Day 90 ]
    Defined by the sum of Complete Responses (CR), Partial Responses (PR) and Stable Disease (SD) in patients treated with fulvestrant. CR=normalization of serum CA-125 level from 2 initially elevated samples, PR=>or=50% decrease in serum CA-125 level from 2 initially elevated samples, Progressive Disease (PD)=CA-125 two times the upper limit of normal on 2 occasions (if previously normalized) OR CA-125 two times nadir (lowest value) on 2 occasions if elevated at initiation of treatment, SD=not CR, PR or PD.
  • Median Number of Days to Treatment Termination [ Time Frame: Up to 373 Days ]
    Time is determined from first dose to termination due to all causes.
  • Mean Scores - Quality of Life Assessment [ Time Frame: Baseline, 3 Months Post Treatment, 6 Months Post Treatment ]
    Functional Assessment of Cancer Therapy-Ovarian Cancer (FACT-O)Version 1/23/07 - This is a relative quality of life assessment; 100 = Best, 0 = Worst. It was developed and validated with cancer patients and includes physical well being, social well being, emotional well being and relationship with doctor subscales and can be summed into one total quality of life score. It is a standardized scale which collects data (scores 1-4) from 47 questions. Answers are transformed into a number between 0-100. Mean was calculated by adding up the values of the scores and dividing by the number of scores.
  • Serum Skeletal-Specific Alkaline Phosphatase Concentration [ Time Frame: Baseline, 1 Month, 3 Months, 6 Months ]
    Median Bone mineral results - assessed by serum skeletal-specific alkaline phosphatase laboratory results collected from patients in study.
  • Urine N-telopeptide Concentration [ Time Frame: Baseline, 1 Month, 3 Months, 6 Months ]
    Median bone mineral results - assessed by serial urine N-telopeptide laboratory results collected from patients.
  • Time to treatment termination due to all causes
  • Toxicity and adverse events as assessed by NCI CTCAE V3.0
  • Quality of life as assessed by FACT-O at baseline, every 3 months during treatment, at time of early termination (if applicable), and at the final treatment visit
  • Changes in bone mineral turnover rates as assessed by serial urine N-telopeptide and serum skeletal-specific alkaline phosphatase
Not Provided
Not Provided
 
Fulvestrant in Treating Patients With Recurrent Ovarian Epithelial Cancer
Phase II Trial of Fulvestrant in Treatment of Recurrent Ovarian Carcinoma

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.

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.

Interventional
Phase 2
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Ovarian Cancer
Drug: 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.
Other Name: Faslodex
Experimental: Fulvestrant
Fulvestrant 500 milligrams (mg) Day 1; 250 mg Day 1, 29 and every 28 days thereafter.
Intervention: Drug: Fulvestrant
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
26
July 2008
April 2008   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: Female
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00617188
CDR0000582821
UMN-2007LS003 ( Other Identifier: Clinical Trials Office, University of Minnesota )
UMN-WCC-49 ( Other Identifier: Women's Cancer Center, University of Minnesota )
UMN-0612M97626 ( Other Identifier: IRB, University of Minnesota )
IRUSFULV0062 ( Other Identifier: AstraZeneca )
Yes
Not Provided
Not Provided
Masonic Cancer Center, University of Minnesota
Masonic Cancer Center, University of Minnesota
Not Provided
Principal Investigator: Peter A. Argenta, MD Masonic Cancer Center, University of Minnesota
Masonic Cancer Center, University of Minnesota
November 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP