Esophageal Cancer Clinical Trial
Paclitaxel, Cisplatin, and Radiation Therapy With or Without Cetuximab in Treating Patients With Locally Advanced Esophageal Cancer
Summary
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.
Full Description
OBJECTIVES:
Primary
To evaluate whether the addition of cetuximab to chemotherapy comprising paclitaxel, cisplatin, and radiotherapy improves overall survival compared with paclitaxel, cisplatin, and radiotherapy alone in patients with esophageal cancer treated without surgery.
Secondary
To evaluate whether the addition of cetuximab to paclitaxel, cisplatin, and radiotherapy improves local control by increasing the clinical complete response and decreasing local recurrence in these patients.
To evaluate adverse events in these patients.
To evaluate endoscopic complete response rates in these patients.
To evaluate if the addition of cetuximab to paclitaxel, cisplatin, and radiotherapy improves the Esophageal Cancer Subscale (ECS) score of the Functional Assessment of Cancer Therapy - Esophagus (FACT-E) quality of life tool.
To evaluate the quality-adjusted survival of each treatment arm using EQ-5D if the primary endpoint supports the primary hypothesis.
OUTLINE: This is a multicenter study. Patients are stratified according to histology (adenocarcinoma vs squamous), cancer lesion size (< 5 cm vs ≥ 5 cm), and disease status of celiac nodes (present vs absent). Patients are randomized to 1 of 2 treatment arms.
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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.
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There are 172 Locations for this study
Tucson Arizona, 85704, United States
Auburn California, 95603, United States
Cameron Park California, 95682, United States
Carmichael California, 95608, United States
Chico California, 95926, United States
Fresno California, 93720, United States
Fresno California, 93720, United States
Modesto California, 95355, United States
Roseville California, 95661, United States
Sacramento California, 95815, United States
Sacramento California, 95817, United States
Sacramento California, 95819, United States
Vacaville California, 95687, United States
Vallejo California, 94589, United States
Aurora Colorado, 80012, United States
Denver Colorado, 80210, United States
New Britain Connecticut, 06050, United States
Norwich Connecticut, 06360, United States
Newark Delaware, 19713, United States
Gainesville Florida, 32610, United States
Jupiter Florida, 33458, United States
Lakeland Florida, 33805, United States
Miami Beach Florida, 33140, United States
Miami Florida, 33176, United States
Orlando Florida, 32806, United States
Columbus Georgia, 31904, United States
Savannah Georgia, 31405, United States
Honolulu Hawaii, 96813, United States
Honolulu Hawaii, 96813, United States
Honolulu Hawaii, 96817, United States
Boise Idaho, 83706, United States
Chicago Illinois, 60611, United States
Chicago Illinois, 60637, United States
Maywood Illinois, 60153, United States
Park Ridge Illinois, 60068, United States
Rockford Illinois, 61104, United States
Springfield Illinois, 62702, United States
Anderson Indiana, 46016, United States
Bloomington Indiana, 47403, United States
Fort Wayne Indiana, 46804, United States
Fort Wayne Indiana, 46805, United States
Indianapolis Indiana, 46202, United States
Indianapolis Indiana, 46219, United States
Muncie Indiana, 47303, United States
South Bend Indiana, 46601, United States
Ames Iowa, 50010, United States
Des Moines Iowa, 50309, United States
Des Moines Iowa, 50314, United States
Mason City Iowa, 50401, United States
Sioux City Iowa, 51101, United States
Louisville Kentucky, 40202, United States
Baton Rouge Louisiana, 70809, United States
Baltimore Maryland, 21201, United States
Baltimore Maryland, 21204, United States
Baltimore Maryland, 21229, United States
Fall River Massachusetts, 02721, United States
Ann Arbor Michigan, 48106, United States
Detroit Michigan, 48202, United States
Flint Michigan, 48503, United States
Grand Rapids Michigan, 49503, United States
Grosse Pointe Woods Michigan, 48236, United States
Kalamazoo Michigan, 49007, United States
Livonia Michigan, 48154, United States
Port Huron Michigan, 48060, United States
Saginaw Michigan, 48601, United States
Bemidji Minnesota, 56601, United States
Coon Rapids Minnesota, 55433, United States
Maplewood Minnesota, 55109, United States
Saint Paul Minnesota, 55101, United States
