- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00617188
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.
Study Overview
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.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
Minnesota
-
Minneapolis, Minnesota, United States, 55455
- Masonic Cancer Center at University of Minnesota
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Fulvestrant
Fulvestrant 500 milligrams (mg) Day 1; 250 mg Day 1, 29 and every 28 days thereafter.
|
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 Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Day 90
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Day 90
|
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.
|
Up to 373 Days
|
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.
|
Baseline, 3 Months Post Treatment, 6 Months Post Treatment
|
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.
|
Baseline, 1 Month, 3 Months, 6 Months
|
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.
|
Baseline, 1 Month, 3 Months, 6 Months
|
Collaborators and Investigators
Investigators
- Principal Investigator: Peter A. Argenta, MD, Masonic Cancer Center, University of Minnesota
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 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)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Ovarian Cancer
-
Roswell Park Cancer InstituteCompletedFallopian Tube Carcinoma | Primary Peritoneal Carcinoma | Stage IIA Ovarian Cancer | Stage IIB Ovarian Cancer | Stage IIC Ovarian Cancer | Stage IIIA Ovarian Cancer | Stage IIIB Ovarian Cancer | Stage IIIC Ovarian Cancer | Stage IV Ovarian Cancer | Stage IA Ovarian Cancer | Stage IB Ovarian Cancer | Stage IC... and other conditionsUnited States
-
City of Hope Medical CenterNational Cancer Institute (NCI)CompletedCancer Survivor | Stage IIIA Ovarian Epithelial Cancer | Stage IIIB Ovarian Epithelial Cancer | Stage IIIC Ovarian Epithelial Cancer | Stage IIA Ovarian Epithelial Cancer | Stage IIB Ovarian Epithelial Cancer | Stage IIC Ovarian Epithelial Cancer | Stage IA Ovarian Epithelial Cancer | Stage IB Ovarian... and other conditionsUnited States
-
Massachusetts General HospitalJohns Hopkins University; M.D. Anderson Cancer Center; National Cancer Institute... and other collaboratorsRecruitingOvarian Neoplasms | Fallopian Tube Neoplasms | Stage III Ovarian Cancer AJCC v8 | Stage IIIA Ovarian Cancer AJCC v8 | Stage IIIA1 Ovarian Cancer AJCC v8 | Stage IIIA2 Ovarian Cancer AJCC v8 | Stage IIIB Ovarian Cancer AJCC v8 | Stage IIIC Ovarian Cancer AJCC v8 | Stage IV Ovarian Cancer AJCC v8 | Stage... and other conditionsUnited States
-
Gynecologic Oncology GroupNational Cancer Institute (NCI)CompletedOvarian Clear Cell Cystadenocarcinoma | Ovarian Endometrioid Adenocarcinoma | Ovarian Seromucinous Carcinoma | Ovarian Serous Cystadenocarcinoma | Stage IV Ovarian Germ Cell Tumor | Ovarian Sarcoma | Malignant Ovarian Epithelial Tumor | Ovarian Carcinosarcoma | Ovarian Brenner Tumor | Ovarian Mucinous... and other conditionsUnited States
-
Gynecologic Oncology GroupNational Cancer Institute (NCI)CompletedStage IIA Fallopian Tube Cancer | Stage IIA Ovarian Cancer | Stage IIB Fallopian Tube Cancer | Stage IIB Ovarian Cancer | Stage IIC Fallopian Tube Cancer | Stage IIC Ovarian Cancer | Stage IIIA Fallopian Tube Cancer | Stage IIIA Ovarian Cancer | Stage IIIA Primary Peritoneal Cancer | Stage IIIB Fallopian... and other conditionsUnited States
-
University of WashingtonNational Cancer Institute (NCI)CompletedCaregiver | Stage IIIA Ovarian Cancer | Stage IIIB Ovarian Cancer | Stage IIIC Ovarian Cancer | Stage IV Ovarian CancerUnited States
-
Sidney Kimmel Cancer Center at Thomas Jefferson...CompletedStage I Breast Cancer | Stage I Uterine Corpus Cancer | Stage II Uterine Corpus Cancer | Stage III Uterine Corpus Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Stage IA Breast Cancer | Stage IB Breast Cancer | Stage IIA Breast Cancer | Stage IIB Breast Cancer | Stage... and other conditionsUnited States
-
Eve RodlerNot yet recruitingBreast Cancer | Ovarian Cancer | Breast Neoplasm | Breast Carcinoma | Breast Cancer Stage IV | Breast Cancer Stage I | Breast Cancer Stage II | Invasive Breast Cancer | Cancer, Breast | Breast Cancer Stage III | Ovary Cancer | Malignant Tumor of Breast | Ovarian Cancer Stage IIIC | Ovarian Cancer Stage IV | Ovarian Cancer... and other conditionsUnited States
-
Gynecologic Oncology GroupNational Cancer Institute (NCI)RecruitingStage IIIA Ovarian Cancer | Stage IIIB Ovarian Cancer | Stage IIIC Ovarian Cancer | Stage IV Ovarian CancerUnited States
-
Centre Leon BerardCancer Côte d'or registry; Cancer Calvados registryUnknownOvarian Epithelial CancerFrance
Clinical Trials on Fulvestrant
-
Genor Biopharma Co., Ltd.RecruitingLocally Advanced or Metastatic Breast CancerChina
-
Ontario Clinical Oncology Group (OCOG)AstraZenecaCompleted
-
Xuanzhu Biopharmaceutical Co., Ltd.RecruitingAdvanced Breast CancerChina
-
Ahon Pharmaceutical Co., Ltd.RecruitingAdvanced Breast Cancer | Female Breast CancerChina
-
Jiangsu Hansoh Pharmaceutical Co., Ltd.Recruiting
-
Roswell Park Cancer InstituteCompleted
-
Fudan UniversityActive, not recruiting
-
Alliance for Clinical Trials in OncologyNational Cancer Institute (NCI)Completed
-
Sun Yat-sen UniversityAstraZenecaUnknown
-
Zhejiang Cancer HospitalRecruitingBreast Neoplasm FemaleChina