Neoplasms

Digestive System Diseases

All Conditions

Rare Diseases

Stomach Neoplasms

Esophageal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Stomach Diseases

Head and Neck Neoplasms

Esophageal Diseases

Stomach Cancer

Esophageal Cancer

Antineoplastic Agents

All Drugs and Chemicals

Micronutrients

Hematinics

Vitamins

Irinotecan

Trastuzumab

Leucovorin

Fluorouracil

Levoleucovorin

Oxaliplatin

Folic Acid

Folfirinox

Tetrahydrofolates

Formyltetrahydrofolates

Antimetabolites

Immunosuppressive Agents

Immunologic Factors

Antineoplastic Agents, Immunological

Topoisomerase I Inhibitors

Enzyme Inhibitors

Antidotes

Protective Agents

Vitamin B Complex

Trace Elements

Folinic Acid

Folate

Vitamin B9

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.

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

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.

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

Haeseong Park, M.D.

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.

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

Phase II Study of FOLFIRINOX Chemotherapy for Treatment of Advanced Gastric, Gastro-esophageal Junction, and Esophageal Tumors

* Objective response (defined as complete response (CR) + partial response (PR) by RECIST 1.1 criteria)
* CR: Disappearance of all target lesions, non-target lesions, and normalization of tumor marker level. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm.
* PR: At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.

Duration of time from start of treatment to time of progression or death, whichever occurs first.

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 is defined as the time interval from date of diagnosis to date of death from any cause.

* Clinical benefit rate is the percentage of combined patients who have achieved complete response (CR), partial response (PR), and stable disease (SD)
* CR: Disappearance of all target lesions, non-target lesions, and normalization of tumor marker level. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm
* PR: At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters
* SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.

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

Washington University School of Medicine

For purposes of this study, abnormal lab values will only be collected and documented if they are clinically significant. Once a patient begins maintenance therapy, adverse events will no longer be collected and documented.

Arm A: FOLFIRINOX (HER2-negative)

Arm B: FOLFIRINOX & Trastuzumab (HER2-positive)

Total

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

Number of Participants With an Objective Response

Progression Free Survival

Time to Progression (TTP)

Overall Survival (OS)

Clinical Benefit Rate

Duration of Response

Anemia

Febrile neutropenia

Anal Fistula

Diarrhea

Hematemesis

Nausea

Peripheral ischemia

Vomiting

Fatigue

Laparoscopy surgery

Pain

Sepsis

Lung infection

Pneumonia

Hypernatremia

Neutrophil count decreased

Platelet count decreased

Anorexia

Dehydration

Hypokalemia

Back pain

Peripheral sensory neuropathy

Syncope

Dyspnea

Pleural embolism

Skin infection

Thromboembolic event

Abdominal pain

Enterocolitis

Hemorrhoids

G-tube infection

Neutropenic entercolitis

Alkaline phosphatase increased

Toxicity and Tolerability (Arm A and Arm B) as Measured by the Number of Participants With Grade 3 or Higher Adverse Events

Overall Study

Spots Global Cancer Trial Database for Combination Chemotherapy in Treating Patients With Advanced Stomach, Gastroesophageal, or Esophageal Cancer

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

Useful links and downloads for this trial