Status:
COMPLETED
Irinotecan, Cisplatin, Bevacizumab, Radiation Therapy, and Surgery in Treating Patients With Locally Advanced Esophageal Cancer
Lead Sponsor:
Memorial Sloan Kettering Cancer Center
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Esophageal Cancer
Eligibility:
All Genders
18-120 years
Phase:
PHASE2
Brief Summary
RATIONALE: Drugs used in chemotherapy, such as irinotecan and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monocl...
Detailed Description
OBJECTIVES: Primary * Evaluate the toxicity and safety of bevacizumab when given together with cisplatin, irinotecan hydrochloride, and radiotherapy followed by surgery and adjuvant bevacizumab in p...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically confirmed adenocarcinoma of the esophagus or gastroesophageal junction
- T1, N1, M0 or T2-4, any N, M0 esophageal carcinoma that is surgically resectable
- Disease must be clinically limited to the esophagus or gastroesophageal junction
- If tumor extends below the gastroesophageal junction into the proximal stomach, 50% of the tumor must involve the distal esophagus or gastroesophageal junction
- No carcinoma in situ (Tis) or tumors determined to be T1, N0 after endoscopy, endoscopic ultrasound, or CT scan
- No gastric cancers with minor involvement of the gastroesophageal junction or distal esophagus
- No metastatic disease, including any of the following:
- M1a celiac or supraclavicular disease
- Positive malignant cytology of the pleura, pericardium, or peritoneum
- Radiographic evidence of distant organ involvement, including lung, liver, bone, or brain
- No involvement of nonregional lymph nodes including supraclavicular or celiac lymph node metastases that cannot be contained within a radiation field
- No biopsy-proven tumor invasion of the tracheobronchial tree or presence of tracheoesophageal fistula
- No recurrent laryngeal nerve or phrenic nerve paralysis
- No CNS or brain metastases
- PATIENT CHARACTERISTICS:
- ECOG performance status 0-1
- WBC ≥ 3,000/mm³
- Absolute neutrophil count ≥ 1,500/mm³
- Platelet count ≥ 100,000/mm³
- Hemoglobin ≥ 9.0 g/dL
- INR ≤ 1.5 (except for patients requiring full-dose warfarin while on bevacizumab)
- Creatinine ≤ 1.5 mg/dL
- Bilirubin ≤ 1.5 mg/dL
- AST and ALT \< 2.5 times normal
- Urine protein ≤ 1+ by urinalysis OR \< 1 g of protein by 24-hour urine collection
- Calcium \< 12 mg/dL
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No other prior malignancy (except for basal cell or squamous cell carcinoma of the skin, in situ cervical carcinoma, or superficial transitional cell bladder carcinoma) diagnosed and/or treated within the past 3 years
- No known Gilbert's disease
- No clinically significant hearing loss
- No known hypersensitivity to bevacizumab or other study drugs
- No severe comorbid conditions, including any of the following:
- Severe uncontrolled diabetes
- Prior stroke or cerebrovascular disease
- Uncontrolled infection
- Nonmalignant illness that precludes study treatment
- No history of serious systemic disease, including any of the following:
- Myocardial infarction within the past 6 months
- Uncontrolled hypertension (i.e., blood pressure \> 160/110 mm Hg on medication)
- Unstable angina
- New York Heart Association class II-IV congestive heart failure
- Unstable symptomatic arrhythmia requiring medication
- Chronic atrial arrhythmia (i.e., atrial fibrillation or paroxysmal supraventricular tachycardia) allowed
- Peripheral vascular disease ≥ grade 2
- No significant traumatic injury within the past 28 days
- No evidence of bleeding diathesis or coagulopathy
- No other concurrent medical or psychiatric condition or disease that would preclude study participation
- PRIOR CONCURRENT THERAPY:
- No prior radiotherapy
- Recovered from prior oncologic or other major surgery
- No major surgery or open biopsy within the past 28 days
- No fine-needle aspiration or core biopsies within the past 7 days
- At least 1 week since prior and no concurrent participation in another experimental drug study (unless Genentech sponsored)
- No other concurrent major surgery
- No other concurrent chemotherapy
- No concurrent sargramostim (GM-CSF)
- No concurrent phenytoin, carbamazepine, barbiturates, rifampin, phenobarbital, Hypericum perforatum (St. John's wort), or other antiepileptic medication
Exclusion
Key Trial Info
Start Date :
April 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2015
Estimated Enrollment :
34 Patients enrolled
Trial Details
Trial ID
NCT00354679
Start Date
April 1 2006
End Date
June 1 2015
Last Update
May 16 2016
Active Locations (1)
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1
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065