FOLFIRI Alternate With FOLFOX in Untreated Metastatic Gastric and Esophageal Adenocarcinoma

NCT03528876 | Terminated Phase 2

• 1 other identifier: 99183
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 2

Brief Summary

Background: Gastro-esophageal (GE) cancers are a highly aggressive disease and are one of the major causes of cancer-related death worldwide. In general, combination chemotherapy has been associated with better outcomes compared with single agent chemotherapy. Fluoropyrimidine doublets FOLFOX (infusional 5FU and oxaliplatin) or FOLFIRI (infusional 5FU and irinotecan) are some of the standard first-line regimens and are less toxic than the anthracycline containing three drug regimen. Although platinum compounds are very effective in GE cancers, patients who are treated with platinum-based therapy often develop severe neuropathy and may not be able to tolerate a salvage second-line paclitaxel-based therapy. Objectives: To evaluate progression free survival, time to progression, overall survival, toxicity and quality of life in previously untreated patients with metastatic GE cancers who will be treated with a novel biweekly regimen comprised of two cycles of FOLFOX alternating with two cycles of FOLFIRI. To determine the correlation between various clinical and pathological biomarkers including an early FDG-PET scan response and patient outcomes. Design: Phase 2 clinical trial Methods: Thirty-six adult patients with histologically proven HER2 negative metastatic adenocarcinomas or poorly differentiated GE cancers will be recruited at the two major cancer centers in Saskatchewan over a period of two years. Patients will receive chemotherapy every two weeks and will undergo periodic imaging studies every 8 weeks. A Cox proportional analysis will be performed to assess various clinical and pathologic factors including an early FDG-PET/CT response and their correlation with patient outcomes. Significance: The LOGIC study aims to develop an effective but potentially less toxic regimen in the management of metastatic GE cancers, offering the possibility of longer disease control as a result of 100% exposure to two active doublets in a first-line treatment setting with lower neurotoxicities and an improved rate of salvage second-line therapy. This study will inform the care of patients with metastatic GE cancers and will be used to design a larger phase 3 trial to establish a more effective but less toxic chemotherapy regimen for patients with metastatic GE cancer and to establish role of FDG-PET/CT scan and other biomarkers in predicting outcomes.

Conditions

Metastatic Gastro-esophageal Adenocarcinoma

Keywords

gastric cancer; esophageal cancer; adnocarcinoma; FOLFIRI; FOLFOX; Metastatic cancer

Outcome Measures

Primary Outcomes (1)

• Progression free survival

  Time from enrollment till the date of disease progression

  At 12 months

Secondary Outcomes (4)

• overall survival

  At 3 years

• Metabolic response rate

  At 2 months

• Neurotpathy

  At 6 and 12 months

• Decline in quality of life

  At 6 and 12 months

Study Arms (1)

Single arm intervention study

OTHER

Biweekly FOLFOX for two cycles alternating with FOLFIRI for two cycles (FOLFOX-FOLFIRI)

Drug: FOLFOX and FOLFIRI

Interventions

FOLFOX and FOLFIRI DRUG

a biweekly regimen comprised of two cycles of FOLFOX alternating with two cycles of FOLFIRI.

Single arm intervention study

Eligibility Criteria

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

You may qualify if:

• Adult patients (≥18 years older) with histologically proven HER2 negative adenocarcinoma or poorly differentiated carcinoma of the esophagus, GE junction tumors, and gastric cancer.
• Measurable or assessable metastatic disease.
• Performance status World Health Organization (WHO) 0-2 and life expectancy of greater than 3 months.
• No previous chemotherapy for advanced disease.
• Adequate functioning of the bone marrow, liver, and kidneys.

You may not qualify if:

• Breastfeeding or pregnancy.
• Active second primary cancer except in situ cancer or non-melanoma skin cancer.
• Cerebral metastases or leptomeningeal carcinomatosis.
• Severe or uncompensated concomitant medical conditions including peripheral neuropathy.

Sponsors & Collaborators

• University of Saskatchewan: lead

Study Sites (2)

Allan Blair Cancer Center

Regina, Saskatchewan, S4T7T1, Canada

Location

Saskatoon Cancer Center

Saskatoon, Saskatchewan, S7N4H4, Canada

Location

MeSH Terms

Conditions

Stomach Neoplasms; Esophageal Neoplasms; Neoplasm Metastasis

Interventions

Folfox protocol

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Head and Neck Neoplasms; Esophageal Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Shahid Ahmed, Md, PhD

  University of Saskatchewan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: May 1, 2018
• First Posted: May 18, 2018
• Study Start: September 1, 2018
• Primary Completion: October 29, 2020
• Study Completion: October 29, 2020
• Last Updated: November 2, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

CA (2)