Saint Paul Minnesota, 55102, United States
Jackson Mississippi, 39216, United States
Cape Girardeau Missouri, 63703, United States
Saint Louis Missouri, 63110, United States
Saint Louis Missouri, 63131, United States
Saint Louis Missouri, 63141, United States
Billings Montana, 59107, United States
Great Falls Montana, 59405, United States
Omaha Nebraska, 68114, United States
Omaha Nebraska, 68130, United States
Las Vegas Nevada, 89106, United States
Concord New Hampshire, 03301, United States
Dover New Hampshire, 03820, United States
Exeter New Hampshire, 03833, United States
Keene New Hampshire, 03431, United States
Lebanon New Hampshire, 03756, United States
Manchester New Hampshire, 03103, United States
Long Branch New Jersey, 07740, United States
Marlton New Jersey, 08053, United States
Sparta New Jersey, 07871, United States
Toms River New Jersey, 08755, United States
Voorhees New Jersey, 08043, United States
Albany New York, 12206, United States
Binghamton New York, 13905, United States
Glens Falls New York, 12801, United States
New York New York, 10003, United States
New York New York, 10025, United States
New York New York, 10065, United States
Sleepy Hollow New York, 10591, United States
Asheville North Carolina, 28801, United States
Burlington North Carolina, 27216, United States
Charlotte North Carolina, 28233, United States
Kinston North Carolina, 28501, United States
Fargo North Dakota, 58122, United States
Akron Ohio, 44307, United States
Akron Ohio, 44309, United States
Barberton Ohio, 44203, United States
Canton Ohio, 44708, United States
Canton Ohio, 44710, United States
Cleveland Ohio, 44106, United States
Cleveland Ohio, 44109, United States
Mentor Ohio, 44060, United States
Middleburg Heights Ohio, 44130, United States
Orange Village Ohio, 44122, United States
Ravenna Ohio, 44266, United States
Westlake Ohio, 44145, United States
Oklahoma City Oklahoma, 73104, United States
Tulsa Oklahoma, 74136, United States
Clackamas Oregon, 97015, United States
Eugene Oregon, 97401, United States
Portland Oregon, 97213, United States
Portland Oregon, 97225, United States
Beaver Pennsylvania, 15009, United States
Clairton Pennsylvania, 15025, United States
Drexel Hill Pennsylvania, 19026, United States
Erie Pennsylvania, 16505, United States
Gettysburg Pennsylvania, 17325, United States
Greensburg Pennsylvania, 15601, United States
Philadelphia Pennsylvania, 19114, United States
Philadelphia Pennsylvania, 19141, United States
Pittsburgh Pennsylvania, 15213, United States
Pittsburgh Pennsylvania, 15215, United States
Pittsburgh Pennsylvania, 15237, United States
Reading Pennsylvania, 19612, United States
Seneca Pennsylvania, 16346, United States
York Pennsylvania, 17405, United States
Providence Rhode Island, 02903, United States
Providence Rhode Island, 02904, United States
Charleston South Carolina, 29425, United States
Greenville South Carolina, 29605, United States
Greenville South Carolina, 29615, United States
Seneca South Carolina, 29672, United States
Spartanburg South Carolina, 29303, United States
Spartanburg South Carolina, 29303, United States
Spartanburg South Carolina, 29307, United States
Rapid City South Dakota, 57701, United States
Sioux Falls South Dakota, 57117, United States
Knoxville Tennessee, 37916, United States
Amarillo Texas, 79106, United States
Bedford Texas, 76022, United States
Denton Texas, 76210, United States
Fort Worth Texas, 76104, United States
Houston Texas, 77024, United States
Longview Texas, 75601, United States
Lubbock Texas, 79410, United States
San Antonio Texas, 78217, United States
Sherman Texas, 75090, United States
Sugar Land Texas, 77479, United States
Tyler Texas, 75702, United States
Wichita Falls Texas, 76310, United States
Murray Utah, 84157, United States
Saint George Utah, 84770, United States
Salt Lake City Utah, 84106, United States
Salt Lake City Utah, 84112, United States
Vancouver Washington, 98684, United States
Wheeling West Virginia, 26003, United States
Green Bay Wisconsin, 54303, United States
Green Bay Wisconsin, 54307, United States
Marinette Wisconsin, 54143, United States
Milwaukee Wisconsin, 53295, United States
Oconomowoc Wisconsin, 53066, United States
Sturgeon Bay Wisconsin, 54235, United States
Waukesha Wisconsin, 53188, United States
Wausau Wisconsin, 54401, United States
Saint John New Brunswick, E2L 4, Canada
Montreal Quebec, H2W 1, Canada
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