Phase II Study of Oxaliplatin, Irinotecan, and Capecitabine in Advanced Gastric/Gastroesophageal Junction Carcinoma

NCT00084617 | Completed Phase 2 Results

• 4 other identifiers: NCI-2012-03010CASE 1203CDR0000365464U01CA062502
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

Brief Summary

Drugs used in chemotherapy, such as oxaliplatin, irinotecan, and capecitabine, work in different ways to stop tumor cells from dividing so they stop growing or die. Giving more than one chemotherapy drug may kill more tumor cells. This phase II trial is studying how well giving oxaliplatin together with irinotecan and capecitabine works in treating patients with metastatic or inoperable locally advanced gastric cancer or gastroesophageal junction adenocarcinoma (cancer).

Conditions

Adenocarcinoma of the Gastroesophageal Junction; Diffuse Adenocarcinoma of the Stomach; Intestinal Adenocarcinoma of the Stomach; Mixed Adenocarcinoma of the Stomach; Recurrent Gastric Cancer; Stage IIIA Gastric Cancer; Stage IIIB Gastric Cancer; Stage IIIC Gastric Cancer; Stage IV Gastric Cancer

Outcome Measures

Primary Outcomes (1)

• Response Rates (RR) in Metastatic Gastric/GE Junction Tumors

  Response is defined as the number of patients with a CR (Complete Response) or PR (Partial Response) per Response Evaluation Criteria in Solid Tumor (RECIST criteria). Possible evaluations include: CR: Disappearance of all target lesions. PR: At least a 30% decrease in the size of target lesions. Progressive Disease (PD): At least a 20% increase in the size of the target lesions or appearance of one or more new lesions. Stable Disease (SD): Neither sufficient shrinkage or increase of target lesions.

  at 12 weeks (after 2 cycles of treatment)

Secondary Outcomes (2)

• Complete Response (CR) and Partial Response (PR) Duration

  at 40 months from study activation

• Overall Survival

  at 40 months from study activation

Study Arms (1)

Treatment (oxaliplatin, irinotecan, capecitabine)

EXPERIMENTAL

Patients receive oxaliplatin IV over 2 hours and irinotecan IV over 30 minutes on days 1, 8, 15, and 22 and oral capecitabine twice daily on days 1-5, 8-12, 15-19, and 22-26. Courses repeat every 42 days in the absence of disease progression or unacceptable toxicity.

Drug: oxaliplatin; Drug: irinotecan hydrochloride; Drug: capecitabine

Interventions

oxaliplatin DRUG

Given IV

Also known as: 1-OHP, Dacotin, Dacplat, Eloxatin, L-OHP

Treatment (oxaliplatin, irinotecan, capecitabine)

irinotecan hydrochloride DRUG

Given IV

Also known as: Campto, Camptosar, CPT-11, irinotecan, U-101440E

Treatment (oxaliplatin, irinotecan, capecitabine)

capecitabine DRUG

Given orally

Also known as: CAPE, Ro 09-1978/000, Xeloda

Treatment (oxaliplatin, irinotecan, capecitabine)

Eligibility Criteria

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

You may qualify if:

• Patients must have histologically or cytologically confirmed gastric adenocarcinoma or adenocarcinoma of the gastroesophageal junction. Patients must have metastatic or inoperable locally advanced disease; GE Junction tumor location should be documented in the patient's medical record chart using the Siewert classification below:
• Type I: Adenocarcinoma of the distal esophagus which usually arises from an area with specialized intestinal metaplasia of the esophagus and which may infiltrate the GE junction from above Type II: True carcinoma of the cardia arising from the cardiac epithelium or short segments with intestinal metaplasia at the GE junction Type III: Subcardial gastric carcinoma which infiltrates the GE junction and distal esophagus from below
• Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as \>= 20 mm with conventional techniques or as \>= 10 mm with spiral CT scan
• No prior chemotherapy for metastatic or recurrent disease is allowed; one course of neoadjuvant chemotherapy and/or adjuvant chemotherapy with or without radiation therapy as primary treatment is acceptable; at least 4 weeks must have elapsed since prior radiation therapy; patients must have been off previous anti-cancer therapy for at least 4 weeks
• Life expectancy of \>= 12 weeks
• ECOG performance status 0-2
• Hemoglobin \>= 9.5 g/dL
• Absolute neutrophil count \>= 1,500/uL
• Platelets \>= 100,000/uL
• Total bilirubin =\< 1.5 mg/dL
• Creatinine =\< 1.5 mg/dL OR creatinine clearance \>= 60 mL/min/1.73 m\^2 for patients with creatinine levels above institutional normal
• The effects of oxaliplatin, irinotecan, and capecitabine on the developing human fetus at the recommended therapeutic dose are unknown; for this reason and because these drugs are known to be teratogenic, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately
• Ability to understand and the willingness to sign a written informed consent document

You may not qualify if:

• Patients who have had chemotherapy or radiotherapy within 4 weeks prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier
• Patients may not be receiving any other investigational agents
• Patients with known brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events; patients should have no greater than grade 2 neuropathy
• History of allergic reactions attributed to compounds of similar chemical or biologic composition to oxaliplatin, irinotecan and capecitabine
• Patients with NYHA classification III or IV heart disease are ineligible
• Patients must not have a known hypersensitivity to 5-fluorouracil
• Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
• Pregnant women are excluded from this study because the study drugs have the potential to cause teratogenic or abortifacient effects; because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with the study drugs, breastfeeding should be discontinued if the mother is treated with oxaliplatin, irinotecan or capecitabine
• Patients with immune deficiency are at increased risk of lethal infections when treated with marrow-suppressive therapy; therefore, HIV-positive patients receiving combination anti-retroviral therapy are excluded from the study because of possible pharmacokinetic interactions with the study drugs; appropriate studies will be undertaken in patients receiving combination anti-retroviral therapy when indicated
• Patients who are unable to take oral medications are not eligible

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

Case Western Reserve University

Cleveland, Ohio, 44106, United States

Location

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

Oxaliplatin; Irinotecan; Capecitabine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Joanna Brell MD
• Organization: National Cancer Institute

brelljm@mail.nih.gov

240-276-7050

Study Officials

• Joanna Brell

  Case Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

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

Study Record Dates

• First Submitted: June 10, 2004
• First Posted: June 11, 2004
• Study Start: March 1, 2004
• Primary Completion: October 1, 2008
• Study Completion: December 1, 2008
• Last Updated: May 1, 2015
• Results First Posted: May 1, 2015

Record last verified: 2013-07

Locations

US (1)