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Ovarian CancerPhase 2NCT00617188

Fulvestrant in Treating Patients With Recurrent Ovarian Epithelial Cancer

A Phase 2 study testing Fulvestrant in people with Ovarian Cancer, run by Masonic Cancer Center, University of Minnesota at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Ovarian Cancer
What is being tested?
Fulvestrant
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
26 participants
Where
1 siteUnited States
Study dates
Jun 2007to Jul 2008
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 27Show fewer
  • 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

Who cannot join

  • Concurrent hormone replacement therapy
  • Prior long-term anticoagulation therapy other than anti-platelet therapy

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Masonic Cancer Center at University of Minnesota

    Minneapolis, Minnesota, 55455

Other trials in United States

About this study

Official title: 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.

Read the 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.

Conditions
Ovarian Cancer
Being tested
Fulvestrant
Keywords
recurrent ovarian epithelial cancer
Medical subject headings
Ovarian Neoplasms, Carcinoma, Ovarian Epithelial

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • FulvestrantDrug

    Also called Faslodex

    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.

Study groups in NCT00617188
Study groupRoleWhat they receive
FulvestrantExperimentalFulvestrant 500 milligrams (mg) Day 1; 250 mg Day 1, 29 and every 28 days thereafter.
Receives: Drug: Fulvestrant

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    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.

    Measured: Day 90

Secondary outcomes (5)

  1. Patients' Overall 90-Day Clinical Response as Measured by Modified Response Evaluation Criteria in Solid Tumors (Rustin)

    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.

    Measured: Day 90

  2. Median Number of Days to Treatment Termination

    Time is determined from first dose to termination due to all causes.

    Measured: Up to 373 Days

  3. Mean Scores - Quality of Life Assessment

    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.

    Measured: Baseline, 3 Months Post Treatment, 6 Months Post Treatment

  4. Serum Skeletal-Specific Alkaline Phosphatase Concentration

    Median Bone mineral results - assessed by serum skeletal-specific alkaline phosphatase laboratory results collected from patients in study.

    Measured: Baseline, 1 Month, 3 Months, 6 Months

  5. Urine N-telopeptide Concentration

    Median bone mineral results - assessed by serial urine N-telopeptide laboratory results collected from patients.

    Measured: Baseline, 1 Month, 3 Months, 6 Months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Feb 2008 (estimated)
  2. Study startJun 2007
  3. Primary completionApr 2008
  4. Study completionJul 2008

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
26 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00617188
Sponsor's protocol ID
CDR0000582821
Other IDs
UMN-2007LS003, UMN-WCC-49, UMN-0612M97626, IRUSFULV0062
Status last verified
Dec 2017
First submitted
14 Feb 2008
Last updated
28 Dec 2017
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 19239974

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Fulvestrant in people with Ovarian Cancer, run by Masonic Cancer Center, University of Minnesota at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 27 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 17 Mar 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Patients' Overall 90-Day Clinical Response as Measured by Response Evaluation Criteria in Solid Tumors (RECIST) (time frame: Day 90). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00617188, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Dec 2017.

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