First Line Study of Irinotecan, Capecitabine and Oxaliplatin in Metastatic Gastric or Gastroesophageal Cancer.

Gastric Adenocarcinoma Clinical Trial

— IXOGoo1  

Official title:

A Multicentre, Open-label Phase II Study of Irinotecan, Capecitabine(Xeloda), and Oxaliplatin (IXO) as First Line Treatment in Patients With Metastatic Gastric or Gastroesophageal (GEJ) Adenocarcinoma.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01129310
• Other study ID #: IXOGoo1 25412
• Status: Completed
• Phase: Phase 2
• Start date: July 2010
• Est. completion date: May 18, 2018

Study information

• Verified date: January 2016
• Source: AHS Cancer Control Alberta
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The investigators hypothesize IXO chemotherapy will have an improvement in response rate and acceptable toxicity for uncurable metastatic gastric cancer compared to historical controls.

Description:

This is a single arm, open-label, multicentre, phase II trial in which patients with metastatic gastric or GEJ adenocarcinoma will be treated with the combination of irinotecan, capecitabine, and oxaliplatin (IXO).Patients will receive the combination of irinotecan, capecitabine, and oxaliplatin at the recommended phase II dose and sequence determined by the completed phase I trial. Patients will be treated on study until disease progression, overwhelming toxicity, or consent withdrawal.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 47
• Est. completion date: May 18, 2018
• Est. primary completion date: May 18, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• histologically documented gastric GEJ adenocarcinoma not previously treated with palliative systemic therapy.

• Metastatic disease based on the presence of clinically and/or radiologically documented measurable disease based on RECIST.

• ECOG performance status of 0,1 or 2.

• Age = 18 years

• Life expectancy of least 3 months based on discretion of treating oncologist.

• Adequate hematologic, hepatic, and renal function.

• Patients who have received prior chemotherapy or radiation delivered as part of initial curative therapy (i.e. neoadjuvant or adjuvant chemotherapy administered alone and/or concurrently delivered with radiation and/or surgery) are permitted as long as that treatment was completed at least 6 months prior to study start date.

• Patients may have received prior palliative radiotherapy (unless radiation was curative therapy to pelvis or to =25% of bone marrow stores) if this radiation was = 4 weeks before study entry and patients must have recovered from the toxic effects of this treatment.

• Patients may have received prior surgery if this surgery was = 4 weeks before study entry and patients must have recovered from the toxic effects of this treatment.

• Patients must have the ability to read, understand, and sign an informed consent and must be willing to comply with study treatment and follow-up.

Exclusion Criteria:

• Patients who have received palliative chemotherapy for their metastatic gastric or GEJ tumor.

• Prior treatment with > 6 cycles of traditional alkylating agent-based chemotherapy, > 2 cycles of carboplatin-based chemotherapy, prior treatment with irinotecan or oxaliplatin chemotherapy, or concurrent treatment with other experimental drugs or anti-cancer therapy.

• Curative radiation treatment to the pelvis or radiation therapy to = 25% of bone marrow stores.

• Lack of physical integrity of the upper gastrointestinal tract, malabsorption syndrome, short gut syndrome, or history of bowel obstruction due to peritoneal metastases.

• Previous of concurrent malignancies, excluding curatively treated in situ carcinoma of the cervix or non-melanoma skin cancer, unless at least 5 years have elapsed since last treatment and the patient is considered cured.

• Any serious medical condition within 6 months prior to study entry such as myocardial infarction, uncontrolled congestive heart failure,unstable angina, active cardiomyopathy, unstable ventricular arrhythmia, cerebrovascular diseases, uncontrolled hypertension, uncontrolled diabetes, uncontrolled psychiatric disorder, serious infection, active peptic ulcer disease, or other medical condition that .....

• Gilbert's disease

• Known dihydropyrimidine dehydrogenase (DPD) deficiency.

• Pre-existing neuropathy = grade 2 from any cause.

• Patients with unstable metastasis to the central nervous system are excluded. Patients who have treated brain metastasis and are off steroids, anticonvulsants, and have documented stability of lesions for at least 3 months may be eligible. A CT scan or MRI is NOT required to rule out brain metastases unless there is clinical suspicion of CNS involvement.

• Pregnant of lactating women

Related Conditions & MeSH terms

• Adenocarcinoma
• Digestive System Neoplasms
• Gastric Adenocarcinoma
• Gastrointestinal Neoplasm
• Gastrointestinal Neoplasms

Intervention

Drug:
• Irinotecan-Capecitabine-Oxaliplatin
Irinotecan-160mg/m2 IV infusion over 60-90 min on Day 1 Capecitabine-1900mg/m2 daily PO in divided doses (=950mg/m2 BID) on days 2-15 Oxaliplatin- 100mg/m2 IV infusion over 2 hours Day 1

Locations

Country	Name	City	State
Canada	Cross Cancer Institute	Edmonton	Alberta

Sponsors (2)

Lead Sponsor	Collaborator
AHS Cancer Control Alberta	Sanofi

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Response Rate and dose limiting toxicity		2 years
Secondary	Progression Free Survival, overall survival, death, alterations in quality of life outcomes		2 years