Cisplatin, Irinotecan, and Radiation Therapy in Treating Patients With Esophageal Cancer or Gastroesophageal Junction Cancer That Can Be Removed By Surgery

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2011 by National Cancer Institute (NCI).
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00316862
First received: April 19, 2006
Last updated: September 6, 2012
Last verified: August 2011
  Purpose

RATIONALE: Drugs used in chemotherapy, such as cisplatin and irinotecan, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving combination chemotherapy together with radiation therapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.

PURPOSE: This phase II trial is studying how well giving cisplatin and irinotecan together with radiation therapy works in treating patients with esophageal cancer or gastroesophageal junction cancer that can be removed by surgery.


Condition Intervention Phase
Esophageal Cancer
Drug: cisplatin
Drug: irinotecan hydrochloride
Procedure: conventional surgery
Procedure: neoadjuvant therapy
Radiation: radiation therapy
Phase 2

Study Type: Interventional
Study Design: Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Trial of Preoperative Irinotecan, Cisplatin and Radiation in Esophageal Cancer

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Pathologic complete response rate after surgery [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Toxicity [ Designated as safety issue: Yes ]
  • Disease-free survival as assessed by the Kaplan and Meier method [ Designated as safety issue: No ]
  • Overall survival as assessed by the Kaplan and Meier method [ Designated as safety issue: No ]
  • Patterns of failure [ Designated as safety issue: No ]

Estimated Enrollment: 90
Study Start Date: February 2006
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

Primary

  • Determine the pathologic complete response rate in patients with surgically resectable esophageal cancer treated with neoadjuvant induction chemotherapy comprising cisplatin and irinotecan hydrochloride (CI) followed by chemoradiotherapy comprising CI and radiotherapy.

Secondary

  • Evaluate potential response or progression of disease during induction chemotherapy with positron emission tomography (PET) scan.
  • Evaluate the toxicity and tolerability of this regimen, including surgical morbidity and mortality, in these patients.
  • Determine the overall survival, disease-free survival, and pattern of failure in patients treated with this regimen.

OUTLINE: This is a multicenter study.

  • Induction chemotherapy: Patients receive irinotecan hydrochloride IV over 30-90 minutes and cisplatin IV over 30 minutes on days 1 and 8 in courses 1 and 2. Treatment repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.
  • Chemoradiotherapy: Beginning 2 weeks after completion of induction chemotherapy, patients receive irinotecan hydrochloride and ciplatin as above on days 1 and 8 in courses 3 and 4 and undergo radiotherapy daily in course 3.Treatment repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.
  • Surgery: Approximately 4-8 weeks after completion of chemoradiotherapy, patients undergo surgery to remove the tumor.

Patients undergo fludeoxyglucose F 18 positron emission tomography (FDG-PET) imaging at baseline, 15-19 days after the start of induction chemotherapy, and within 7 days before beginning chemoradiotherapy.

After completion of study treatment, patients are followed every 3 months for 2 years and then every 6 months for 3 years.

PROJECTED ACCRUAL: A total of 90 patients will be accrued for this study.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically or cytologically confirmed carcinoma of the esophagus or gastroesophageal junction of 1 of the following subtypes:

    • Squamous cell carcinoma (closed to accrual as of 04/19/10)
    • Adenocarcinoma
    • Poorly differentiated carcinoma
    • Carcinoma not otherwise specified
  • Meets 1 of the following stage criteria:

    • T2-4, N0-1, M0 disease by endoscopic ultrasound (EUS)
    • T1 tumors allowed if they are T1, N1, M0
    • Regional thoracic lymph node involvement (N1) is allowed
    • No in situ carcinoma

      • No clinical involvement of supraclavicular or celiac lymph nodes by EUS, CT scan, or PET scan unless proven to be false positive by biopsy
  • Meets the following criteria regarding extent of disease:

    • Disease must be clinically limited to the esophagus or gastroesophageal junction*
    • If the tumor extends below the gastroesophageal junction into the proximal stomach, 50% of the tumor must involve the distal esophagus or gastroesophageal junction* NOTE: *Adenocarcinomas of the distal esophagus include tumors of the distal esophagus, or Siewert type I; tumors of the gastroesophageal junction which involve, equally, both the distal esophagus and proximal stomach or Siewert type II
  • Tumor must be surgically resectable
  • No cervical esophageal tumors
  • No gastric cancers with minor involvement of the gastroesophageal junction or distal esophagus
  • No tracheoesophageal fistulas
  • No evidence of metastatic disease, including either of the following:

    • Positive malignant cytology of the pleura, pericardium, or peritoneum
    • Radiographic evidence of distant organ involvement, including lung, liver, bone, or brain

PATIENT CHARACTERISTICS:

