Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03283761
Recruitment Status : Recruiting
First Posted : September 14, 2017
Last Update Posted : August 14, 2019
Sponsor:
Collaborators:
Celgene Corporation
Big Ten Cancer Research Consortium
Information provided by (Responsible Party):
Al B. Benson, III, MD, Big Ten Cancer Research Consortium

Tracking Information
First Submitted Date  ICMJE September 13, 2017
First Posted Date  ICMJE September 14, 2017
Last Update Posted Date August 14, 2019
Actual Study Start Date  ICMJE September 21, 2017
Estimated Primary Completion Date June 30, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 13, 2017)
Overall Objective Response Rate [ Time Frame: 2 years ]
partial or complete response of FOLFOX combined with nab-paclitaxel (FOLFOX-A) in patients with advanced gastric, gastroesophageal junction adenocarcinoma
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03283761 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 13, 2017)
  • Overall Survival (OS) [ Time Frame: 2 years ]
    will be estimated using the method of Kaplan-Meier and univariate testing will be done via the log rank test (median time to event)
  • Progression-Free Survival (PFS) [ Time Frame: 2 years ]
    will be estimated using the method of Kaplan-Meier and univariate testing will be done via the log rank test (median time to event)
  • Time to Progression (TTP) [ Time Frame: 2 years ]
    will be estimated using the method of Kaplan-Meier and univariate testing will be done via the log rank test (median time to event)
  • Best Overall Response Rate (ORR) [ Time Frame: 2 years ]
    will be summarized by count and percent of subjects with each ordinal response analyzed by Cochran-Mantel-Hanzel test
  • Best Disease Control Rate (DCR) [ Time Frame: 2 years ]
    will be summarized by count and percent of subjects with each ordinal response analyzed by Cochran-Mantel-Hanzel test
  • Adverse Events [ Time Frame: 2 years ]
    grade 3 and 4 adverse events defined by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 4
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE FOLFOX-A in the Treatment of Metastatic or Advanced Unresectable Gastric, Gastro-Esophageal Junction Adenocarcinoma
Official Title  ICMJE 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
Brief Summary 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 adenocarcinoma.
Detailed Description 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Masking Description:
Open-Label
Primary Purpose: Treatment
Condition  ICMJE
  • Gastro-Esophageal Junction Adenocarcinoma
  • Gastric Cancer
Intervention  ICMJE
  • Drug: Nab-paclitaxel 150 mg/m^2
    Stage I (N=12), every 14 days Stage II (N= 25), every 14 days
    Other Name: Abraxane®
  • Drug: Oxaliplatin 85 mg/m^2
    Stage I (N= 12), every 14 days Stage II (N= 25), every 14 days
    Other Name: Eloxatin
  • Drug: 5-FU 1200 mg/m^2 x 2 D
    Stage I (N= 12), every 14 days Stage II (N= 25), every 14 days
    Other Names:
    • Adrucil
    • Fluorouracil
  • Drug: Leucovorin 400 mg/m^2
    Stage I (N= 12), every 14 days Stage II (N= 25), every 14 days
Study Arms  ICMJE Experimental: Treatment Arm
All patients in Stage I (N=12) and Stage II (N=25) 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.
Interventions:
  • Drug: Nab-paclitaxel 150 mg/m^2
  • Drug: Oxaliplatin 85 mg/m^2
  • Drug: 5-FU 1200 mg/m^2 x 2 D
  • Drug: Leucovorin 400 mg/m^2
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: September 13, 2017)
39
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 30, 2021
Estimated Primary Completion Date June 30, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

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

  • Written informed consent and HIPAA authorization for release of personal health information.
  • 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 registration.
  • 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 cells/mm^3.
    • 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 registration.
  • 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 required).
  • 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 requirements.
  • 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Dylan Cregar 317-634-5842 ext 38 dcregar@hoosiercancer.org
Contact: Al B. Benson,, MD 312-695-6180 a-benson@northwestern.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03283761
Other Study ID Numbers  ICMJE BTCRC-GI15-015
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Al B. Benson, III, MD, Big Ten Cancer Research Consortium
Study Sponsor  ICMJE Al B. Benson, III, MD
Collaborators  ICMJE
  • Celgene Corporation
  • Big Ten Cancer Research Consortium
Investigators  ICMJE
Study Chair: Al B. Benson, MD Big Ten Cancer Research Consortium
PRS Account Big Ten Cancer Research Consortium
Verification Date August 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP