Fulvestrant in Treating Patients With Recurrent, Persistent, or Metastatic Endometrial Cancer

NCT00006903 | Unknown Phase 2 Results

• 5 other identifiers: GOG-0188NCI-2009-00581CDR0000068339U10CA180868U10CA027469
• Study Type: interventional
• Target: 67
• Locations: 0 countries
• Sites: N/A

Brief Summary

This phase II trial is studying fulvestrant to see how well it works in treating patients with recurrent, persistent, or metastatic endometrial cancer. Estrogen can stimulate the growth of cancer cells. Hormone therapy using fulvestrant may fight cancer by blocking the uptake of estrogen by the tumor cells.

Conditions

Recurrent Uterine Corpus Carcinoma; Stage III Uterine Corpus Cancer AJCC v7; Stage IV Uterine Corpus Cancer AJCC v7

Outcome Measures

Primary Outcomes (2)

• Clinical Response by Response Evaluation Criteria in Solid Tumors (RECIST) Criteria Evaluated Every 8 Weeks

  Primary outcome measured according to RECIST v1.0 Best Response: Complete Response (CR) is disappearance of all target and non-target lesions and no evidence of new lesions documented by two disease assessments at least 4 weeks apart Disease Progression is at least a 20% increase in the sum of LD of target lesions taking as references the smallest sum LD or the appearance of new lesions within 8 weeks of study entry. Partial Response (PR) is at least a 30% decrease in the sum of longest dimensions (LD) of all target measurable lesions taking as reference the baseline sum of LD. There can be no unequivocal progression of nontarget lesions and no new lesions. Documentation by two disease assessments at least 4 weeks apart is required Stable Disease is any condition not meeting the above criteria. Indeterminate is defined as having no repeat tumor assessments following initiation of study therapy for reasons unrelated to symptoms or signs of disease.

  Response was measured every other cycle (every 8 weeks) until disease progression is documented or adverse events preclude further treatment.

• Clinical Response by RECIST Criteria of Estrogen Receptor Expression

  Per response evaluation criteria in Solid Tumors Criteria (RECIST 1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR) \>=30% decrease in the sum of the longest diameter of target lesions. Overall Response = CR+PR

  Every other cycle (every 8 weeks) until disease progression is documented or adverse events preclude further treatment, assessed up to 100 months.

Secondary Outcomes (1)

• Number of Participants With Grade 3 or Greater Toxicity by Common Toxicity Criteria Version 3.0 That Were at Least Possibly Related to Study Drug.

  During study treatment and up to 30 days after stopping study

Study Arms (1)

Treatment (fulvestrant)

EXPERIMENTAL

Patients receive fulvestrant intramuscularly on day 1. Treatment repeats every 28 days for at least 2 courses in the absence of disease progression or unacceptable toxicity.

Drug: Fulvestrant

Interventions

Fulvestrant DRUG

Given intramuscularly

Also known as: Faslodex, Faslodex(ICI 182,780), ICI 182,780, ICI 182780, ZD9238

Treatment (fulvestrant)

Eligibility Criteria

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

Criteria: * Histologically confirmed recurrent, persistent, or metastatic endometrial cancer that is not curable with surgery or radiotherapy * Estrogen receptor (ER) and progesterone receptor status known by immunohistochemistry * ER positive or negative allowed * Measurable disease: * At least 1 target lesion not within a previously irradiated field OR irradiated target lesion with clear disease progression * At least 20 mm by conventional techniques, including palpation, x-ray, CT scan, MRI, OR at least 10 mm by spiral CT scan * Performance status: * GOG 0-1 * Hematopoietic: * Absolute neutrophil count \>= 1,500/mm\^3 * Platelet count \>= 100,000/mm\^3 * No prior bleeding diathesis (disseminated intravascular coagulation, clotting factor deficiency, or requirement for anticoagulants) * Hepatic: * Bilirubin =\< 1.5 times upper limit of normal (ULN) * SGOT =\< 3 times ULN * Alkaline phosphatase =\< 3 times ULN * Renal: * Creatinine =\< 2 mg/dL * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No hypersensitivity to castor oil * No other concurrent malignancy except nonmelanoma skin cancer * No other prior malignancy within past 5 years * No prior chemotherapy for persistent, recurrent, or metastatic endometrial cancer * No more than 1 prior chemotherapy regimen for newly diagnosed endometrial cancer that has subsequently recurred * At least 3 weeks since prior hormonal therapy and recovered * At least 3 weeks since prior radiotherapy and recovered * At least 3 weeks since prior surgery and recovered

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Gynecologic Oncology Group: lead
• National Cancer Institute (NCI): collaborator

MeSH Terms

Interventions

Fulvestrant

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

Limitations and Caveats

Accrual was discontinued after completion of the first stage of accrual due to lack of study drug activity.

Results Point of Contact

• Title: Melissa Leventhal
• Organization: NRG Oncology, Statistics and Data Management Center, Buffalo Office

mleventhal@gogstats.org

716-845-4030

Study Officials

• Allan L Covens

  NRG Oncology

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

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

Study Record Dates

• First Submitted: December 6, 2000
• First Posted: January 27, 2003
• Study Start: August 30, 2004
• Primary Completion: March 17, 2008
• Last Updated: March 20, 2019
• Results First Posted: June 24, 2014

Record last verified: 2019-03