Clinical Trial Details
Braintumor Website

[Information provided by: ClinicalTrials.gov, which provides patients, family members, and members of the public easy and free access to information on clinical studies for a wide range of diseases and conditions.]

NCT02122185 : Metformin Hydrochloride and Combination Chemotherapy in Treating Patients With Stage III-IV Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
PhasePhase 2
AgesMin: 18 Years Max: 77 Years
Eligibility
Inclusion Criteria:

- ELIGIBILITY CRITERIA FOR PRE-REGISTRATION

- A reasonable suspicion of ovarian cancer by the treating oncologist is required,
evidenced by abdominal carcinomatosis, omental caking, pleural effusions or ascites
AND an elevated CA125 > 250 OR CA125:carcinoembryonic antigen (CEA) ratio > 25 OR
CA125 =< 250 with no evidence of gastrointestinal (GI) cancer

- Eastern Cooperative Oncology Group (ECOG) performance status =< 2

- Leukocytes >= 3,000/mcL

- Absolute neutrophil count >= 1,500/mcL

- Platelets >= 100,000/mcL

- Total bilirubin =< upper normal institutional limits (except for patients with
Gilbert's disease who are eligible despite elevated serum bilirubin level)

- Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase
[SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT])
=< 2.0 × institutional upper limit of normal

- Creatinine =< institutional upper limit of normal (ULN) OR creatinine clearance >= 60
mL/min/1.73 m^2

- Blood glucose =< 126 mg/dL fasting or =< 140 mg/dL nonfasting

- Signed written pre-registration informed consent document

- ELIGIBILITY CRITERIA FOR REGISTRATION: subjects must have histologically confirmed
carcinoma consistent with ovarian, fallopian tube, or primary peritoneal carcinoma
(any of these three are referred to in this protocol as "ovarian cancer [OvCA]" OR a
cytological diagnosis of carcinoma); the following histologic subtypes are included:
serous, endometrioid, undifferentiated, clear cell, mixed, transitional, malignant
Brenner tumor or adenocarcinoma not otherwise specified (NOS); subjects eligible for
this study may be in one of three surgical categories: status post primary debulking
surgery; undergoing neoadjuvant chemotherapy at a site not participating in
correlative tissue collection sub study OR undergoing neoadjuvant chemotherapy at a
site participating in correlative tissue collection sub study

- ELIGIBILITY CRITERIA FOR REGISTRATION: subjects undergoing primary debulking surgery
must have stage III or IV disease and have undergone surgery to include, at a
minimum, removal of the uterus, ovaries and fallopian tubes; these patients may be
optimally debulked (less than 1 cm residual disease) but must have grossly visible
macroscopic residual disease OR be suboptimally debulked

- ELIGIBILITY CRITERIA FOR REGISTRATION: subjects for whom neoadjuvant chemotherapy
followed by interval cytoreductive surgery is planned must have fine needle aspirate
(FNA) or other cytology showing adenocarcinoma OR core biopsies OR surgically
directed biopsies showing adenocarcinoma AND CA125 over 250 OR CA125:CEA ratio > 25
OR CA =< 250 with no evidence of GI cancer; they should have presumed stage III or IV
disease, generally based on abdominal carcinomatosis, omental caking, pleural
effusions or ascites

- ELIGIBILITY CRITERIA FOR REGISTRATION: the subject and her physician must agree to
six cycles of one of the standard of care regimens allowed on this protocol; these
regimens (starting dosage) include:

- IV paclitaxel 175 mg/m^2 and carboplatin area under the curve (AUC) 5-6 every 21
days

- IV docetaxel 75 mg/m^2 and carboplatin AUC 5-6 every 21 days

- IV paclitaxel 80 mg/m^2 day 1, 8, and 15 and carboplatin AUC 5-6 day 1 every 21
days

- Use of granulocyte colony stimulating factor is permitted, but additional
chemotherapy agents (e.g. gemcitabine) or biologic agents (e.g.
bevacizumab) are not; dose modifications for patients over age 70 are
allowable as outlined in the protocol

- ELIGIBILITY CRITERIA FOR REGISTRATION: ECOG performance status =< 2

- ELIGIBILITY CRITERIA FOR REGISTRATION: Leukocytes >= 3,000/mcL

- ELIGIBILITY CRITERIA FOR REGISTRATION: absolute neutrophil count >= 1,500/mcL

- ELIGIBILITY CRITERIA FOR REGISTRATION: platelets >= 100,000/mcL

- ELIGIBILITY CRITERIA FOR REGISTRATION: total bilirubin =< upper normal institutional
limits (except for patients with Gilbert's disease who are eligible despite elevated
serum bilirubin level)

