Fulvestrant in Treating Patients With Recurrent Ovarian Epithelial Cancer

NCT00617188 | Completed Phase 2 Results DMC

• 5 other identifiers: CDR0000582821UMN-2007LS003UMN-WCC-49UMN-0612M97626IRUSFULV0062
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Ovarian Cancer

Keywords

recurrent ovarian epithelial cancer

Outcome Measures

Primary Outcomes (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.

  Day 90

Secondary Outcomes (5)

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

  Day 90

• Median Number of Days to Treatment Termination

  Up to 373 Days

• Mean Scores - Quality of Life Assessment

  Baseline, 3 Months Post Treatment, 6 Months Post Treatment

• Serum Skeletal-Specific Alkaline Phosphatase Concentration

  Baseline, 1 Month, 3 Months, 6 Months

• Urine N-telopeptide Concentration

  Baseline, 1 Month, 3 Months, 6 Months

Study Arms (1)

Fulvestrant

EXPERIMENTAL

Fulvestrant 500 milligrams (mg) Day 1; 250 mg Day 1, 29 and every 28 days thereafter.

Drug: Fulvestrant

Interventions

Fulvestrant DRUG

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.

Also known as: Faslodex

Fulvestrant

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Masonic Cancer Center, University of Minnesota: lead

Study Sites (1)

Masonic Cancer Center at University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

Related Publications (1)

• 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.

  PMID: 19239974 RESULT

MeSH Terms

Conditions

Ovarian Neoplasms; Carcinoma, Ovarian Epithelial

Interventions

Fulvestrant

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Estradiol; Estrenes; Estranes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Estradiol Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Results Point of Contact

• Title: Peter Argenta, M.D.
• Organization: Masonic Cancer Center, University of Minnesota

argenta@umn.edu

612-626-6037

Study Officials

• Peter A. Argenta, MD

  Masonic Cancer Center, University of Minnesota

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 14, 2008
• First Posted: February 15, 2008
• Study Start: June 1, 2007
• Primary Completion: April 1, 2008
• Study Completion: July 1, 2008
• Last Updated: December 28, 2017
• Results First Posted: March 17, 2010

Record last verified: 2017-12

Locations

US (1)