Chemotherapy, Radiation Therapy and Immunotherapy Prior to Surgery in Operable Esophageal Cancer
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT00393068 |
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Recruitment Status :
Completed
First Posted : October 26, 2006
Results First Posted : November 30, 2012
Last Update Posted : March 2, 2022
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The purpose of this study is to see if adding two targeted drugs (bevacizumab and erlotinib) further improves the response to chemotherapy (5-FU, paclitaxel, carboplatin) and radiation therapy in patients with operable esophageal cancer.
Side effects (toxicity) information will also be collected.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Esophageal Cancer | Drug: Erlotinib Drug: Bevacizumab Drug: Paclitaxel Drug: Carboplatin Drug: 5-FU Procedure: Radiation therapy Procedure: Surgery | Phase 2 |
Surgical removal has been the standard treatment for operable esophageal cancer. However, recent studies have shown improved results when patients receive a short course of chemotherapy and radiation therapy prior to surgery.
Prior to surgery study treatment will be given over a 6 weeks (Days 1-42) period. Beginning Day 1 and continuing through Day 35 patients will receive a continuous infusion of 5-FU by vein. A small portable pump will be used to administer this drug into a tube that has been surgically inserted into the patient's vein. On Day 1 and 22 patients will also receive the drugs paclitaxel, carboplatin and bevacizumab by vein. Erlotinib is given by mouth beginning on Day 1 and continuing through Day 45. Patients will receive radiation therapy daily, Monday through Friday, beginning Day 1-35 (approximately 5 weeks).
Surgery will be performed approximately 12-14 weeks after beginning this combined treatment.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 62 participants |
| Allocation: | N/A |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | A Phase II Trial of Preoperative Concurrent Chemotherapy/Radiation Therapy Plus Bevacizumab/Erlotinib in the Treatment of Localized Esophageal Cancer |
| Study Start Date : | February 2007 |
| Actual Primary Completion Date : | September 2009 |
| Actual Study Completion Date : | August 2011 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Treatment
Prior to surgery study treatment will be given over a 6 weeks (Days 1-42) period. Beginning Day 1 and continuing through Day 35 patients will receive a continuous infusion of 5-FU by vein. A small portable pump will be used to administer this drug into a tube that has been surgically inserted into the patient's vein. On Day 1 and 22 patients will also receive the drugs paclitaxel, carboplatin and bevacizumab by vein. Erlotinib is given by mouth beginning on Day 1 and continuing through Day 45. Patients will receive radiation therapy daily, Monday through Friday, beginning Day 1-35 (approximately 5 weeks). Surgery will be performed approximately 12-14 weeks after beginning this combined treatment. |
Drug: Erlotinib
Erlotinib
Other Name: Tarceva Drug: Bevacizumab Bevacizumab
Other Name: Avastin Drug: Paclitaxel Paclitaxel
Other Name: Taxol Drug: Carboplatin Carboplatin
Other Name: Paraplatin Drug: 5-FU 5-FU
Other Name: Fluorouracil Procedure: Radiation therapy Radiation therapy Procedure: Surgery Surgery |
- Pathologic Complete Response (pCR) Rate [ Time Frame: 18 months ]pCR was defined as no residual viable cancer found at the primary site or regional lymph nodes upon pathologic review of the surgical specimen for patients who went to surgical resection.
- Overall Survival [ Time Frame: 32 months ]Overall Survival (OS) is defined as the time interval from the start of treatment until death. Patients who remained alive were censored at the date of their last tumor assessment.
- Progression-Free Survival [ Time Frame: 36 months ]Progression-free survival (PFS) was defined as the interval from the date of first treatment until the date of disease progression or death, whichever occurred first. Patients who did not progress were censored at the date of their last tumor assessment.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Clinically confirmed esophageal or gastroesophageal junction cancer stage I, II or III
- No prior treatment for esophageal cancer
- Must be surgical candidate based on stage and location of disease
- Measurable or evaluable disease
- Able to be up and perform self care
- Adequate liver, renal function and bone marrow function
- Patients will have to have a central venous access device placed
- Able to give written informed consent.
- Age 18 or older
Exclusion Criteria:
- Stage IV disease
- Prior cancer treatment for advanced cancer in the last 5 years
- Pregnant or lactating women
- History of stroke, transient ischemic attacks, or acute MI within the past 6 months or any other serious cardiovascular disease
- History of neurological disease
- Recent history of blood in the sputum or vomitus
- Non-healing wounds, ulcer or long bone fractures
- History of bleeding problems or coagulation problems
- History of abdominal fistula, gi perforation or intrabdominal abscess within 6 months
- History of uncontrolled hypertension
Please note: There are additional inclusion/exclusion criteria. The study center will determine if you meet all of the criteria. If you do not qualify for the trial, study personnel will explain the reasons. If you do qualify, study personnel will explain the trial in detail and answer any questions you may have. You can then decide if you wish to participate.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00393068
| United States, Florida | |
| Florida Cancer Specialists | |
| Fort Myers, Florida, United States, 33901 | |
| Integrated Community Oncology Network | |
| Jacksonville, Florida, United States, 32256 | |
| United States, Georgia | |
| Northeast Georgia Medical Center | |
| Gainesville, Georgia, United States, 30501 | |
| United States, Kentucky | |
| Consultants in Blood Disorders and Cancer | |
| Louisville, Kentucky, United States, 40207 | |
| United States, New Jersey | |
| Hematology Oncology Associates of Northern NJ | |
| Morristown, New Jersey, United States, 07960 | |
| United States, Ohio | |
| Aultman Hospital | |
| Canton, Ohio, United States, 44710 | |
| Oncology Hematology Care | |
| Cincinnati, Ohio, United States, 45242 | |
| United States, Tennessee | |
| Chattanooga Oncology Hematology Associates | |
| Chattanooga, Tennessee, United States, 37404 | |
| Tennessee Oncology, PLLC | |
| Nashville, Tennessee, United States, 37023 | |
| Principal Investigator: | John D Hainsworth, MD | SCRI Development Innovations, LLC |
| Responsible Party: | SCRI Development Innovations, LLC |
| ClinicalTrials.gov Identifier: | NCT00393068 |
| Other Study ID Numbers: |
SCRI GI 91 |
| First Posted: | October 26, 2006 Key Record Dates |
| Results First Posted: | November 30, 2012 |
| Last Update Posted: | March 2, 2022 |
| Last Verified: | February 2022 |
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Esophageal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Head and Neck Neoplasms Digestive System Diseases Esophageal Diseases Gastrointestinal Diseases Paclitaxel Bevacizumab Carboplatin Fluorouracil Erlotinib Hydrochloride Antineoplastic Agents, Phytogenic |
Antineoplastic Agents Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action Antineoplastic Agents, Immunological Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Physiological Effects of Drugs Growth Inhibitors Antimetabolites Antimetabolites, Antineoplastic Immunosuppressive Agents Immunologic Factors |