Trial Search Results
Paclitaxel, Cisplatin, and Radiation Therapy With or Without Cetuximab in Treating Patients With Locally Advanced Esophageal Cancer
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.
Stanford is currently not accepting patients for this trial.
Radiation Therapy Oncology Group
Collaborator: National Cancer Institute (NCI)
- Drug: cetuximab
- Drug: cisplatin
- Drug: paclitaxel
- Radiation: radiation therapy
1. 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
- 1.3 Patients with cervical esophageal carcinoma are eligible.
2. Stage T1N1M0; T2-4, Any N, M0; Any T, Any N, M1a, based upon the following minimum
- 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
3. Zubrod performance status 0-2
4. Age ≥ 18 and ≤ 74 (upper limit was set at 74 in an amendment)
5. 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.)
6. 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
7. Patient's total intake (oral/enteral) must be ≥ 1500 kCal/day
8. Patient must provide study-specific informed consent prior to study entry
9. Women of childbearing potential and male participants must practice adequate
1. 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.
2. 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).
3. Prior systemic chemotherapy for esophageal cancer; note that prior chemotherapy for a
different cancer is allowable.
4. Prior radiation therapy that would result in overlap of planned radiation therapy
5. Prior therapy that specifically and directly targets the epidermal growth factor
receptor (EGFR) pathway.
6. Prior platinum-based and/or paclitaxel-based therapy.
7. Prior allergic reaction to the study drugs involved in this protocol.
8. Prior severe infusion reaction to a monoclonal antibody.
9. 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
- 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
10. 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
11. Women who are nursing.
Ages Eligible for Study
18 Years - 74 Years
Genders Eligible for Study