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

NCT01129310 | Completed Phase 2 DMC

• 1 other identifier: IXOGoo1 25412
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Gastrointestinal Neoplasm; Gastric Adenocarcinoma

Keywords

irinotecan; capecitabine; oxaliplatin; health-related quality of life; gastroesophageal(GE) junction adenocarcinoma

Outcome Measures

Primary Outcomes (1)

• Overall Response Rate and dose limiting toxicity

  2 years

Secondary Outcomes (1)

• Progression Free Survival, overall survival, death, alterations in quality of life outcomes

  2 years

Interventions

Irinotecan-Capecitabine-Oxaliplatin DRUG

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

Also known as: Camptosar; Xeloda; Eloxatin

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• AHS Cancer Control Alberta: lead
• Sanofi: collaborator

Study Sites (1)

Cross Cancer Institute

Edmonton, Alberta, T6G 1Z2, Canada

Location

MeSH Terms

Conditions

Gastrointestinal Neoplasms

Interventions

Irinotecan; Capecitabine; Oxaliplatin

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases

Intervention Hierarchy (Ancestors)

Camptothecin; Alkaloids; Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Coordination Complexes; Organic Chemicals

Study Officials

• Jennifer Spratlin, MD

  Alberta Health services

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 21, 2010
• First Posted: May 24, 2010
• Study Start: July 1, 2010
• Primary Completion: May 18, 2018
• Study Completion: May 18, 2018
• Last Updated: February 25, 2019

Record last verified: 2016-01

Locations

CA (1)