Phase 2
N=34
Irinotecan, Cisplatin, Bevacizumab, Radiation Therapy, and Surgery in Treating Patients With Locally Advanced Esophageal Cancer
Esophageal Cancer
Bottom Line
View on ClinicalTrials.gov: NCT00354679 ↗Enrolled (actual)
34
Serious AEs
48.5%
Results posted
Feb 2016
Primary outcome: Primary: Evaluation of Safety and Toxicity — 1; 1; 1; 1 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- bevacizumab (Biological); cisplatin (Drug); irinotecan hydrochloride (Drug); proteomic profiling (Genetic); diagnostic laboratory biomarker analysis (Other); mass spectrometry (Other); adjuvant therapy (Procedure); neoadjuvant therapy (Procedure); therapeutic conventional surgery (Procedure); radiation therapy (Radiation)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Memorial Sloan Kettering Cancer Center
- Primary completion
- Jun 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Evaluation of Safety and Toxicity |
1; 1; 1; 1; 5; 7 | — |
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. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some find tumor cells and kill them or carry tumor-killing substances to them. Others interfere with the ability of tumor cells to grow and spread. Bevacizumab may also stop the growth of esophageal cancer by blocking blood flow to the tumor. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving chemotherapy and monoclonal antibody therapy together with radiation therapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving bevacizumab after surgery may kill any tumor cells that remain after surgery.
PURPOSE: This phase II trial is studying how well giving irinotecan, cisplatin, and bevacizumab together with radiation therapy followed by surgery and bevacizumab works in treating patients with locally advanced esophageal cancer.
Eligibility Criteria
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 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
Data sourced from ClinicalTrials.gov (NCT00354679). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.