NCT01498289|CompletedPhase 2ResultsDMC

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

A Randomized Phase II Pilot Study Prospectively Evaluating Treatment for Patients Based on ERCC1(Excision Repair Cross-Complementing 1) for Advanced/Metastatic Esophageal, Gastric or Gastroesophageal Junction (GEJ) Cancer

SWOG Cancer Research Network ClinicalTrials.gov

Compare

3 other identifiers

S1201U10CA032102NCI-2012-00096

Study Type

interventional

Target

213

Locations

1 country

Sites

508

Timeline

RegisteredDec 2011

StartedFeb 2012

CompletionSep 2019

Brief Summary

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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

213

participants targeted

Target at P75+ for phase_2

Timeline

Completed

Started Feb 2012

Longer than P75 for phase_2

Geographic Reach

1 country

508 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

7.6 years study duration

First Submitted

Initial submission to the registry

December 22, 2011

Completed

1 day until next milestone

First Posted

Study publicly available on registry

December 23, 2011

Completed

1 month until next milestone

Study Start

First participant enrolled

February 1, 2012

Completed

6.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2018

Completed

1.5 years until next milestone

Results Posted

Study results publicly available

August 29, 2019

Completed

21 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 19, 2019

Completed

Last Updated

November 7, 2019

Status Verified

October 1, 2019

Enrollment Period

6.1 years

First QC Date

December 22, 2011

Results QC Date

July 15, 2019

Last Update Submit

October 25, 2019

Conditions

Adenocarcinoma of the Gastroesophageal Junction Esophageal Cancer Gastric Cancer

Keywords

recurrent esophageal cancerstage IV esophageal cancerrecurrent gastric cancerstage IV gastric canceradenocarcinoma of the gastroesophageal junctionstage IIIB gastric cancerstage IIIC gastric cancerstage IIIB esophageal cancerstage IIIC esophageal canceradenocarcinoma of the esophagusadenocarcinoma of the stomach

Outcome Measures

Primary Outcomes (3)

Progression-free Survival (PFS) in High-ERCC1 Patients
Progression-free survival is the length of time between protocol registration and disease progression or death, whichever occurs first.
Up to 3 years after registration
PFS in Low-ERCC1 Participants
Progression-free survival is the length of time between protocol registration and disease progression or death, whichever occurs first.
Up to 3 years after registration
Overall Survival (OS)
OS is the length of time between protocol registration and patient death
Up to 3 years after registration

Secondary Outcomes (3)

Overall Response Rate (ORR)
Up to 3 years after registration
PFS Variation by ERCC1
up to 3 years after registration
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Duration of treatment and follow up until death or 3 years post registration

Study Arms (2)

Arm I

EXPERIMENTAL

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.

Drug: FOLFOX regimenDrug: fluorouracilDrug: leucovorin calciumDrug: oxaliplatin

Arm II

EXPERIMENTAL

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.

Drug: docetaxelDrug: irinotecan hydrochloride

Interventions

FOLFOX regimenDRUG

Given IV. Fluorouracil, oxaliplatin, \& leucovorin calcium.

Arm I

docetaxelDRUG

30 mg/m\^2, IV over 30 minutes on Day 1,8 of each 21 day cycle.

Also known as: Taxotere, RP56976, NSC-628503

Arm II

fluorouracilDRUG

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.

Also known as: 5-fluorouracil, 5-FU, NSC-19893

Arm I

irinotecan hydrochlorideDRUG

65 mg/m\^2, IV over 90 minutes on Days 1 \& 8 of every 21 day cycle.

Also known as: CPT-11, NSC-616348

Arm II

leucovorin calciumDRUG

400 mg/m\^2, IV over 2 hours on Day 1 of every 14 day cycle.

Also known as: NSC-3590

Arm I

oxaliplatinDRUG

85 mg/m\^2, IV over 2 hours on Day 1 of every 14 day cycle.

Also known as: Eloxatin, NSC-266046

Arm I

Eligibility Criteria

Age18 Years - 120 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * Patients must have unresectable advanced or metastatic histologically or cytologically confirmed adenocarcinoma of the esophagus, stomach, or gastroesophageal junction (GEJ) * Patients must not have received treatment for metastatic or unresectable disease * Patients must not have brain metastases * Patients must have measurable and/or non-measurable disease * Patients who have had HER-2 expression testing prior to patient consent to this study must be HER-2 negative; if HER-2 expression has not been tested prior to patient consent to this study, a second specimen must be submitted for HER-2 expression; if the specimen is HER-2 positive (or if HER-2 could not be evaluated), the patient will not be randomized * Patients must have completed any prior neoadjuvant and adjuvant therapy for resectable disease at least 180 days prior to registration PATIENT CHARACTERISTICS: * Zubrod performance status of 0-1 * Hemoglobin ≥ 9 g/dL * Absolute neutrophil count (ANC) ≥ 1,500/mcL * Platelets ≥ 100,000/mcL * Total bilirubin ≤ 1.5 mg/dL regardless of whether patients have liver involvement secondary to tumor * AST and ALT both ≤ 3 times institutional upper limit of normal (IULN) unless the liver is involved with tumor, in which case both AST and ALT must be ≤ 5 times IULN * Serum creatinine \< 1.5 mg/dL within 28 days prior to registration AND/OR calculated creatinine clearance \> 60 mL/min * Patients must not have motor or sensory neuropathy \> Grade 1 using CTCAE version 4.0 * Patients must not be pregnant or nursing; women and men of reproductive potential must have agreed to use an effective contraceptive method * No other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease-free for five years PRIOR CONCURRENT THERAPY: * See Disease Characteristics * All palliative radiation therapy alone must be completed at least 14 days prior to registration * Patient must have no plans to receive concurrent chemotherapy, hormonal therapy, radiotherapy, immunotherapy, or any other type of therapy for treatment of cancer while on this protocol treatment

