Cisplatin, Irinotecan, and Radiation Therapy in Treating Patients With Esophageal Cancer or Gastroesophageal Junction Cancer That Can Be Removed By Surgery
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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 |
- Pathologic complete response rate after surgery [ Designated as safety issue: No ]
- 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) |
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 |
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| 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 | |
| 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 Diseases Esophageal Neoplasms Gastrointestinal Diseases Digestive System Diseases Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Head and Neck Neoplasms 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 May 23, 2013