NCT00551070 · REGISTRY CONDITION SEARCH

Selumetinib Sulfate in Treating Woman With Recurrent Low-Grade Ovarian Cancer or Peritoneum Cancer

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase: PHASE2
Status at capture: COMPLETED
Registry last update: 2020-12-03

This phase II trial studies the side effects and how well selumetinib sulfate works in treating patients with low-grade ovarian cancer that has come back (recurrent). Selumetinib sulfate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Tumor Response

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outcome · POSTED

Progression-free Survival

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outcome · POSTED

Number of Courses Received

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outcome · POSTED

Adverse Events (Grade 3 or Higher) During First Cycle of Treatment

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outcome · POSTED

Area Under the Curve (AUC) for AZD6244, 100 mg Administered Orally Twice Daily.

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outcome · POSTED

Maximum Concentration (Cmax) for AZD6244, 100 mg Administered Orally Twice Daily.

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outcome · POSTED

Overall Survival

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part

eligibility Criteria: Inclusion Criteria: * Patients age greater than 18 with the following tumors are included in the study: * Patients initially diagnosed with low-grade serous ovarian or peritoneal carcinoma that recur as low grade serous carcinoma (invasive micropapillary serous carcinoma or invasive grade I serous carcinomas as defined by Gynecologic Oncology Group \[GOG\], International Federation of Gynecology and Obstetrics \[FIGO\] World Health Organization \[WHO\] or Silverberg) * Patients initially diagnosed with serous borderline ovarian or peritoneal carcinoma that recur as low grade serous carcinoma (invasive micropapillary serous carcinoma or invasive grade I serous carcinomas as defined by GOG, FIGO WHO or Silverberg) * Patients must have measurable disease: * Measurable disease is defined as at least one lesion that can be accurately measured in at least one dimension (longest dimension to be recorded); each "target" lesion must be \>= 20 mm when measured by conventional techniques, including palpation, plain x-ray, computed tomography (CT), and magnetic resonance imaging (MRI), or \>= 10 mm when measured by spiral CT * Patient must have documented low grade serous carcinoma (invasive micropapillary serous); confirmation must occur before patient is considered eligible for the trial * Patients whose primary tumor was low-grade serous ovarian or peritoneal carcinoma must have a pretreatment sample of their tumor from their primary or recurrent tumor that documents low grade serous carcinoma (invasive micropapillary serous) * Patients whose primary tumor was serous borderline ovarian or peritoneal carcinoma must have a pretreatment sample of their tumor from their recurrent tumor that documents low grade serous carcinoma (invasive micropapillary serous) * Creatinine CTCAE grade 0-1 (\< 1.5 x upper limit of normal \[ULN\]) * Bilirubin CTCAE grade 0-1 (\< 1.5 x ULN) * Transaminases CTCAE grade 0-1 (\< 2.5 x ULN) * Neutrophil CTCAE grade 0-1 (\>= 1500/mcl) * Platelets CTCAE grade 0-1 (\>= 100,000/mcl) * Neuropathy =\< CTCAE grade 1 * No restrictions on prior therapy; patients cannot have previously received AZD6244 * Patients of childbearing potential must have a negative pregnancy test and must agree to practice an effective means of birth control prior to study entry, for the duration of study participation, and for four weeks after dosing with AZD6244 ceases * Patients who have met the pre-entry requirements * Patients must have signed an approved informed consent and authorization permitting release of personal health information * Patients must have a GOG performance status of 0 or 1 Exclusion Criteria: * Patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier * Patients may not be receiving any other investigational agents * Patients with known brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events * History of allergic reactions attributed to compounds of similar chemical or biologic composition to AZD6244 or its excipient Captisol * Previous mitogen-activated protein kinase (MEK) inhibitor use * Patients with corrected QT (QTc) interval \> 450 msecs or other factors that increase the risk of QT prolongation or arrhythmic events (e.g., heart failure, hypokalemia, family history of long QT interval syndrome) including heart failure that meets New York Heart Association (NYHA) class III and IV definitions are excluded * Required use of a concomitant medication that can prolong the QT interval * Patients should not receive any drugs known to affect or with the potential to affect selected CYP450 isoenzymes * Refractory nausea and vomiting, chronic gastrointestinal diseases (e.g. inflammatory bowel disease), or significant bowel resection that would preclude adequate absorption * Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection or psychiatric illness/social situations that would limit compliance with study requirements * Pregnant women are excluded from this study because the effects of AZD6244 on the developing human fetus at the recommended therapeutic dose are unknown; because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother, breastfeeding should be discontinued if the mother is treated with AZD6244 * Human immunodeficiency virus (HIV)-positive patients on combination antiretroviral therapy are ineligible because of the potential for pharmacokinetic interactions with AZD6244; appropriate studies will be undertaken in patients receiving combination antiretroviral therapy when indicated
healthy Volunteers: false
minimum Age: 19 Years
sex: FEMALE
std Ages: ADULT
OLDER_ADULT

