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Chemotherapy, Radiation Thera...

Chemotherapy, Radiation Therapy, and Cetuximab Followed by Surgery, Docetaxel, and Cetuximab in Treating Patients With Esophageal Cancer or Gastroesophageal Junction Cancer

Last Updated: 2023-07-03

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-10-02

Study Completion Date

2014-02-28

Brief Summary

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RATIONALE: Drugs used in chemotherapy, such as oxaliplatin, fluorouracil, and docetaxel, 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. Giving these treatments before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving docetaxel and cetuximab after surgery may kill any tumor cells that remain after surgery.

PURPOSE: This phase II trial is studying how well giving chemotherapy and radiation therapy together with cetuximab followed by surgery, docetaxel and cetuximab works in treating patients with esophageal cancer or gastroesophageal junction cancer.

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Detailed Description

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OBJECTIVES:

Primary

* To determine the pathologic complete response (pCR) rate of neoadjuvant chemoradiotherapy with OX/5-FU/radiotherapy (RT) plus cetuximab in patients with resectable adenocarcinoma of the esophagus.

Secondary

* To evaluate the safety of neoadjuvant chemoradiotherapy with OX/5-FU/RT plus cetuximab in patients with resectable adenocarcinoma of the esophagus.
* To evaluate the safety and tolerability of adjuvant therapy comprising cetuximab and docetaxel in these patients.
* To carry out exploratory studies to determine if activity of this regimen correlates with epidermal growth factor receptor (EGFR)-related genetic and pathway activation markers and circulating endothelial and tumor cells.

OUTLINE: This is a multicenter study.

* Neoadjuvant chemoradiotherapy and cetuximab: Patients receive oxaliplatin intravenously (IV) over 2 hours on days 1, 15, and 29, cetuximab IV over 1-2 hours on days 1, 8, 15, 22, and 29, and 5-FU IV continuously over 24 hours on days 1-35. Patients also undergo radiotherapy once daily on days 1-5, 8-12, 15-19, 22-26, and 29-33. Patients then proceed to surgery.
* Surgery: Patients undergo surgical resection within 4-8 weeks after completion of neoadjuvant chemoradiotherapy and cetuximab. Patients with an R0 or R1 resection proceed to adjuvant therapy. Patients whose tumors have not been completely resected or who have metastatic disease discontinue protocol therapy and receive further therapy at the discretion of the treating physician.
* Adjuvant therapy: Within 4-8 weeks after surgery, patients receive docetaxel IV over 1 hour on days 1, 8, 15, 22, and 29 and cetuximab IV over 1-2 hours on days 1, 8, 15, 22, 29, and 36. Treatment repeats every 6 weeks for 2 courses in the absence of disease progression or unacceptable toxicity.

Patients are followed every 3 months for 2 years, and then every 6 months for 3-5 years.

Conditions

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Esophageal Cancer

Study Design

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Allocation Method

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Neoadjuvant therapy, Surgery, adjuvant therapy

Neoadjuvant chemoradiotherapy and cetuximab: Patients (pts) receive oxaliplatin IV over 2 hours on days 1, 15, and 29, cetuximab IV over 1-2 hours on days 1, 8, 15, 22, and 29, and 5-FU IV over 24 hours on days 1-35. Pts also undergo radiotherapy once daily on days 1-5, 8-12, 15-19, 22-26, and 29-33. Pts then proceed to surgery.

Surgery: Pts undergo surgical resection within 4-8 weeks after completion of neoadjuvant chemoradiotherapy and cetuximab. Pts with an R0 or R1 resection proceed to adjuvant therapy. Pts whose tumors have not been completely resected or who have metastatic disease discontinue protocol therapy and receive further therapy at the discretion of the treating physician.

Adjuvant therapy: Within 4-8 weeks after surgery, pts receive docetaxel IV over 1 hour on days 1, 8, 15, 22, and 29 and cetuximab IV over 1-2 hours on days 1, 8, 15, 22, 29, and 36. Treatment repeats every 6 weeks for 2 courses in the absence of disease progression or unacceptable toxicity.

Group Type EXPERIMENTAL

5-Fluorouracil

Intervention Type DRUG

given IV

Oxaliplatin

Intervention Type DRUG

given IV

Cetuximab

Intervention Type DRUG

given IV

Docetaxel

Intervention Type DRUG

given IV

Surgery

Intervention Type PROCEDURE

Patients underwent surgical resection within 4-8 weeks after completion of neoadjuvant chemoradiotherapy and cetuximab.

Radiotherapy

Intervention Type RADIATION

Patients underwent radiotherapy once daily on days 1-5, 8-12, 15-19, 22-26, and 29-33.

