Paclitaxel, Cisplatin, and Radiation Therapy With or Without Cetuximab in Treating Patients With Locally Advanced Esophageal Cancer

Completed · Phase 3

Conditions studied: Esophageal Cancer

In brief

RATIONALE: Drugs used in chemotherapy, such as paclitaxel and cisplatin, 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. 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. Cetuximab may stop the growth of esophageal cancer by blocking blood flow to the tumor. It is not yet known whether giving paclitaxel and cisplatin together with radiation therapy is more effective with or without cetuximab in treating esophageal cancer. PURPOSE: This randomized phase III trial is comparing how well giving paclitaxel and cisplatin together with radiation therapy works with or without cetuximab in treating patients with locally advanced esophageal cancer.

Key facts

Study ID

NCT00655876

Run by

Radiation Therapy Oncology Group

People needed

344

Starts

2008-06-01

Expected to finish

2022-05-20

Last updated by the study team

2022-06-14

Who can join

Age: 18 and older, up to 74. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Pathologically (histologic or cytologic) proven diagnosis of primary squamous cell or adenocarcinoma of the esophagus or gastroesophageal junction within 12 weeks prior to registration. Patients with involvement of the gastroesophageal junction with Siewert type I or II tumors (tumors arising from the distal esophagus and involving the esophagogastric junction or tumors starting at the esophagogastric junction and involving the cardia) are eligible.
• 1.1 Disease must be encompassed in a radiotherapy field.
• 1.2 Patients with celiac, perigastric, mediastinal or supraclavicular adenopathy are eligible.
• 1.3 Patients with cervical esophageal carcinoma are eligible.
• Stage T1N1M0; T2-4, Any N, M0; Any T, Any N, M1a, based upon the following minimum diagnostic work-up:
• 2.1 History/physical examination within 6 weeks prior to registration
• 2.2 Positron emission tomography (PET)/positron emission tomography-computed tomography (PET-CT) scan (strongly recommended) or chest/abdominal CT within 6 weeks prior to registration
• 2.3 Electrocardiogram (EKG) within 6 weeks of study entry
• 2.4 Endoscopy with biopsy or cytology by fine needle aspiration (FNA) (must be able to document histologic subtype) within 12 weeks of study entry. Patients with T3-4 proximal thoracic esophageal tumors (15-25 cm) must undergo bronchoscopy to exclude fistula. (NOTE: Any images from endoscopic procedures up to the time of progression must be kept in the patient's confidential study file.)
• Zubrod performance status 0-2
• Age ≥ 18 and ≤ 74 (upper limit was set at 74 in an amendment)
• Complete blood count (CBC)/differential obtained within 2 weeks prior to registration on study, with adequate bone marrow function defined as follows:
• 5.1 Absolute neutrophil count (ANC) ≥ 1,500 cells/mm3
• 5.2 Platelets ≥ 100,000 cells/mm3
• 5.3 Hemoglobin ≥ 8.0 g/dl (Note: The use of transfusion or other intervention to achieve Hgb ≥8.0 g/dl is acceptable.)
• Additional laboratory studies obtained within 2 weeks prior to registration on study
• 6.1 Creatinine ≤ 1.5 mg/dl
• 6.2 Bilirubin ≤ 1.5 x upper limit of normal
• 6.3 Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≤ 3 x upper limit of normal
• 6.4 Serum pregnancy test for women of childbearing potential
• Patient's total intake (oral/enteral) must be ≥ 1500 kCal/day
• Patient must provide study-specific informed consent prior to study entry
• Women of childbearing potential and male participants must practice adequate contraception

You may not qualify if…

• Evidence of tracheoesophageal fistula, or invasion into the trachea or major bronchi. Patients with T3-4 proximal thoracic esophageal tumors (15-25 cm) must undergo bronchoscopy to exclude fistula.
• Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 2 years (For example, carcinoma in situ of the breast, oral cavity, or cervix are all permissible).
• Prior systemic chemotherapy for esophageal cancer; note that prior chemotherapy for a different cancer is allowable.
• Prior radiation therapy that would result in overlap of planned radiation therapy fields.
• Prior therapy that specifically and directly targets the epidermal growth factor receptor (EGFR) pathway.
• Prior platinum-based and/or paclitaxel-based therapy.
• Prior allergic reaction to the study drugs involved in this protocol.
• Prior severe infusion reaction to a monoclonal antibody.
• Severe, active comorbidity, defined as follows:
• 9.1 Unstable angina and/or congestive heart failure requiring hospitalization within the last 3 months
• 9.2 Transmural myocardial infarction within the last 6 months
• 9.3 Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration
• 9.4 Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of registration
• 9.5 Acquired immune deficiency syndrome (AIDS) based upon current Centers for Disease Control and Prevention (CDC) definition; note, however, that human immunodeficiency virus (HIV) testing is not required for entry into this protocol. The need to exclude patients with AIDS from this protocol is necessary because the treatments involved in this protocol may be significantly immunosuppressive. Protocol-specific requirements may also exclude immunocompromised patients.
• Pregnancy or women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception; this exclusion is necessary because the treatment involved in this study may be significantly teratogenic.
• Women who are nursing.

Where it is running

• Auburn Radiation Oncology — Auburn, California, United States
• Radiation Oncology Centers - Cameron Park — Cameron Park, California, United States
• Mercy Cancer Center at Mercy San Juan Medical Center — Carmichael, California, United States
• Enloe Cancer Center at Enloe Medical Center — Chico, California, United States
• California Cancer Center - Woodward Park Office — Fresno, California, United States
• Saint Agnes Cancer Center at Saint Agnes Medical Center — Fresno, California, United States
• Memorial Medical Center — Modesto, California, United States
• Radiation Oncology Center - Roseville — Roseville, California, United States
• Radiological Associates of Sacramento Medical Group, Incorporated — Sacramento, California, United States
• University of California Davis Cancer Center — Sacramento, California, United States
• Mercy General Hospital — Sacramento, California, United States
• Solano Radiation Oncology Center — Vacaville, California, United States
• Sutter Solano Medical Center — Vallejo, California, United States
• Rocky Mountain Cancer Centers - Aurora — Aurora, Colorado, United States
• Porter Adventist Hospital — Denver, Colorado, United States
• George Bray Cancer Center at the Hospital of Central Connecticut - New Britain Campus — New Britain, Connecticut, United States
• William W. Backus Hospital — Norwich, Connecticut, United States
• CCOP - Christiana Care Health Services — Newark, Delaware, United States
• University of Florida Shands Cancer Center — Gainesville, Florida, United States
• Ella Milbank Foshay Cancer Center at Jupiter Medical Center — Jupiter, Florida, United States
• Center for Cancer Care and Research at Watson Clinic, LLP — Lakeland, Florida, United States
• Baptist-South Miami Regional Cancer Program — Miami, Florida, United States
• CCOP - Mount Sinai Medical Center — Miami Beach, Florida, United States
• M.D. Anderson Cancer Center at Orlando — Orlando, Florida, United States
• Arizona Oncology - Tucson — Tucson, Arizona, United States

Full record on ClinicalTrials.gov

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