Oxaliplatin and Irinotecan in Recurrent or Metastatic Esophageal and Gastroesophageal (GE) Junction Carcinoma

NCT00256269 | Terminated Phase 2 DMC FDA Drug

• 2 other identifiers: UCI 04-092004-3849
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

Brief Summary

The combination of cisplatin and irinotecan has significant anti-tumor activity in esophageal cancer. Oxaliplatin has been shown to have activity in combination with 5-Fluorouracil (5FU) and radiation in treatment of locally advanced esophageal cancer. Oxaliplatin also has better side effects profile than cisplatin and may be able to overcome tumors that have developed cisplatin resistance. The standard treatment of locally advanced esophageal cancer has been cisplatin, 5FU and radiation followed by possible esophagectomy. However, a large portion of these patients will relapse and the tumor may develop resistance to cisplatin and/or the cumulative toxicity from previous treatment forbids the use of cisplatin again. Weekly combination of oxaliplatin and irinotecan has been shown to be active and well tolerated in elderly population with refractory colorectal cancer. Therefore, we propose this phase II trial of a weekly oxaliplatin and irinotecan to test the effectiveness and the tolerability of this regimen in metastatic and/or recurrent esophageal cancer.

Conditions

Esophageal Cancer; Gastroesophageal Cancer

Keywords

Esophageal Cancer; Gastroesophageal junction cancer; Oxaliplatin; Irinotecan

Outcome Measures

Primary Outcomes (1)

• To assess the overall response rate

  To assess the overall response rate (complete and partial response) to a weekly combination of oxaliplatin and irinotecan in patients with unresectable or metastatic esophageal cancer or cancer of the gastro-esophageal (GE) junction.

  5 years

Secondary Outcomes (3)

• Number of participants with treatment-related adverse events as assessed by CTCAE v3.0

  5 years

• Progression Free Survival

  5 years

• Evaluation of Time to Death

  5 years

Study Arms (1)

Oxaliplatin plus Irinotecan

EXPERIMENTAL

Drug: Oxaliplatin-40 mg/m2 IV over 60 minutes Every 21 days. Drug: Irinotecan-60 mg/m2 IV over 60 minutes, immediately following oxaliplatin Every 21 days.

Drug: Oxaliplatin; Drug: Irinotecan

Interventions

Oxaliplatin DRUG

40 mg/m2 IV over 60 minutes Every 21 days

Oxaliplatin plus Irinotecan

Irinotecan DRUG

60 mg/m2 IV over 60 minutes, immediately following oxaliplatin Every 21 days

Oxaliplatin plus Irinotecan

Eligibility Criteria

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

You may qualify if:

• All patients must have histologically or cytologically confirmed diagnosis of squamous cell carcinoma or adenocarcinoma of the esophagus. Patients with tumors of the gastroesophageal junction were eligible if at least 50% of the tumor involved the esophagus.
• Patients must have locally advanced (i.e. unresectable) or metastatic disease
• All sites of disease must be assessed and designated as measurable or non-measurable disease as documented by CT, MRI, X-ray physical Each of the criteria in the following section must be met in order for a patient to be eligible for registration.
• Patients may have received prior radiotherapy if there has been complete recovery from all radiation-induced toxicities. At least 4 weeks must have been elapsed from the completion of radiation therapy to the time of registration. If lesions within the radiation port are to be used to assess response to therapy, those lesions must have demonstrated clear progression by the criteria outlined in Section 10.2d following completion of radiation therapy.
• Patients must have adequate bone marrow reserve as documented by absolute neutrophil count (ANC) \> 1,500 microliters and platelets \> 100,000/microliter obtained within 14 days prior to registration.
• Patients must have adequate hepatic as documented by serum bilirubin \< 1.5 x the institutional upper limit of normal. Serum transaminase (SGOT or SGPT) must be \< 1.5 x the institutional upper limit of normal serum unless the liver is involved with tumor, in which case serum transaminase (SGOT or SGPT) must be \< 5 x the institutional limit of normal. These tests must be obtained within 14 days prior to registration.
• Patients must have a creatinine \< 1.5 x the institutional upper limit of normal or a creatinine clearance of \> 30 cc/min calculated using the following formula obtained within 28 days prior to registration.
• Calculated Creatinine Clearance = (140-age) X wt (kg) X (0.85 if female) 72 X creatinine (mg/dl)
• These tests must have been performed within 28 days prior to registration.
• All patients must be 18 years of age or older
• Patients must have a Zubrod performance of 0-2

You may not qualify if:

• Patients must not have received prior chemotherapy for chemotherapy for advanced or metastatic esophageal cancer. Chemotherapy given adjuvantly or as a radiosensitizer is allowed if more than 8 weeks have elapsed since the treatment was completed and they have recovered from any treatment related toxicity.
• Patients must not have a surgical procedure for esophageal cancer within 4 weeks prior to registration. Patients must have completely recovered from all surgery prior to registration.
• Patients with any evidence of active or uncontrolled infection, recent myocardial infection, unstable angina, or life-threatening arrhythmia are not eligible.
• Patients with severe psychiatric disorder are not eligible.
• Patients with known brain metastasis are not eligible. However, brain-imaging studies are not required for eligibility if the patient has no neurological signs or symptoms. If brain-imaging studies are performed, they must be negative for disease.
• No other prior malignancy is allowed except for adequately treated basal cell or squamous cell carcinoma, in situ cervical cancer, or adequately treated Stage I and II cancer from which the patient is in complete remission, or any other malignancy from which the patient has been disease-free for 5 years.
• Patients should not have active infection.
• Patients should not have psychological, familial, sociological, or geographical conditions that do not permit medical follow-up and compliance with study protocol.
• Except for cancer-related abnormalities, patients should not have unstable or pre-existing major medical conditions.
• Patients should not have any immediate life-threatening complications of their malignancies.

Sponsors & Collaborators

• University of California, Irvine: lead
• Sanofi: collaborator

Study Sites (1)

Chao Family Comprehensive Cancer Center

Orange, California, 92868, United States

Location

MeSH Terms

Conditions

Esophageal Neoplasms

Interventions

Oxaliplatin; Irinotecan

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Camptothecin; Alkaloids; Heterocyclic Compounds

Study Officials

• Sai-Hong Ignatius Ou, MD

  Chao Family Comprehensive Cancer Center

  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: HS Associate Clinical Professor

Study Record Dates

• First Submitted: November 17, 2005
• First Posted: November 21, 2005
• Study Start: June 1, 2005
• Primary Completion: February 7, 2007
• Study Completion: February 7, 2007
• Last Updated: January 26, 2018

Record last verified: 2018-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)