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

SWOG Cancer Research Networklead
National Cancer Institute (NCI)collaborator

Study Sites (508)

University of South Alabama Mitchell Cancer Institute

Mobile, Alabama, 36688, United States

Location

University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72205, United States

Location

Sutter Auburn Faith Hospital

Auburn, California, 95602, United States

Location

Alta Bates Summit Medical Center-Herrick Campus

Berkeley, California, 94704, United States

Location

Mills - Peninsula Hospitals

Burlingame, California, 94010, United States

Location

Sutter Davis Hospital

Davis, California, 95616, United States

Location

Los Angeles County-USC Medical Center

Los Angeles, California, 90033, United States

Location

University of Southern California/Norris Cancer Center

Los Angeles, California, 90033, United States

Location

Fremont - Rideout Cancer Center

Marysville, California, 95901, United States

Location

Memorial Medical Center

Modesto, California, 95355, United States

Location

Palo Alto Medical Foundation-Camino Division

Mountain View, California, 94040, United States

Location

Palo Alto Medical Foundation-Gynecologic Oncology

Mountain View, California, 94040, United States

Location

Sutter Cancer Research Consortium

Novato, California, 94945, United States

Location

University of California Medical Center At Irvine-Orange Campus

Orange, California, 92868, United States

Location

Palo Alto Medical Foundation Health Care

Palo Alto, California, 94301, United States

Location

Valley Medical Oncology Consultants

Pleasanton, California, 94588, United States

Location

Sutter Roseville Medical Center

Roseville, California, 95661, United States

Location

Sutter General Hospital

Sacramento, California, 95816, United States

Location

University of California at Davis Cancer Center

Sacramento, California, 95817, United States

Location

California Pacific Medical Center-Pacific Campus

San Francisco, California, 94118, United States

Location

Palo Alto Medical Foundation-Santa Cruz

Santa Cruz, California, 95065, United States

Location

Sutter Pacific Medical Foundation

Santa Rosa, California, 95403, United States

Location

Palo Atlo Medical Foundation-Sunnyvale

Sunnyvale, California, 94806, United States

Location

Tahoe Forest Cancer Center

Truckee, California, 96161, United States

Location

Sutter Solano Medical Center/Cancer Center

Vallejo, California, 94589, United States

Location

The Medical Center of Aurora

Aurora, Colorado, 80012, United States

Location

Boulder Community Hospital

Boulder, Colorado, 80301, United States

Location

Rocky Mountain Cancer Centers-Boulder

Boulder, Colorado, 80304, United States

Location

Penrose-Saint Francis Healthcare

Colorado Springs, Colorado, 80907, United States

Location

Rocky Mountain Cancer Centers-Penrose

Colorado Springs, Colorado, 80907, United States

Location

Porter Adventist Hospital

Denver, Colorado, 80210, United States

Location

Exempla Saint Joseph Hospital

Denver, Colorado, 80218, United States

Location

Presbyterian - Saint Lukes Medical Center - Health One

Denver, Colorado, 80218, United States

Location

Rocky Mountain Cancer Centers-Midtown

Denver, Colorado, 80218, United States

Location

Rocky Mountain Cancer Centers-Rose

Denver, Colorado, 80220, United States

Location

Rose Medical Center

Denver, Colorado, 80220, United States

Location

Colorado Cancer Research Program CCOP

Denver, Colorado, 80224-2522, United States

Location

Colorado Blood Cancer Institute

Denver, Colorado, 80907, United States

Location

Mercy Medical Center

Durango, Colorado, 81301, United States

Location

Comprehensive Cancer Care and Research Institute of Colorado LLC

Englewood, Colorado, 80113, United States

Location

Swedish Medical Center

Englewood, Colorado, 80113, United States

Location

Poudre Valley Hospital

Fort Collins, Colorado, 80524, United States

Location

Mountain Blue Cancer Care Center

Golden, Colorado, 80401, United States

Location

North Colorado Medical Center

Greeley, Colorado, 80631, United States

Location

Breast Cancer Care Consultants

Greenwood Village, Colorado, 80111, United States

Location

Rocky Mountain Cancer Centers-Lakewood

Lakewood, Colorado, 80228, United States

Location

Saint Anthony Hospital

Lakewood, Colorado, 80228, United States

Location

Littleton Adventist Hospital

Littleton, Colorado, 80122, United States

Location

Rocky Mountain Cancer Centers-Sky Ridge

Lone Tree, Colorado, 80124, United States

Location

Sky Ridge Medical Center

Lone Tree, Colorado, 80124, United States

Location

Longmont United Hospital

Longmont, Colorado, 80501, United States

Location

Rocky Mountain Cancer Centers-Longmont

Longmont, Colorado, 80501, United States

Location

McKee Medical Center

Loveland, Colorado, 80539, United States

Location

Parker Adventist Hospital

Parker, Colorado, 80138, United States

Location

Rocky Mountain Cancer Centers-Parker

Parker, Colorado, 80138, United States

Location

Saint Mary Corwin Medical Center

Pueblo, Colorado, 81004, United States

Location

Rocky Mountain Cancer Centers - Pueblo

Pueblo, Colorado, 81008, United States

Location

Exempla Lutheran Medical Center

Wheat Ridge, Colorado, 80033, United States

Location

Saint Francis Hospital and Medical Center

Hartford, Connecticut, 06105, United States

Location

Beebe Medical Center

Lewes, Delaware, 19958, United States

Location

Christiana Gynecologic Oncology LLC