Jonathan S. Berek
AZD6244 in Treating Woman With Recurrent Low-Grade Ovarian Cancer
Contact Information
Stanford University School of Medicine 300 Pasteur Drive Stanford, CA 94305Brief
RATIONALE: AZD6244 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. PURPOSE: This phase II trial is studying the side effects and how well AZD6244 works in treating patients with recurrent low-grade ovarian cancer.
Recruiting Status:
RecruitingStanford Recruiting Status:
RecruitingCondition(s):
Intervention(s):
- Drug: MEK inhibitor AZD6244
- Procedure: diagnostic procedure
- Procedure: immunohistochemistry staining method
- Procedure: mutation analysis
- Procedure: pharmacological study
- Procedure: protein expression analysis
- Procedure: protein tyrosine kinase inhibitor therapy
Phase:
Phase 2Eligibility
Ages Eligible for Study:
19 years to Any AgeGenders Eligible for Study:
FemaleHealth of Volunteers:
People with the conditions listed in this trial can participate as controls.Key Inclusion Criteria:
DISEASE CHARACTERISTICS:
- Meeting 1 of the following diagnosis:
o Low-grade ovarian carcinoma that recurred as low-grade serous carcinoma (invasive micropapillary serous carcinoma or invasive grade I serous carcinomas as defined by GOG, FIGO WHO, or S. G. Silverberg)
o Serous borderline ovarian carcinoma that recurred as low-grade serous carcinoma (invasive micropapillary serous carcinoma or invasive grade I serous carcinomas as defined by GOG, FIGO WHO, or S. G. Silverberg)
- Measurable disease, defined as >= 1 unidimensionally measurable lesion >= 20 mm by conventional techniques including palpation, plain x-ray, CT scan, or MRI scan, OR >= 10 mm by spiral CT scan
- Must have a pretreatment tumor tissue sample available from previous surgery or biopsy documenting low-grade serous carcinoma (invasive micropapillary serous)
- No known brain metastases
PATIENT CHARACTERISTICS:
- GOG performance status 0-1
- Platelet count >= 100,000/mm^3
- ANC count >= 1,500/mm^3
- Bilirubin < 1.5 times upper limit of normal (ULN)
- Creatinine < 1.5 times ULN
- Transaminases < 2.5 times ULN
- Neuropathy <= grade 1
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception prior to, during, and for 4 weeks after completion of study therapy
- QTc interval <= 450 msec and no factors that increase the risk of QT prolongation or arrhythmic events including, but not limited to, any of the following:
o Heart failure
o Hypokalemia
o Family history of long QT interval syndrome
o NYHA class III-IV heart failure
- No history of allergic reactions attributed to compounds of similar chemical or biological composition to AZD6244 or its excipient Captisol?
- No refractory nausea and vomiting, chronic gastrointestinal diseases (e.g., inflammatory bowel disease), or significant bowel resection that would preclude adequate absorption
- No uncontrolled intercurrent illness including ongoing or active infection, psychiatric illness, or social situations that would limit compliance with study requirements
PRIOR CONCURRENT THERAPY:
- More than 4 weeks since prior chemotherapy or radiotherapy (6 weeks for nitrosoureas or mitomycin C) and recovered
- No prior AZD6244
- No prior MEK inhibitor
- No HIV-positive patients on combination antiretroviral therapy
- No concurrent medications with the potential to prolong the QT interval
- No concurrent grapefruit or grapefruit juice during AZD6244 administration
- No other concurrent investigational or commercial agents for this cancer
Key Exclusion Criteria:
Additional Study Details
Official Title:
A Phase II Trial of AZD6244 (NSC #741078, IND #77782) in Women With Recurrent Low-Grade Serous Carcinoma of the OvaryAnticipated start date:
5/27/2008Lead Sponsor:
GOGCollaborator(s):
- NCI
Investigator(s):
- Amreen Husain
- Jonathan S. Berek MD, MMS
- Margrit Megumi Juretzka
- Valerie Emi Sugiyama
- Nelson N Teng
- Mallory Zhang
Study Type:
InterventionalPurpose:
TreatmentAllocation:
Non-randomizedMasking:
OpenControl:
noneAssignment:
Single GroupEndpoints:
Safety/EfficacyPrimary Outcomes:
- Tumor response rate (complete and partial response) [ Designated as safety issue: No ]
Secondary Outcomes:
- Progression-free survival [ Designated as safety issue: No ]
- Overall survival [ Designated as safety issue: No ]
- Toxicity as assessed by CTCAE version 3.0 [ Designated as safety issue: Yes ]
- Relationship of tumor response rate with DNA isolation and sequencing of BRAF and ras mutation analysis [ Designated as safety issue: No ]
- Levels of BRAF and ras mutation in the tumor [ Designated as safety issue: No ]
- Protein levels of p-ERK/ERKERK [ Designated as safety issue: No ]
- Pharmacokinetic profile of AZD6244 [ Designated as safety issue: No ]
Total Number to be Enrolled:
71Total Number to be Enrolled at Stanford:
2More Information
Secondary ID(s):
- CDR0000563965
- GOG-0239
- GOG0239
- NCT00551070
Locations & Contacts
Stanford Locations & Contacts:
Stanford University School of Medicine 300 Pasteur Drive Stanford, CA 94305Non-Stanford Locations:
The Stanford website does not have any locations outside of Stanford listed for this trial. You may want to check clinicaltrials.gov for posible additional locations.
This listing was last updated:
8/24/2009PLEASE NOTE:
Study Coordinators and Research Nurses cannot give medical advice over the phone. Telephone numbers are provided for obtaining additional information on specific clinical research trials only. If you have specific questions which require clinical expertise, please call your primary care physician. If you do not have a primary care physician please feel free to call the SHC Physician Referral Service at (800) 756-9000 or send an email.
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