Fulvestrant in Treating Patients With Recurrent Ovarian Epithelial Cancer - Full Text View

Sponsors and Collaborators:	Masonic Cancer Center, University of Minnesota National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00617188

Purpose

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.

Condition	Intervention	Phase
Ovarian Cancer	Drug: fulvestrant Other: laboratory biomarker analysis Procedure: quality-of-life assessment	Phase II

MedlinePlus related topics: Cancer Ovarian Cancer

Drug Information available for: Ici 182780

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized
Official Title:	Phase II Trial of Fulvestrant in Treatment of Recurrent Ovarian Carcinoma

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

90-day clinical benefit (sum of the complete responses, partial responses, and stable disease) as assessed by RECIST [ Designated as safety issue: No ]

Secondary Outcome Measures:

Time to treatment termination due to all causes [ Designated as safety issue: No ]
Toxicity and adverse events as assessed by NCI CTCAE V3.0 [ Designated as safety issue: Yes ]
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 [ Designated as safety issue: No ]
Changes in bone mineral turnover rates as assessed by serial urine N-telopeptide and serum skeletal-specific alkaline phosphatase [ Designated as safety issue: No ]

Estimated Enrollment:	27
Study Start Date:	June 2007
Estimated Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

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.

Tertiary

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 cancer questionnaire.

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

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

DISEASE CHARACTERISTICS:

Histologically confirmed ovarian epithelial carcinoma
- Recurrent or persistent disease
  - Must have received ≥ 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 RECIST and/or a serum CA-125 level that is rising and meets 1 of the following criteria:
- Serum CA-125 level > upper limit of normal (typically 35 μ/mL) on two evaluations at least 2 weeks apart
- Serum CA-125 level < 35 μ/mL but has risen progressively > 200% over successive specimens ≥ 2 weeks apart
Estrogen receptor-positive tumor

PATIENT CHARACTERISTICS:

GOG performance status 0-3
Platelet count ≥ 50 x 10^9/L
Serum creatinine ≤ 2.5 mg/dL
Bilirubin ≤ 1.5 times upper limit of normal (ULN)
SGOT ≤ 3 times ULN
ALT or AST ≤ 2.5 times ULN (≤ 5 times ULN in the presence of liver metastases)
Alkaline phosphatase ≤ 3 times ULN
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)

PRIOR CONCURRENT THERAPY:

See Disease Characteristics
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 Gy) is allowed within the 3-week time frame
No concurrent hormone replacement therapy
No prior long-term anticoagulation therapy other than anti-platelet therapy

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00617188

Locations

United States, Minnesota
Masonic Cancer Center at University of Minnesota
Minneapolis, Minnesota, United States, 55455

Sponsors and Collaborators

Masonic Cancer Center, University of Minnesota

National Cancer Institute (NCI)

Investigators

Principal Investigator:

Peter A. Argenta, MD

Masonic Cancer Center, University of Minnesota

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Masonic Cancer Center at University of Minnesota ( Peter A. Argenta )
Study ID Numbers:	CDR0000582821, UMN-2007LS003, UMN-WCC-49, UMN-0612M97626, UMN-2007UC003, ZENECA-UMN-2007LS003
Study First Received:	February 14, 2008
Last Updated:	February 6, 2009
ClinicalTrials.gov Identifier:	NCT00617188 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

recurrent ovarian epithelial cancer

Study placed in the following topic categories:

Estrogen Antagonists
Estrogens
Ovarian Neoplasms
Antineoplastic Agents, Hormonal
Gonadal Disorders
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Fulvestrant
Genital Neoplasms, Female
Endocrine System Diseases
Urogenital Neoplasms

Ovarian Diseases
Ovarian Epithelial Cancer
Hormones
Recurrence
Carcinoma
Genital Diseases, Female
Estrogen Receptor Modulators
Ovarian Cancer
Endocrinopathy
Endocrine Gland Neoplasms

Additional relevant MeSH terms:

Estrogen Antagonists
Ovarian Neoplasms
Antineoplastic Agents, Hormonal
Gonadal Disorders
Antineoplastic Agents
Hormone Antagonists
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Genital Neoplasms, Female
Fulvestrant
Endocrine System Diseases

Urogenital Neoplasms
Ovarian Diseases
Pharmacologic Actions
Adnexal Diseases
Genital Diseases, Female
Estrogen Receptor Modulators
Neoplasms
Neoplasms by Site
Therapeutic Uses
Endocrine Gland Neoplasms

ClinicalTrials.gov processed this record on May 07, 2009