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Gastro-Esophageal Junction AdenocarcinomaPhase 2NCT03283761

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

A Phase 2 study testing Nab-paclitaxel 150 mg/m^2, Oxaliplatin 85 mg/m^2 and 5-FU 1200 mg/m^2 x 2 D in people with Gastro-Esophageal Junction Adenocarcinoma and Gastric Cancer, run by Al B. Benson, III, MD at 8 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Nab-paclitaxel 150 mg/m^2, Oxaliplatin 85 mg/m^2 and 5-FU 1200 mg/m^2 x 2 D
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
39 participants
Where
8 sitesUnited States
Study dates
21 Sep 2017to 16 Jan 2023
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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. NOTE: HIPAA authorization may be included in the informed consent or obtained separately.
  • 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.
  • Prior neoadjuvant or adjuvant chemotherapy, hormonal therapy, immunotherapy, radiation or chemoradiotherapy must have been completed at least 6 months prior to documented recurrence or metastatic disease. NOTE: patients must not have received previous systemic treatment for metastatic disease.
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  • Evaluable 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/mm3 (transfusion independent, defined as not receiving platelet transfusions within 7 days prior to laboratory sample), Hemoglobin > 9.0g/dL and ANC > 1,500 cells/mm3.
  • 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 investigational product (IP), and while on study medication (including dose interruptions) and for 30 days 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.
  • NOTE: True abstinence is acceptable when this is in line with the preferred and usual lifestyle of the subject. [Periodic abstinence (eg, calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception].

Who cannot join

  • Subjects meeting any of the criteria below may not participate in the study:
  • 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
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  • 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.
  • History of slowly progressive dyspnea and unproductive cough, or pulmonary conditions such as sarcoidosis, silicosis, idiopathic pulmonary fibrosis, hypersensitivity pneumonitis or multiple allergies. See section 6.5.1.
  • 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

Trial locations and contacts

8 sites in 1 country.

8 sites in 1 country

United States8 sites

  • Northwestern University Feinberg School of Medicine

    Chicago, Illinois, 60611

  • Univeristy of Illinois Cancer Center

    Chicago, Illinois, 60612

  • University of Iowa Hospitals and Clinics

    Iowa City, Iowa, 52242

  • Northwestern Medicine Lake Forest Hospital

    Lake Forest, Illinois, 60045

  • Michigan State University

    Lansing, Michigan, 48910

  • University of Wisconsin

    Madison, Wisconsin, 53705

  • University of Minnesota

    Minneapolis, Minnesota, 55455

  • Rutgers Cancer Institute of New Jersey

    New Brunswick, New Jersey, 08903

Other trials in United States

About this study

Official title: 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 adenocarcinoma.

Read the detailed description

All patients will receive FOLFOX-A on days 1 and 15 of each cycle (1 cycle = 28 days). Nab-paclitaxel will be given at a dose of 150 mg/m2 IV over 30 minutes, followed by oxaliplatin IV 85 mg/m2 and leucovorin IV 400 mg/m2 over 2 hours, and 5-FU as a continuous IV infusion over Day 1 and Day 2 (for a total dose of 2400mg/m2 over 46-48 hours.). Radiographic assessment will be performed at baseline and every other cycle (starting with Cycle 3) to evaluate response to treatment by RECIST Version 1.1 guidelines. Patients may continue to receive treatment until disease progression or unacceptable toxicity.

Being tested
Nab-paclitaxel 150 mg/m^2, Oxaliplatin 85 mg/m^2, 5-FU 1200 mg/m^2 x 2 D, Leucovorin 400 mg/m^2
Keywords
FOLFOX, Nab-Paclitaxel
Medical subject headings
Stomach Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Nab-paclitaxel 150 mg/m^2Drug

    Also called Abraxane®

    Stage I (N=12), on day 1 and day 15 Stage II (N= 25), on day 1 and day 15

  • Oxaliplatin 85 mg/m^2Drug

    Also called Eloxatin

    Stage I (N= 12), on day 1 and day 15 Stage II (N= 25), on day 1 and day 15

  • 5-FU 1200 mg/m^2 x 2 DDrug

    Also called Adrucil, Fluorouracil

    Stage I (N= 12), on day 1 and day 15-16 Stage II (N= 25),on day 1 and day 15-16

  • Leucovorin 400 mg/m^2Drug

    Stage I (N= 12),on day 1 and day 15 Stage II (N= 25), on day 1 and day 15

Study groups in NCT03283761
Study groupRoleWhat they receive
Treatment ArmExperimentalAll patients in Stage I (N=12) and Stage II (N=25) will receive FOLFOX-A on days 1 and 15 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 other cycle (starting with Cycle 3) to evaluate response to treatment by RECIST Version 1.1 guidelines. Patients may continue to receive treatment until disease progression or unacceptable toxicity.
Receives: 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

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Objective Response Rate

    Objective response rate will be calculated by combining the number of subjects who achieve complete response and partial response per RECIST 1.1 criteria.Partial response is defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. Complete response is defined as disappearance of all target lesions. Any pathological lymph nodes(whether target or non-target) must have reduction in short axis to <10 mm.

    Measured: From C1D1 until death or up to a maximum of 36 months

Secondary outcomes (6)

  1. Overall Survival (OS)

    Overall survival is defined by the date of the start of treatment to date of death from any cause.

    Measured: From C1D1 until death or up to a maximum of 52 months

  2. Progression-Free Survival (PFS)

    Progression free survival is defined as the time of treatment initiation until the criteria for disease progression per RECIST1.1 are met or until the date of a death event (any cause). Progressive disease is defined as at least a 20% increase in the sum of the diameters of target lesions,taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5mm. (Note: the appearance of one or more new lesions is also considered progressions).

    Measured: From C1D1 until death or up to a maximum of 36 months

  3. Time to Progression (TTP)

    Time to progression is defined as the time from registration date until the criteria for disease progression per RECIST1.1 are met. Progressive disease is defined as at least a 20% increase in the sum of the diameters of target lesions,taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5mm. (Note: the appearance of one or more new lesions is also considered progressions).

    Measured: From C1D1 until PD or up to a maximum of 36 months

  4. Number of Subjects Achieve Best Overall Response of CR, PR, SD and PD

    Partial response is defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. Complete response is defined as disappearance of all target lesions. Any pathological lymph nodes(whether target or non-target) must have reduction in short axis to <10 mm. Stable disease is defined as neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study. Progressive disease is defined as at least a 20% increase in the sum of the diameters of target lesions,taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5mm. (Note: the appearance of one or more new lesions is also considered progressions).

    Measured: From C1D1 until PD or up to a maximum of 36 months

  5. Disease Control Rate (DCR)

    The disease control rate is the proportion of all subjects with stable disease (SD) , or partial response (PR), or complete response (CR) according to RECIST 1.1, from the start of treatment until disease progression/recurrence (taking as reference for progressive disease the smallest measurements recorded since the start of treatment). Partial response is defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. Complete response is defined as disappearance of all target lesions. Any pathological lymph nodes(whether target or non-target) must have reduction in short axis to <10 mm. Stable disease is defined neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.

    Measured: From C1D1 until PD or up to a maximum of 36 months

  6. Safety and Toxicity Profile of the Combination of Nab-paclitaxel and FOLFOX

    Safety and tolerability of abemaciclib in the combination of nab-paclitaxel and FOLFOX in patients with metastatic or advanced unresectable gastric, gastro-esophageal junction adenocarcinoma., assessed by NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.

    Measured: From C1D1 until death or up to a maximum of 52 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Sep 2017
  2. Study start21 Sep 2017
  3. Primary completion27 Dec 2022
  4. Study completion16 Jan 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
39 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03283761
Sponsor's protocol ID
BTCRC-GI15-015
Status last verified
Jan 2024
First submitted
13 Sep 2017
Last updated
6 Feb 2024
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Nab-paclitaxel 150 mg/m^2, Oxaliplatin 85 mg/m^2 and 5-FU 1200 mg/m^2 x 2 D in people with Gastro-Esophageal Junction Adenocarcinoma and Gastric Cancer, run by Al B. Benson, III, MD at 8 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 17 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 6 Feb 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective Response Rate (time frame: From C1D1 until death or up to a maximum of 36 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03283761.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2024.

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