Interventions

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5-Fluorouracil

given IV

Intervention Type DRUG

Oxaliplatin

given IV

Intervention Type DRUG

Cetuximab

given IV

Intervention Type DRUG

Docetaxel

given IV

Intervention Type DRUG

Surgery

Patients underwent surgical resection within 4-8 weeks after completion of neoadjuvant chemoradiotherapy and cetuximab.

Intervention Type PROCEDURE

Radiotherapy

Patients underwent radiotherapy once daily on days 1-5, 8-12, 15-19, 22-26, and 29-33.

Intervention Type RADIATION

Other Intervention Names

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5-FU Fluorouracil Adrucil Efudex Trans-l-diaminocyclohexane oxalatoplatinum Cis-[oxalato (trans-I-1,2-diaminocyclohexane) platinum(II)] l-OHP Eloxatin Eloxatine Dacplat 5R96669 Erbitux C225 Taxotere RP 56976

Eligibility Criteria

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Inclusion Criteria

* Newly diagnosed adenocarcinoma of the esophagus (\> 20 cm below the incisors) or gastroesophageal (GE) junction, untreated with chemotherapy, radiation therapy, and surgery. Endoscopy with biopsy and dilation was permitted.
* Tumor stage T2N0M0, T3N0M0, T1-3N+M0, or T1-3N0-1M1A as determined by imaging studies performed no greater than 4 weeks prior to registration, and biopsy, where appropriate. Celiac nodal metastasis (M1A disease) was permitted if other eligibility criteria were met. Data from endoscopic ultrasound and endoscopy were required for staging. The following imaging was required: CT scan with IV contrast and PET or PET+CT. If the PET/CT incorporates CT with IV contrast, then a separate CT is not required. If laparoscopy or other relevant procedures were performed, the data were to be incorporated into stage assignment. Any lesion suspicious for metastasis had to have been biopsied to prove eligibility.
* Tumor extension into cardia, if present, must have been no more than 2 cm.
* Tumors must have been considered surgically resectable (T1-3, not T4).
* Eastern Cooperative Oncology Group (ECOG) performance status 0-1
* Granulocytes \> 1,000/ mm³
* Platelets \> 100,000 μL
* Creatinine normal or creatinine clearance \> 60 mL/min
* Total serum bilirubin \< 1.5 mg/dL
* Fertile patients must use effective contraception
* History of a curatively treated malignancy from which the patient has been disease-free for ≥ 2 years and has a survival prognosis of \> 5 years

Exclusion Criteria

* Pregnant or breast-feeding.
* Prior severe infusion reaction to a monoclonal antibody
* prior therapy specifically and directly targeting the epidermal growth factor receptor (EGFR) pathway
* Hypertension
* Uncontrolled diabetes
* Intercurrent illness that would likely interfere with protocol therapy or prevent surgical resection
* Any of the following within the past 6 months:

* New York Heart Association class III-IV congestive heart failure
* Cerebrovascular accident or transient ischemic attack
* Unstable angina or myocardial infarction

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Michael K. Gibson, MD

Role: STUDY_CHAIR

University of Pittsburgh

Locations

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Tunnell Cancer Center at Beebe Medical Center

Lewes, Delaware, United States

Site Status

CCOP - Christiana Care Health Services

Newark, Delaware, United States

Site Status

Rush-Copley Cancer Care Center

Aurora, Illinois, United States

Site Status

Robert H. Lurie Comprehensive Cancer Center at Northwestern University

Chicago, Illinois, United States

Site Status

Hematology and Oncology Associates

Chicago, Illinois, United States

Site Status

Decatur Memorial Hospital Cancer Care Institute

Decatur, Illinois, United States

Site Status

Hinsdale Hematology Oncology Associates

Hinsdale, Illinois, United States

Site Status

Midwest Center for Hematology/Oncology

Joliet, Illinois, United States

Site Status

Joliet Oncology-Hematology Associates, Limited - West

Joliet, Illinois, United States

Site Status

North Shore Oncology and Hematology Associates, Limited - Libertyville

Libertyville, Illinois, United States

Site Status

La Grange Oncology Associates - Geneva

Naperville, Illinois, United States

Site Status

Cancer Care and Hematology Specialists of Chicagoland - Niles

Niles, Illinois, United States

Site Status

Swedish-American Regional Cancer Center

Rockford, Illinois, United States

Site Status

Hematology Oncology Associates - Skokie

Skokie, Illinois, United States

Site Status

Regional Cancer Center at Memorial Medical Center

Springfield, Illinois, United States

Site Status

Carle Cancer Center at Carle Foundation Hospital

Urbana, Illinois, United States

Site Status

CCOP - Carle Cancer Center

Urbana, Illinois, United States

Site Status

Saint Anthony Memorial Health Centers

Michigan City, Indiana, United States

Site Status

McFarland Clinic, PC

Ames, Iowa, United States

Site Status