S1201: Combination Chemo for Patients W/Advanced or Metastatic Esophageal, Gastric, or Gastroesophageal Junction Cancer

Conditions

• Adenocarcinoma of the Gastroesophageal Junction
• Esophageal Cancer
• Gastric Cancer

Eligibility Criteria

Sex

ALL

Age

18 Years - 120 Years

Healthy Volunteers

Not accepted

Interventions

• FOLFOX regimen — DRUG
  Given IV. Fluorouracil, oxaliplatin, \& leucovorin calcium.
• docetaxel — DRUG
  30 mg/m\^2, IV over 30 minutes on Day 1,8 of each 21 day cycle.
• fluorouracil — DRUG
  400 mg/m\^2, IV bolus on Day 1 of each 14 day cycle; 2400 mg/m\^2 IV over 46-48 hours on Days 1-2 of each 14 day cycle.
• irinotecan hydrochloride — DRUG
  65 mg/m\^2, IV over 90 minutes on Days 1 \& 8 of every 21 day cycle.
• leucovorin calcium — DRUG
  400 mg/m\^2, IV over 2 hours on Day 1 of every 14 day cycle.
• oxaliplatin — DRUG
  85 mg/m\^2, IV over 2 hours on Day 1 of every 14 day cycle.

Study Details

RATIONALE: Drugs used in chemotherapy, such as oxaliplatin, leucovorin calcium, fluorouracil, irinotecan hydrochloride, and docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Combining more than one drug may kill more tumor cells. It is not yet known which regimen of combination chemotherapy is more effective in treating tumor cells. PURPOSE: This randomized phase II trial studies how well oxaliplatin, leucovorin calcium, and fluorouracil work compared to irinotecan hydrochloride and docetaxel in treating patients with esophageal cancer, gastric cancer, or gastroesophageal junction cancer.

Key Dates

Start date

Feb 29, 2012

Status verified

Oct 2019

Primary completion

Mar 31, 2018

Completion

Sep 19, 2019

Study Design

Enrollment

213 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Arm I
  FOLFOX regimen: Patients receive oxaliplatin IV over 2 hours and leucovorin calcium IV over 2 hours on day 1, and fluorouracil IV over 46-48 hours on days 1-2. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
• Experimental: Arm II
  Patients receive irinotecan hydrochloride IV over 90 minutes and docetaxel IV over 30-60 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measure

Progression-free Survival (PFS) in High-ERCC1 Patients [ Time Frame: Up to 3 years after registration ]

Locations (508)

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