Molecularly Tailored Therapy for Patients With Metastatic Cancer of the Esophagus and Stomach

NCT02358863 | Terminated Results DMC

• 1 other identifier: 2013-0973
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine whether molecular profile-directed therapy (otherwise known as personalized treatment) can improve the effectiveness of standard chemotherapy combinations for patients with esophagogastric adenocarcinoma. A series of tests will be performed on a sample of tumor; based on the results of these tests, a patient will be assigned to a chemotherapy treatment.

Conditions

Esophageal Cancer; Gastric Cancer

Outcome Measures

Primary Outcomes (1)

• The Number of Patients With Tumor Size Reduction (Objective Response Rate)

  Objective response rate is the sum of partial responses plus complete responses and will be assessed per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions.

  1 year

Study Arms (1)

Chemotherapy

EXPERIMENTAL

Standard chemotherapy doublet based on molecular testing using one of the following interventions: Modified FOLFOX6 Docetaxel/Capecitabine Cisplatin/Irinotecan Cisplatin/Docetaxel IRI/EPI EPI/Docetaxel Irinotecan/Docetaxel Docetaxel

Drug: Modified FOLFOX6; Drug: Docetaxel/Capecitabine; Drug: Cisplatin/Irinotecan; Drug: Cisplatin/Docetaxel; Drug: IRI/EPI; Drug: EPI/Docetaxel; Drug: Irinotecan/Docetaxel; Drug: Docetaxel

Interventions

Modified FOLFOX6 DRUG

Oxaliplatin 85 mg/m2 IV Day 1 every 14 days Leucovorin 400 mg/m2 IV over 2 hours Day 1 5-FU 400 mg/m2 IV over 2 hours Day 1 5-FU 2400 mg/m2 IV over 46 hours Day 1

Also known as: Oxaliplatin, Eloxatin, Leucovorin, 5-FU, 5-Flourouracil

Chemotherapy

Docetaxel/Capecitabine DRUG

Docetaxel 30 mg/m2 IV Days 1 and 8 Capecitabine 825 mg/m2 PO BID Days 1-14

Also known as: Taxotere, Xeloda

Chemotherapy

Cisplatin/Irinotecan DRUG

Cisplatin 30 mg/m2 IV Days 1 and 8 every 21 days Irinotecan 65 mg/m2 IV days 1 and 8 every 21 days

Also known as: Platinum, CPT-11, Camptosar

Chemotherapy

Cisplatin/Docetaxel DRUG

Cisplatin 75 mg/m2 IV Day 1 every 21 days Docetaxel 75 mg/m2 IV Day 1

Also known as: Platinum, Taxotere

Chemotherapy

IRI/EPI DRUG

Irinotecan IV over 90 minutes Days 1 and 8 every 28 days Epirubicin IV over 10-15 minutes Days 1 and 8 every 28 days

Also known as: Irinotecan, CPT-11, Epirubicin, Camptosar

Chemotherapy

EPI/Docetaxel DRUG

Docetaxel 75 mg/m2 Day 1 every 21 days Epirubicin 50 mg/m2 IV Day 2

Also known as: Taxotere, Epirubicin

Chemotherapy

Irinotecan/Docetaxel DRUG

Irinotecan 120 mg/m2 Day 1 every 21 days Docetaxel 50 mg/m2 IV Day 1

Also known as: CPT-11, Camptosar, Taxotere

Chemotherapy

Docetaxel DRUG

Docetaxel 60-100 mg/m2 IV day 1 every 21 days

Also known as: Taxotere

Chemotherapy

Eligibility Criteria

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

You may qualify if:

• Advanced, measurable metastatic esophagogastric adenocarcinoma by RECIST criteria
• Patients who have had surgery or radiotherapy with or without neoadjuvant or adjuvant chemotherapy (the wash-out period will be at least 1 month)
• Patients who are not eligible for resection and are chemotherapy naïve
• Patients with HER2(-) status
• Patients who have tumor deposit(s) that are easily accessible by ultrasound or CT guidance
• Patients must have adequate organ function
• Patients must provide written informed consent

You may not qualify if:

• Active concurrent malignancy, other than superficial, non-squamous cell carcinoma of the skin or uterine cervix, within the past three years
• ECOG performance status worse than 2
• Prior oral or intravenous chemotherapy for metastatic disease
• Patients with comorbidities that prevent them from being able to receive the chemotherapy regimen
• cardiac ejection fraction 45% or greater

Sponsors & Collaborators

• Georgetown University: lead

Study Sites (1)

Georgetown University

Washington D.C., District of Columbia, 20057, United States

Location

MeSH Terms

Conditions

Esophageal Neoplasms; Stomach Neoplasms

Interventions

Oxaliplatin; Leucovorin; Fluorouracil; Docetaxel; Capecitabine; Cisplatin; Irinotecan; Platinum; Epirubicin

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases; Stomach Diseases

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Formyltetrahydrofolates; Tetrahydrofolates; Folic Acid; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Coenzymes; Enzymes and Coenzymes; Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Diterpenes; Terpenes; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Camptothecin; Alkaloids; Metals, Heavy; Elements; Transition Elements; Metals; Doxorubicin; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates

Results Point of Contact

• Title: John Marshall, MD
• Organization: Lombardi Comprehensive Cancer Center (LCCC)

marshalj@georgetown.edu

202-444-7064

Study Officials

• John Marshall, MD

  Georgetown University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 4, 2015
• First Posted: February 9, 2015
• Study Start: February 1, 2015
• Primary Completion: November 1, 2016
• Study Completion: November 1, 2016
• Last Updated: September 6, 2018
• Results First Posted: June 4, 2018

Record last verified: 2017-08

Locations

US (1)