- ELIGIBILITY CRITERIA FOR REGISTRATION: AST(SGOT)/ALT(SGPT) =< 2.0 × institutional
upper limit of normal

- ELIGIBILITY CRITERIA FOR REGISTRATION: creatinine =< OR institutional ULN OR
creatinine clearance >= 60 mL/min/1.73 m^2

- ELIGIBILITY CRITERIA FOR REGISTRATION: blood glucose =< 126 mg/dL fasting or =< 140
mg/dL nonfasting

- ELIGIBILITY CRITERIA FOR REGISTRATION: women of child-bearing potential must agree to
use an effective method of birth control on trial, as the safety of metformin in
pregnancy has not been established; an effective method of birth control includes
surgical sterilization of woman or her partner, abstinence, or two barrier methods
(e.g. condom plus diaphragm); hormonal methods of birth control are not permitted on
this study

- ELIGIBILITY CRITERIA FOR REGISTRATION: ability to understand and the willingness to
sign a written informed consent document

Exclusion Criteria:

- EXCLUSION CRITERIA FOR PRE-REGISTRATION

- Subjects with known diabetes and those taking metformin, sulfonylureas,
thiazolidinediones or insulin for any reason

- Patients who are receiving any other investigational agents

- Subjects with comorbidities that would limit their two year survival for reasons
other than ovarian cancer

- Concurrent active invasive malignancy or one previously diagnosed with a greater than
30% chance of recurrence in the next two years

- History of allergic reactions attributed to compounds of similar chemical or biologic
composition to metformin

- Subjects must not have conditions associated with increased risk of
metformin-associated lactic acidosis, including New York Heart Association class III
or IV congestive heart failure, history of acidosis of any type, alcoholic liver
disease, or habitual intake of 3 or more alcoholic beverages per day

- Uncontrolled intercurrent illness including, but not limited to, ongoing or active
major infection, unstable angina pectoris, or psychiatric illness/social situations
that would limit compliance with study requirements

- Pregnant or nursing women are excluded from this study

- EXCLUSION CRITERIA FOR REGISTRATION: mucinous adenocarcinoma, borderline tumors

- EXCLUSION CRITERIA FOR REGISTRATION: subjects who will undergo intraperitoneal
chemotherapy

- EXCLUSION CRITERIA FOR REGISTRATION: subjects receiving neoadjuvant chemotherapy for
whom interval debulking surgery (assuming adequate response to therapy) is not
planned

- EXCLUSION CRITERIA FOR REGISTRATION: subjects receiving chemotherapy regimens not
specified in the inclusion criteria

- EXCLUSION CRITERIA FOR REGISTRATION: subjects should not be participating in other
clinical trials of interventions designed to reduce risk of ovarian cancer recurrence
or plan to receive off -protocol maintenance therapy (e.g. paclitaxel or bevacizumab)

- EXCLUSION CRITERIA FOR REGISTRATION: subjects with known diabetes, fasting glucose
over 126 mg/dL or random glucose over 140 mg/dL and those taking metformin,
sulfonylureas, thiazolidenediones or insulin for any reason

- EXCLUSION CRITERIA FOR REGISTRATION: patients who are receiving any other
investigational agents

- EXCLUSION CRITERIA FOR REGISTRATION: subjects with comorbidities which would lead to
a clinical expectation that they will not survive two years for reasons other than
ovarian cancer

- EXCLUSION CRITERIA FOR REGISTRATION: concurrent active invasive malignancy or one
previously diagnosed with a greater than 30% chance of recurrence in the next two
years

- EXCLUSION CRITERIA FOR REGISTRATION: history of allergic reactions attributed to
compounds of similar chemical or biologic composition to metformin

- EXCLUSION CRITERIA FOR REGISTRATION: subjects must not have conditions associated
with increased risk of metformin-associated lactic acidosis, including New York Heart
Association class III or IV congestive heart failure, history of acidosis of any
type, alcoholic liver disease, or habitual intake of 3 or more alcoholic beverages
per day

- EXCLUSION CRITERIA FOR REGISTRATION: uncontrolled intercurrent illness including, but
not limited to, ongoing or active infection, symptomatic congestive heart failure,
unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social
situations that would limit compliance with study requirements

- EXCLUSION CRITERIA FOR REGISTRATION: pregnant or nursing women are excluded from this
study
LinksPermanent Link to THIS page: https://virtualtrials.com/nct/display1trial.cfm?nct=NCT02122185      |      Link to official Clinicaltrials.gov listing
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