  • ECOG performance status 0-1
  • Absolute neutrophil count ≥ 1,500/mm^3
  • Platelet count ≥ 100,000/mm^3
  • Hemoglobin > 9 g/dL
  • Creatinine normal
  • Bilirubin ≤ 1.5 mg/dL
  • FEV_1 and pulmonary function test ≥ 1.2 liters OR ≥ 35% of normal
  • Not pregnant or nursing
  • Fertile patients must use effective contraception
  • No history of clinically significant ventricular arrhythmia requiring ongoing medication with antiarrhythmic drugs
  • No myocardial infarction within the past 6 months
  • No angina
  • No New York Heart Association class III or IV heart disease
  • No history of active seizure disorder
  • No clinically significant hearing loss
  • No known Gilbert's disease.
  • No evidence of recurrent laryngeal nerve or phrenic nerve paralysis
  • No prior malignancies except basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, superficial transitional cell bladder carcinoma, or other cancer for which the patient has been disease free for at least 3 years

PRIOR CONCURRENT THERAPY:

  • At least 4 weeks since prior major surgery
  • Recovered from the effects of minor surgery (including laparoscopy or thoracoscopy)
  • No prior chemotherapy
  • No prior radiotherapy
  • No ongoing treatment with phenytoin, phenobarbital, or other antiepileptic medication

    • Valproic acid allowed
  • No concurrent palliative radiotherapy
  • No concurrent intensity-modulated radiotherapy
  • No concurrent treatment with hormones or other chemotherapeutic agents except for the following:

    • Steroids for adrenal failure
    • Hormones for nondisease-related conditions (e.g., insulin for diabetes)
    • Dexamethasone as an antiemetic prior to cisplatin therapy
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00316862

Locations
United States, Indiana
Elkhart General Hospital
Elkhart, Indiana, United States, 46515
Howard Community Hospital
Kokomo, Indiana, United States, 46904
Center for Cancer Therapy at LaPorte Hospital and Health Services
La Porte, Indiana, United States, 46350
Saint Joseph Regional Medical Center
Mishawaka, Indiana, United States, 46545-1470
CCOP - Northern Indiana CR Consortium
South Bend, Indiana, United States, 46601
Memorial Hospital of South Bend
South Bend, Indiana, United States, 46601
Michiana Hematology-Oncology, PC - South Bend
South Bend, Indiana, United States, 46601
United States, Iowa
Holden Comprehensive Cancer Center at University of Iowa
Iowa City, Iowa, United States, 52242-1002
United States, Maine
CancerCare of Maine at Eastern Maine Medical Center
Bangor, Maine, United States, 04401
Maine Center for Cancer Medicine and Blood Disorders - Scarborough
Scarborough, Maine, United States, 04074
United States, Michigan
Lakeland Regional Cancer Care Center - St. Joseph
St. Joseph, Michigan, United States, 49085
United States, Nebraska
Methodist Estabrook Cancer Center
Omaha, Nebraska, United States, 68114
United States, New Hampshire
New Hampshire Oncology - Hematology, PA at Payson Center for Cancer Care
Concord, New Hampshire, United States, 03301
New Hampshire Oncology - Hematology, PA - Hooksett
Hooksett, New Hampshire, United States, 03106
Lakes Region General Hospital
Laconia, New Hampshire, United States, 03246
Elliot Regional Cancer Center at Elliot Hospital
Manchester, New Hampshire, United States, 03103
United States, New York
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263-0001
Veterans Affairs Medical Center - Buffalo
Buffalo, New York, United States, 14215
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10065
SUNY Upstate Medical University Hospital
Syracuse, New York, United States, 13210
United States, North Carolina
Wayne Memorial Hospital, Incorporated
Goldsboro, North Carolina, United States, 27534
United States, Ohio
Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States, 43210-1240
United States, Vermont
Mountainview Medical
Berlin, Vermont, United States, 05602
Fletcher Allen Health Care - University Health Center Campus
Burlington, Vermont, United States, 05401
Sponsors and Collaborators
Cancer and Leukemia Group B
Investigators
Study Chair: David H. Ilson, MD, PhD Memorial Sloan-Kettering Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: Monica M. Bertagnolli, Cancer and Leukemia Group B
ClinicalTrials.gov Identifier: NCT00316862     History of Changes
Other Study ID Numbers: CDR0000468495, CALGB-80302
Study First Received: April 19, 2006
Last Updated: September 6, 2012
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
adenocarcinoma of the esophagus
stage II esophageal cancer
stage III esophageal cancer

Additional relevant MeSH terms:
Esophageal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases
Irinotecan
Cisplatin
Camptothecin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Antineoplastic Agents, Phytogenic
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on April 17, 2014