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
: January 11, 2018
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Stomach Neoplasms Esophageal Neoplasms | Drug: Irinotecan Drug: Trastuzumab Drug: Oxaliplatin Drug: Leucovorin Drug: Fluorouracil | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 65 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 : | May 31, 2018 |
Estimated Study Completion Date : | May 31, 2021 |

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:
Drug: Oxaliplatin
Other Name: Eloxatin®
Drug: Leucovorin
Other Names:
Drug: Fluorouracil
Other Names:
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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:
Drug: Trastuzumab
Other Name: Herceptin®
Drug: Oxaliplatin
Other Name: Eloxatin®
Drug: Leucovorin
Other Names:
Drug: Fluorouracil
Other Names:
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- Objective response rate [ Time Frame: 4 months ]Objective response rate (defined as CR + PR by RECIST 1.1 criteria)
- Progression free survival [ Time Frame: 4 months ]Duration of time from start of treatment to time of progression or death, whichever occurs first.
- 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.
- 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.
- 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).
- 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
- Toxicity and tolerability [ Time Frame: 4 months ]NCI CTCAE v. 4.0 toxicity Grade 3 and Grade 4 laboratory abnormalities will be listed.

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Biopsy-proven and inoperable locally advanced, recurrent, or metastatic cancer of the esophagus, stomach, or gastro-esophageal junction.
- 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.
- Prior single modality radiation therapy is allowed.
- At least 18 years of age.
- ECOG performance status ≤ 2
-
Normal bone marrow and organ function as defined below:
- Absolute neutrophil count ≥ 1,500/mcl
- Platelets ≥ 100,000/mcl
- AST(SGOT)/ALT(SGPT) ≤ 2.5 x IULN
- Creatinine ≤ IULN OR creatinine clearance ≥ 60 mL/min/1.73 m2 for patients with creatinine levels above institutional normal
- LVEF ≥ 50%
- 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.
- Ability to understand and willingness to sign an IRB approved written informed consent document (legally authorized representative is allowed).
- 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:
- Chemotherapy in the 6 months prior to registration.
- 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)
- Receiving any other investigational agents at the time of registration.
- 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.
- A history of allergic reactions attributed to compounds of similar chemical or biologic composition to the agents used in the study.
- Previous therapy for metastatic gastroesophageal cancer. Previous perioperative chemotherapy is allowed as long as the duration without treatment has been greater than 6 months..
- A history of congestive heart failure, transmural myocardial infarction, symptomatic valvular disease, or high-risk arrhythmia.
- 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.
- Pregnant and/or breastfeeding. Patient must have a negative urine pregnancy test within 14 days of study entry.
- 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.

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
Contact: Haeseong Park, M.D. | 314-454-5102 | haeseongpark@wustl.edu | |
Contact: Kalin Guebert | 314-747-8085 | guebertk@wustl.edu |
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. |
Principal Investigator: | Haeseong Park, M.D. | Washington University School of Medicine |
Additional Information:
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: | January 11, 2018 |
Last Verified: | January 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 |