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Combination Chemotherapy in Treating Patients With Advanced Stomach, Gastroesophageal, or Esophageal Cancer (FOLFIRINOX)

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ClinicalTrials.gov Identifier: NCT01928290
Recruitment Status : Recruiting
First Posted : August 23, 2013
Last Update Posted : May 7, 2018
Sponsor:
Information provided by (Responsible Party):
Washington University School of Medicine

Study Description
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Brief Summary:
This phase II trial studies how well combination chemotherapy works in treating patients with advanced stomach, gastroesophageal, or esophageal cancer. Drugs used in chemotherapy, such as irinotecan hydrochloride, oxaliplatin, leucovorin calcium, and fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.

Condition or disease Intervention/treatment Phase
Stomach Neoplasms Esophageal Neoplasms Drug: Irinotecan Drug: Trastuzumab Drug: Oxaliplatin Drug: Leucovorin Drug: Fluorouracil Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 67 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Study of FOLFIRINOX Chemotherapy for Treatment of Advanced Gastric, Gastro-esophageal Junction, and Esophageal Tumors
Actual Study Start Date : November 8, 2013
Estimated Primary Completion Date : September 30, 2018
Estimated Study Completion Date : May 31, 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: FOLFIRINOX

Irinotecan 180 mg/m2 IV on Days 1 & 15.

Oxaliplatin 85 mg/m2 IV on Days 1 & 15.

Leucovorin 400 mg/m2 IV on Days 1 & 15.

Flurorouracil 400 mg/m2 bolus and 2400 mg/m2 CIVI over 46 hours beginning on Day 1 and Day 15.

 Drug: Irinotecan
Other Names:
  • Camptosar®
  • CPT-11

Drug: Oxaliplatin
Other Name: Eloxatin®

Drug: Leucovorin
Other Names:
  • Wellcovorin® I.V.
  • citrovorum factor

Drug: Fluorouracil
Other Names:
  • folinic acid
  • 5-formyl tetrahydrofolate
  • Adrucil® Injection
  • 5-Fluorouracil
  • 5-FU
Experimental: FOLFIRINOX and Trastuzumab

Trastuzumab 8 mg/kg on Cycle 1 Day 1 then 4 mg/kg on Day 15 and Day 1 of all future cycles.

Irinotecan 180 mg/m2 IV on Days 1 & 15.

Oxaliplatin 85 mg/m2 IV on Days 1 & 15.

Leucovorin 400 mg/m2 IV on Days 1 & 15.

Flurorouracil 400 mg/m2 bolus and 2400 mg/m2 CIVI over 46 hours beginning on Day 1 and Day 15.

 Drug: Irinotecan
Other Names:
  • Camptosar®
  • CPT-11

Drug: Trastuzumab
Other Name: Herceptin®

Drug: Oxaliplatin
Other Name: Eloxatin®

Drug: Leucovorin
Other Names:
  • Wellcovorin® I.V.
  • citrovorum factor

Drug: Fluorouracil
Other Names:
  • folinic acid
  • 5-formyl tetrahydrofolate
  • Adrucil® Injection
  • 5-Fluorouracil
  • 5-FU


Outcome Measures
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Primary Outcome Measures :
  1. Objective response rate [ Time Frame: 4 months ]
    Objective response rate (defined as CR + PR by RECIST 1.1 criteria)


Secondary Outcome Measures :
  1. Progression free survival [ Time Frame: 4 months ]
    Duration of time from start of treatment to time of progression or death, whichever occurs first.

  2. Time to progression (TTP) [ Time Frame: 4 months ]
    Duration of time from start of treatment to time of progression. Progression 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 5 mm.

  3. Overall survival (OS) [ Time Frame: 4 months ]
    Overall survival is defined as the time interval from date of diagnosis to date of death from any cause.

  4. Clinical benefit rate [ Time Frame: up to 3 years ]
    Clinical benefit rate is the percentage of combined patients who have achieved complete response (CR), partial response (PR), and stable disease (SD).

  5. Duration of Response [ Time Frame: up to 3 years ]
    Time measurement criteria are met for CR or PR (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented

  6. Toxicity and tolerability [ Time Frame: 4 months ]
    NCI CTCAE v. 4.0 toxicity Grade 3 and Grade 4 laboratory abnormalities will be listed.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Biopsy-proven and inoperable locally advanced, recurrent, or metastatic cancer of the esophagus, stomach, or gastro-esophageal junction.
  2. Measurable disease defined as lesions that can be accurately measured in at least one dimension (longest diameter to be recorded) as ≥10 mm with CT scan, as ≥20 mm by chest x-ray, or ≥10 mm with calipers by clinical exam.
  3. Prior single modality radiation therapy is allowed.
  4. At least 18 years of age.
  5. ECOG performance status ≤ 2

  6. Normal bone marrow and organ function as defined below:

    1. Absolute neutrophil count ≥ 1,500/mcl
    2. Platelets ≥ 100,000/mcl
    3. AST(SGOT)/ALT(SGPT) ≤ 2.5 x IULN
    4. Creatinine ≤ IULN OR creatinine clearance ≥ 60 mL/min/1.73 m2 for patients with creatinine levels above institutional normal
    5. LVEF ≥ 50%
  7. Women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control, abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she must inform her treating physician immediately.
  8. Ability to understand and willingness to sign an IRB approved written informed consent document (legally authorized representative is allowed).
  9. Patients already receiving treatment with FOLFIRINOX +/- trastuzumab may participate in the study and have their data collected retrospectively if they met inclusion criteria at the start of therapy and sign consent for study participation moving forward.

Exclusion Criteria:

  1. Chemotherapy in the 6 months prior to registration.
  2. Any active malignancy within 3 years that may alter the course of esophageal cancer (Apparently cured localized malignancy or advanced, but indolent malignancy with significantly more favorable prognosis are allowed)
  3. Receiving any other investigational agents at the time of registration.
  4. Known untreated brain metastases. These patients must be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events.
  5. A history of allergic reactions attributed to compounds of similar chemical or biologic composition to the agents used in the study.
  6. Previous therapy for metastatic gastroesophageal cancer. Previous perioperative chemotherapy is allowed as long as the duration without treatment has been greater than 6 months..
  7. A history of congestive heart failure, transmural myocardial infarction, symptomatic valvular disease, or high-risk arrhythmia.
  8. 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.
  9. Pregnant and/or breastfeeding. Patient must have a negative urine pregnancy test within 14 days of study entry.
  10. Known HIV-positivity and on combination antiretroviral therapy because of the potential for pharmacokinetic interactions with trastuzumab. In addition, these patients are at increased risk of lethal infections when treated with marrow-suppressive therapy. Appropriate studies will be undertaken in patients receiving combination antiretroviral therapy when indicated.

Inclusion of Women and Minorities

Both men and women and members of all races and ethnic groups are eligible for this trial.

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01928290


Contacts
Contact: Haeseong Park, M.D. 314-454-5102 haeseongpark@wustl.edu
Contact: Kalin Guebert 314-747-8085 guebertk@wustl.edu

Locations
United States, Missouri
Washington University School of Medicine Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Haeseong Park, M.D.    314-454-5102    haeseongpark@wustl.edu   
Contact: Kalin Guebert    314-747-8085    guebertk@wustl.edu   
Principal Investigator: Haeseong Park, M.D.         
Sub-Investigator: Christopher Maher, Ph.D.         
Sub-Investigator: Joel Picus, M.D.         
Sub-Investigator: Robert Pufahl, Ph.D.         
Sub-Investigator: Caron Rigden, M.D.         
Sub-Investigator: Rama Suresh, M.D.         
Sub-Investigator: Benjamin Tan, M.D.         
Sub-Investigator: Andrea Wang-Gillam, M.D., Ph.D.         
Sub-Investigator: Seth Crosby, M.D.         
Sponsors and Collaborators
Washington University School of Medicine
Investigators
Principal Investigator: Haeseong Park, M.D. Washington University School of Medicine
More Information
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Additional Information:
Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine  This link exits the ClinicalTrials.gov site

Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT01928290     History of Changes
Other Study ID Numbers: 201309035
First Posted: August 23, 2013    Key Record Dates
Last Update Posted: May 7, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Esophageal Neoplasms
Neoplasms
Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Head and Neck Neoplasms
Esophageal Diseases
Oxaliplatin
Irinotecan
Trastuzumab
Fluorouracil
 Leucovorin
Levoleucovorin
Tetrahydrofolates
Formyltetrahydrofolates
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antimetabolites
Antimetabolites, Antineoplastic
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs