Combination Chemotherapy and Cetuximab in Treating Patients With Metastatic Esophageal Cancer or Gastroesophageal Junction Cancer

NCT00381706

Last updated date
Study Location
Norwalk Hospital
Norwalk, Connecticut, 06856, United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Esophageal Cancer
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years

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Advanced Information
Descriptive Information
Brief Title  ICMJE Combination Chemotherapy and Cetuximab in Treating Patients With Metastatic Esophageal Cancer or Gastroesophageal Junction Cancer
Official Title  ICMJE Randomized Phase II Study of ECF-C, IC-C, or FOLFOX-C in Metastatic Esophageal and GE Junction Cancer
Brief Summary

RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Giving more than one chemotherapy drug (combination chemotherapy) together with cetuximab may kill more tumor cells.

PURPOSE: This randomized phase II trial is studying three different combination chemotherapy regimens to compare how well they work when given together with cetuximab in treating patients with metastatic esophageal cancer or gastroesophageal junction cancer.

Detailed Description

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to histology (squamous cell carcinoma vs adenocarcinoma) and Eastern Cooperative Oncology Group (ECOG) performance status (0 or 1 vs 2). Patients are randomized to 1 of 3 treatment arms. For more information please see the "Arms" section which includes a detailed description of the treatment regimens.

The primary objective of the study is evaluate the tumor response rate (RR) for each of the regimens in this trial and to select the most promising regimen based on RR for further testing in patients with metastatic esophageal or GE junction adenocarcinoma. The secondary objectives are:

  1. To evaluate overall survival (OS) for each of the regimens in this trial in patients with metastatic esophageal or GE junction adenocarcinoma.
  2. To evaluate progression-free survival (PFS) for each of the regimens in this trial in patients with metastatic esophageal or GE junction adenocarcinoma.
  3. To evaluate time to treatment failure (TTF) for each of the regimens in this trial in patients with metastatic esophageal or GE junction adenocarcinoma.
  4. To determine the type and severity of toxicities associated with each of these regimens in the multi-institutional phase II setting.
  5. Quantitative immunohistochemistry results will be correlated with objective response rate, overall survival and time to progression.
  6. To evaluate the cellular damage (apoptosis) as a result of oxaliplatin.
  7. To determine if germline EGFR variants correlate with skin rash in patients treated with cetuximab.
  8. To evaluate if a correlation exists between germline EGFR variants and tumor EFGR expression as measured by immunohistochemistry.

All subjects must be premedicated with diphenhydramine hydrochloride 50 mg IV (or a similar agent) prior to the first dose of cetuximab in an effort to minimize infusion and hypersensitivity reactions. Premedication is recommended prior to subsequent doses, but the dose of diphenhydramine (or similar agent) may be reduced at the investigator's discretion. More information is detailed in the protocol including a description of the premedication requirements. Patients were closely monitored for treatment-related adverse events. After completion of study treatment, patients are followed periodically for up to 2 years.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Esophageal Cancer
Intervention  ICMJE
  • Biological: cetuximab
    given IV
    Other Name: C225
  • Drug: ECF
    epirubicin and 5-fluorouracil given IV
    Other Name: Ellence (epirubicin) and 5-fluorouracil (5-FU)
  • Drug: IC
    cisplatin and irinotecan given IV
    Other Name: Platinol-AQ (cisplatin), CPT-11 (irinotecan)
  • Drug: FOLFOX
    oxaliplatin , leucovorin and 5-fluorouracil IV
    Other Name: Eloxatin (oxaliplatin), folinic acid (leucovorin), and 5-fluorouracil (5-FU)
Study Arms  ICMJE
  • Experimental: Arm A (ECF + cetuximab)
    Patients receive cetuximab 400 mg/m^2 IV over 120 minutes on day 1 of the first cycle, then 250 mg/m^2 IV over 60 minutes thereafter. Patients receive cetuximab IV on days 1, 8 and 15. Patients receive epirubicin 50 mg/m^2 IV after cetuximab on day 1 followed by cisplatin 60 mg/m^2 IV over 60 minutes. On days 1-21, patients receive 5-fluorouracil 200 mg/m^2/day continuous IV infusion. Treatment repeats every 21 days in the absence of disease progression and unacceptable toxicity.
    Interventions:
    • Biological: cetuximab
    • Drug: ECF
  • Experimental: Arm B (IC + cetuximab)
    Patients receive cetuximab 400 mg/m^2 IV over 120 minutes on day 1 of the first cycle, then 250 mg/m^2 IV over 60 minutes thereafter. Patients receive cetuximab on days 1, 8 and 15. Patients receive cisplatin 30 mg/m^2 IV over 30 minutes on days 1 and 8 after cetuximab. Patients also receive irinotecan 65 mg/m^2 IV over 90 minutes on days 1 and 8 after receiving cisplatin.Treatment repeats every 21 days in the absence of disease progression and unacceptable toxicity.
    Interventions:
    • Biological: cetuximab
    • Drug: IC
  • Experimental: ARM C (FOLFOX + cetuximab)
    Patients receive cetuximab 400 mg/m^2 IV over 120 minutes on day 1 of the first cycle, then 250 mg/m^2 IV over 60 minutes thereafter. Patients receive cetuximab on days 1 and 8. On Day 1, patients also receive oxaliplatin 85 mg/m^2 IV over 120 minutes and leucovorin 400 mg/m^2 IV over 120 minutes either concurrently with oxaliplatin via a separate infusion line or post oxaliplatin administration. Following leucovorin, patients will receive 5-fluorouracil 400 mg/m^2 IV bolus injection, then 5-fluorouracil 2400 mg/m^2 IV infusion over 46-48 hours. Treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity.
    Interventions:
    • Biological: cetuximab
    • Drug: FOLFOX
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 15, 2014)
245
Original Enrollment  ICMJE Not Provided
Study Completion Date  ICMJE Not Provided
Actual Primary Completion Date April 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE
  1. Metastatic disease of the esophagus or gastroesophageal junction