Treatment arms and interventions

arm Groups

description
Patients receive selumetinib sulfate PO BID on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
intervention Names
Other: Laboratory Biomarker Analysis
Other: Pharmacological Study
Drug: Selumetinib
Drug: Selumetinib Sulfate
label
Treatment (selumetinib sulfate)
type
EXPERIMENTAL

interventions

arm Group Labels
Treatment (selumetinib sulfate)
description
Correlative studies
name
Laboratory Biomarker Analysis
type
OTHER
arm Group Labels
Treatment (selumetinib sulfate)
description
Correlative studies
name
Pharmacological Study
type
OTHER
arm Group Labels
Treatment (selumetinib sulfate)
description
Given PO
name
Selumetinib
other Names
ARRY-142886
AZD6244
MEK Inhibitor AZD6244
type
DRUG
arm Group Labels
Treatment (selumetinib sulfate)
description
Given PO
name
Selumetinib Sulfate
other Names
AZD-6244 Hydrogen Sulfate
AZD6244 Hydrogen Sulfate
AZD6244 Hydrogen Sulphate
Koselugo
Selumetinib Sulphate
type
DRUG

Study design

allocation

intervention Model

SINGLE_GROUP

masking Info

masking: NONE

primary Purpose

TREATMENT

Enrollment

count: 52
type: ACTUAL

Registered outcome plans (not posted results)

primary Outcomes

description
Complete and Partial Tumor Response by (Response Evaluation Criteria in Solid Tumors) RECIST 1.0
measure
Tumor Response
time Frame
Every other cycle
measure
Adverse Events (Grade 3 or Higher) During First Cycle of Treatment
time Frame
Cycle 1
measure
Area Under the Curve (AUC) for AZD6244, 100 mg Administered Orally Twice Daily.
time Frame
Pre-dose, and 1, 3, and 6 hours after administration of drug on Day 7 after the start of AZD6244 treatment
measure
Maximum Concentration (Cmax) for AZD6244, 100 mg Administered Orally Twice Daily.
time Frame
Pre-dose, and 1, 3, and 6 hours after administration of drug on Day 7 after the start of AZD6244 treatment

secondary Outcomes

measure
Progression-free Survival
time Frame
Every other cycle
measure
Number of Courses Received
time Frame
Every cycle
measure
Overall Survival
time Frame
Every cycle during treatment, then every 3 months for the first 2 years, then every six months for the next three years and then annually for the next 5 years

Full study description

brief Summary: This phase II trial studies the side effects and how well selumetinib sulfate works in treating patients with low-grade ovarian cancer that has come back (recurrent). Selumetinib sulfate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
detailed Description: PRIMARY OBJECTIVES: I. To examine the tumor response rate of patients on AZD6244 (selumetinib sulfate) (NSC #748727). II. To examine the acute toxicity of AZD6244 (NSC #748727) during the first course of treatment using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. III. To define the pharmacokinetic profile for AZD6244, 100 mg administered orally twice daily. SECONDARY OBJECTIVES: I. To examine the toxicity of AZD6244 (NSC #748727) using the 21 major categories of the CTCAE version 3.0. II. To examine the dose and number of courses of AZD6244 (NSC #748727) given. III. To estimate the progression free survival, and overall survival of women receiving AZD6244 (NSC #748727). TRANSLATIONAL RESEARCH OBJECTIVES: I. To examine deoxyribonucleic acid (DNA) isolation with sequencing of braf, and ras mutation analysis and to explore their relationship with tumor response with AZD6244 (NSC #748727). II. To examine protein levels of phosphorylated (p)-ERK/ERKERK) and explore their relationship with tumor response in patients treated with AZD6244 (NSC #748727). OUTLINE: Patients receive selumetinib sulfate orally (PO) twice a day (BID) on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo blood sample collection periodically for correlative and pharmacokinetic studies and to analyze selumetinib sulfate peak concentrations and the corresponding peak time values. Previously collected archived tumor tissue samples are obtained to determine protein levels of p-ERK/ERKERK, DNA isolation and sequencing of BRAF and ras mutation analysis by immunohistochemistry (IHC). After completion of study treatment, patients are followed every 3 months for 2 years, every 6 months for 3 years, and then once a year for 5 years.

Source references

references

citation
Farley J, Brady WE, Vathipadiekal V, Lankes HA, Coleman R, Morgan MA, Mannel R, Yamada SD, Mutch D, Rodgers WH, Birrer M, Gershenson DM. Selumetinib in women with recurrent low-grade serous carcinoma of the ovary or peritoneum: an open-label, single-arm, phase 2 study. Lancet Oncol. 2013 Feb;14(2):134-40. doi: 10.1016/S1470-2045(12)70572-7. Epub 2012 Dec 21.
pmid
23261356
type
DERIVED

Source notices and limitations

Discovery and provenance

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query disease state id
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source file
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source url
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Preserved source evidence · Not medical advice