Comparison of Efficacy and Frequency of Adverse Events of 1st Line Palliative Chemotherapy EOX and mDCF Regimens in Advanced HER2-negative Gastric Carcinoma

NCT02445209 | Completed Phase 3

• 1 other identifier: JagiellonianU-01
• Study Type: interventional
• Target: 56
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of the study is to compare efficacy and safety of palliative chemotherapy EOX and mDCF regimens in the first-line treatment of patients with advanced HER2-negative gastric and gastroesophageal junction (GEJ) adenocarcinoma

Conditions

HER2 Negative Gastric Cancer

Keywords

HER2-negative gastric and GEJ adenocarcinoma; first-line palliative chemotherapy; EOX; mDCF; efficacy; safety

Outcome Measures

Primary Outcomes (1)

• Overall Survival

  time from randomization until death from any cause

  3 years

Secondary Outcomes (2)

• Progression-free Survival

  3 years

• Safety as assessed by adverse events according to CTCAE v4.0

  3 years

Study Arms (2)

EOX

ACTIVE COMPARATOR

Epirubicin 50mg/m2 IV on day 1; Oxaliplatin 130mg/m2 IV on day 1; Capecitabine 625mg/m2/day PO BID days 1-21; Cycled every 21 days. Cycled every 3 weeks for a maximum of 8 cycles initially (24 weeks of treatment). Patients who experienced a long term response to the initial 8 cycles of EOX chemotherapy, could be rechallenged with the same regimen.

Other: EOX

mDCF

ACTIVE COMPARATOR

Docetaxel 40 mg/m2 IV od day 1; Leucovorin 400 mg/m2 IV on day 1; 5fluorouracyl 400 mg/m2 IV on day 1; 5fluorouracil 1000 mg/m2/d IV continuous infusion days 1-2; Cisplatin 40 mg/m2 IV on day 3; Cycled every 2 weeks for a maximum of 12 cycles initially (24 weeks of treatment). Patients who experienced a long term response to the initial 12 cycles of mDCF chemotherapy, could be rechallenged with the same regimen

Other: mDCF

Interventions

EOX OTHER

combined chemotherapy regimen: epirubicin + oxaliplatin + capecitabine

EOX

mDCF OTHER

combined chemotherapy regimen: docetaxel + leucovorin + 5fluorouracil + cisplatin

mDCF

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients ≥ 18 years
• histologically confirmed inoperable locally advanced, recurrent, or metastatic adenocarcinoma of the stomach or gastro-oesophageal junction;
• ECOG (Eastern Cooperative Oncology Group) performance status 0-2;
• adequate renal, hepatic, and hematologic function;
• measurable or nonmeasurable disease according to the Response Evaluation Criteria in Solid Tumors (RECIST). Patients with intraoperatively confirmed intraperitoneal metastases but without detectable disease in radiological studies were also eligible

You may not qualify if:

• HER2- positive tumors defined as either IHC 3+ or IHC 2+, the latter in combination with FISH+
• previous chemotherapy for metastatic or locally advanced disease
• surgery \<3 weeks before the onset of the study treatment
• congestive heart failure
• significant dysphagia that would preclude oral administration of capecitabine
• concurrent malignant disease, except for adequately treated tumors with high likelihood of being cured (e.g. basal cell carcinoma of the skin, cervical cancer)
• clinical evidence of brain metastases

Sponsors & Collaborators

• Jagiellonian University: lead

Related Publications (3)

• Cunningham D, Starling N, Rao S, Iveson T, Nicolson M, Coxon F, Middleton G, Daniel F, Oates J, Norman AR; Upper Gastrointestinal Clinical Studies Group of the National Cancer Research Institute of the United Kingdom. Capecitabine and oxaliplatin for advanced esophagogastric cancer. N Engl J Med. 2008 Jan 3;358(1):36-46. doi: 10.1056/NEJMoa073149.

  PMID: 18172173 BACKGROUND

• Shah MA, Stoller R, Shibata S, et al. Random assignment multicenter phase II study of modified docetaxel, cisplatin, fluorouracil (mDCF) versus DCF with growth factor support (GCSF) in metastatic gastroesophageal adenocarcinoma (GE). 2010 Gastrointestinal Cancers Symposium.

  BACKGROUND

• Ochenduszko S, Puskulluoglu M, Konopka K, Fijorek K, Urbanczyk K, Budzynski A, Matlok M, Lazar A, Sinczak-Kuta A, Pedziwiatr M, Krzemieniecki K. Comparison of efficacy and safety of first-line palliative chemotherapy with EOX and mDCF regimens in patients with locally advanced inoperable or metastatic HER2-negative gastric or gastroesophageal junction adenocarcinoma: a randomized phase 3 trial. Med Oncol. 2015 Oct;32(10):242. doi: 10.1007/s12032-015-0687-7. Epub 2015 Sep 9.

  PMID: 26354521 DERIVED

Study Officials

• Sebastian Ochenduszko, M.D., PhD

  Jagiellonian University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Sebastian Ochenduszko, MD PhD

Study Record Dates

• First Submitted: April 30, 2015
• First Posted: May 15, 2015
• Study Start: September 1, 2010
• Primary Completion: February 1, 2014
• Study Completion: February 1, 2014
• Last Updated: May 15, 2015

Record last verified: 2015-05