    1. Histologic, cytologic or radiologic documentation of metastatic squamous cell carcinoma or adenocarcinoma of the esophagus or gastroesophageal junction. Radiologic, endoscopic, histologic or cytologic evidence of locally recurrent or locally residual (post-resection) disease is also permitted.
    2. For the purposes of this study, undifferentiated adenocarcinomas and adenosquamous tumors will be considered as adenocarcinomas. In addition, tumors involving the gastroesophageal junction will be defined by the Siewert classification.
    3. Patients with gastroesophageal junction tumors who are eligible:

      • AEG Type I: Adenocarcinoma of the distal esophagus which usually arises from an area with specialized intestinal metaplasia of the esophagus (eg, Barrett's esophagus, and may infiltrate the esophagogastric junction from above).
      • AEG Type II: True carcinoma of the cardia arising from the cardiac epithelium or short segments with intestinal metaplasia at the esophagogastric junction.
    4. Patients with gastroesophageal junction tumors who are NOT eligible:

      • AEG Type III: Subcardial gastric carcinoma which infiltrates the esophagogastric junction and distal esophagus from below.
  2. Patients must have at least one paraffin block available (or at least 15 unstained slides for analysis of tumor EGFR status.

    1. Patients with a history of esophageal and GE junction carcinoma treated by surgical resection who develop radiological or clinical evidence of metastatic cancer do not require separate histological or cytological confirmation of metastatic disease unless an interval of greater than five years has elapsed between the primary surgery and the development of metastatic disease OR the primary cancer was stage I.
    2. Clinicians should consider biopsy of lesions to establish the diagnosis of metastatic esophageal or GE junction carcinoma if there is substantial clinical ambiguity regarding the nature or source of apparent metastases.
  3. Patients with Measurable Disease - Lesions 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.
  4. Prior Treatment:

    1. No prior chemotherapy or radiotherapy. No prior therapy which specifically and directly targets the EGF(R) pathway.
    2. No prior allergic reaction to chimerized or murine monoclonal antibody therapy or documented presence of human anti-mouse antibodies (HAMA).
    3. Patients must have completed any major surgery ? 4 weeks or any minor surgery ? 2 weeks before registration. Patients must have fully recovered from the procedure. Insertion of a vascular access device is not considered major or minor surgery.
    4. No concurrent use of investigational agents is allowed while participating in this study.
  5. Patient Characteristics:

    1. ECOG Performance Status of 0-2
    2. ? 18 years of age
    3. Patients must be documented to have a stable weight (or less than one pound weight loss) for at least one week prior to registration.
    4. Non-pregnant and not breast-feeding. The effects of cetuximab, cisplatin, epirubicin, fluorouracil, leucovorin, irinotecan, and oxaliplatin on a developing human fetus are not well-known. Because the risk of toxicity in nursing infants secondary to cetuximab, cisplatin, epirubicin, fluorouracil, irinotecan, and oxaliplatin treatment of the mother is unknown but may be harmful, breastfeeding must be discontinued.
  6. No myocardial infarction < 6 months prior to registration or New York Heart Association classification III or IV.
  7. No ? grade 2 diarrhea within 7 days prior to registration.
  8. Patients may not concurrently have any of the following conditions:

    1. Known central nervous system metastases or carcinomatous meningitis
    2. Interstitial pneumonia or symptomatic interstitial fibrosis of the lung
    3. Seizure disorder or active neurological disease requiring anti-epileptic medication
    4. ? grade 2 peripheral neuropathy
  9. No evidence of Gilbert's Syndrome - Patients with Gilbert's Syndrome may have a greater risk of irinotecan toxicity due to the abnormal glucuronidation of SN-38, the active metabolite of irinotecan. Evidence of Gilbert's Syndrome would include documentation of elevation of indirect bilirubin at any time in the patient's medical history.
  10. Required Initial Laboratory Data:

    1. Granulocytes ? 1500/µl
    2. Platelet count ? 100,000/µl
    3. Creatinine ? 1.5 mg/dL
    4. AST (SGOT) ? 5.0 x Upper limits of normal
    5. Total bilirubin ? 1.5 mg/dL
    6. Albumin ? 2.5 grams/dL
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00381706
Other Study ID Numbers  ICMJE CALGB-80403
ECOG-E1206
CDR0000505535 ( Other Identifier: Physician Data Query )
NCI-2009-00492 ( Other Identifier: NCI Clinical Trial Reporting Program )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Alliance for Clinical Trials in Oncology
Study Sponsor  ICMJE Alliance for Clinical Trials in Oncology
Collaborators  ICMJE
  • National Cancer Institute (NCI)
  • Eastern Cooperative Oncology Group
  • Bristol-Myers Squibb
  • Sanofi
  • Pfizer
Investigators  ICMJE
Study Chair:Peter Enzinger, MDDana-Farber Cancer Institute
PRS Account Alliance for Clinical Trials in Oncology
Verification Date January 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP