FOLFOX-A in the Treatment of Metastatic or Advanced Unresectable Gastric, Gastro-Esophageal Junction Adenocarcinoma

Conditions:Cancer, Cancer
Therapuetic Areas:Oncology
Age Range:18 - Any
Start Date:September 21, 2017
End Date:June 30, 2020
Contact:Dylan Cregar

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A Phase II Study of FOLFOX Combined With Nab-Paclitaxel (FOLFOX-A) in the Treatment of Metastatic or Advanced Unresectable Gastric, Gastro-Esophageal Junction Adenocarcinoma. Big Ten Cancer Research Consortium: BTCRC-GI15-015

This is an open label, single-arm phase II, multi-institutional trial to evaluate the
efficacy and safety of the combination of nab-paclitaxel and FOLFOX (FOLFOX-A) as first line
therapy for patients diagnosed with histologically-confirmed advanced gastric/GEJ

All patients will receive FOLFOX-A every 14 days of each cycle (1 cycle = 28 days).
Nab-paclitaxel will be given at a dose of 150 mg/m^2 IV over 30 minutes, followed by
oxaliplatin IV 85 mg/m^2 and leucovorin IV 400 mg/m^2 over 2 hours, and 5-FU as a continuous
IV infusion over Day 1 and Day 2 (for a total dose of 2400mg/m^2 over 46-48 hours.).
Radiographic assessment will be performed at baseline and every 8 weeks to evaluate response
to treatment by RECIST Version 1.1 guidelines. Patients may continue to receive treatment
until disease progression or unacceptable toxicity.

Inclusion Criteria:

Subject must meet all of the following applicable inclusion criteria to participate in this

- Written informed consent and HIPAA authorization for release of personal health

- Age ≥ 18 years at the time of consent.

- ECOG Performance Status of 0-1 within 28 days prior to registration.

- Histologically-confirmed advanced or metastatic unresectable gastric carcinoma, or
adenocarcinoma of the gastroesophageal junction.

- Measurable disease according to RECIST v1.1 for solid tumors, within 28 days prior to

- Demonstrate adequate organ function as described below; all screening labs to be
obtained within 28 days prior to registration:

- Bilirubin < 1.5 mg/dL

- Patients must have adequate liver function: AST and ALT < 2.5 x upper limit of
normal, alkaline phosphatase < 2.5 x upper limit of normal, unless bone or liver
metastasis is present (≤5 x upper limit of normal).

- Patients must have adequate bone marrow function: Platelets >100,000 cells/mm^3
(transfusion independent, defined as not receiving platelet transfusions within 7
days prior to laboratory sample), Hemoglobin > 9.0g/dL and ANC > 1,500

- Patients must have adequate renal function: creatinine <1.5 mg/dL or creatinine
clearance ≥60mL/min is recommended; however, institutional norms are acceptable.

- Females of child-bearing potential (defined as a sexually mature woman who (1) has not
undergone hysterectomy [the surgical removal of the uterus] or bilateral oophorectomy
[the surgical removal of both ovaries] or (2) has not been naturally postmenopausal
for at least 24 consecutive months [i.e., has had menses at any time during the
preceding 24 consecutive months]) must:

- Either commit to true abstinence from heterosexual contact (which must be
reviewed on a monthly basis), or agree to use and be able to comply with
effective contraception without interruption 28 days prior to starting IP therapy
(including dose interruptions), and while on study medication or for a longer
period if required by local regulations following the last dose of IP; and

- Have a negative serum pregnancy test (β -hCG) result at screening and agree to
ongoing pregnancy testing prior to each treatment and after the end of study
therapy. This applies even if the subject practices true abstinence from
heterosexual contact.

- Male subjects must practice true abstinence or agree to use a condom during
sexual contact with a pregnant female or a female of childbearing potential while
participating in the study, during dose interruptions and for 6 months following
IP discontinuation, even if he has undergone a successful vasectomy.

Exclusion Criteria:

Subjects meeting any of the criteria below may not participate in the study:

- Prior systemic treatment.

- Her-2 positive gastric tumor.

- Treatment with any investigational products within 28 days prior to study

- Preexisting peripheral neuropathy is not allowed from any cause.

- Known history of Human Immunodeficiency Virus (HIV) or Hepatitis C (baseline testing
is not required).

- Patients with active sepsis or pneumonitis.

- Known active central nervous system (CNS) metastases and/or carcinomatous meningitis.
Subjects with previously treated brain metastases may participate provided they are
stable (without evidence of progression by imaging for at least four weeks prior to
trial registration and any neurologic symptoms have returned to baseline), have no
evidence of new or enlarging brain metastases, and are not using steroids for at least
7 days prior to trial registration.

- Known hypersensitivity to fluorouracil (5-FU), oxaliplatin, or other platinum agents.

- Known hypersensitivity to nab-paclitaxel or any of its excipients.

- Has known dihydropyrimidine dehydrogenase deficiency (DPD) deficiency (testing not

- Ongoing or active infection requiring systemic treatment (must be afebrile for ≥ 48
hours prior to study registration).

- Uncontrolled intercurrent illness including, but not limited to any of the following:

- Symptomatic congestive heart failure

- Unstable angina pectoris

- Cardiac arrhythmia

- Pregnant or breastfeeding (NOTE: breast milk cannot be stored for future use while the
mother is being treated on study).

- Known additional malignancy within the past 3 years. Exceptions include treated
localized basal cell or squamous cell carcinoma of the skin, in situ cervical or
vulvar carcinoma that has undergone potentially curative therapy, superficial bladder
tumors (Ta, Tis & T1), ductal carcinoma in situ (DCIS) of the breast and low grade
prostate cancer (Gleason sore 6). Any cancer curatively treated > 3 years prior to
registration with no clinical evidence of recurrence is permitted.

- Psychiatric illness/social situations that would limit compliance with study

- Any other illness or condition that the treating investigator feels would interfere
with study compliance or would compromise the patient's safety or study endpoints.
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