Preoperative Therapy With Oxaliplatin/Docetaxel/Capecitabine and Radiation in Resectable Esophagus Cancer
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| ClinicalTrials.gov Identifier: NCT00193128 |
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Recruitment Status :
Completed
First Posted : September 19, 2005
Results First Posted : May 13, 2013
Last Update Posted : November 24, 2021
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Esophagus Cancer | Drug: Oxaliplatin Drug: Docetaxel Drug: Capecitabine Radiation: Radiation therapy | Phase 1 Phase 2 |
Upon determination of eligibility, patients will be receive:
Oxaliplatin + Docetaxel + Capecitabine + Radiation therapy
If the three-drug chemotherapy regimen, with radiation therapy, is tolerable, this regimen will be taken forward into the phase II portion of the trial. If the three-drug regimen is too toxic, the phase II portion will proceed with the two-drug regimen Oxaliplatin + Docetaxel + Radiation therapy
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 59 participants |
| Allocation: | Non-Randomized |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | A Phase I/II Trial of Preoperative Oxaliplatin, Docetaxel, and Capecitabine With Concurrent Radiation Therapy in Localized Carcinoma of the Esophagus or Gastroesophageal Junction |
| Study Start Date : | April 2004 |
| Actual Primary Completion Date : | February 2008 |
| Actual Study Completion Date : | January 2009 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Cohort 1
Oxaliplatin 40 mg/m2 intravenously (IV) over 2 hours and docetaxel 20 mg/m2 IV over 30 minutes on days 1, 8, 15, 22, and 29. Radiation therapy began concurrently with day 1 of chemotherapy at a dose of 1.8 Gy/d Monday through Friday to a total of 45 Gy (25 fractions). Patients were to have esophageal resection after completion of preoperative therapy during weeks 9 to 12 and after all treatment-related side effects were resolved. |
Drug: Oxaliplatin
40 mg/m2 IV over 2 hours on days 1, 8, 15, 22, and 29 in both treatment cohorts
Other Name: Eloxatin Drug: Docetaxel 20 mg/m2 IV over 30 minutes was administered on days 1, 8, 15, 22, and 29 in both cohorts
Other Name: Taxotere Radiation: Radiation therapy In both cohorts, radiation therapy began concurrently with day 1 of chemotherapy at a dose of 1.8 Gy/d Monday through Friday to a total of 45 Gy (25 fractions).
Other Name: RT |
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Experimental: Cohort 2
Oxaliplatin 40 mg/m2 intravenously (IV) over 2 hours and docetaxel 20 mg/m2 IV over 30 minutes on days 1, 8, 15, 22, and 29. Capecitabine was administered 1000 mg/m2 orally twice daily on days 1 to 7, 15 to 21, and 29 to 35. Radiation therapy began concurrently with day 1 of chemotherapy at a dose of 1.8 Gy/d Monday through Friday to a total of 45 Gy (25 fractions). Patients were to have esophageal resection after completion of preoperative therapy during weeks 9 to 12 and after all treatment-related side effects were resolved. |
Drug: Oxaliplatin
40 mg/m2 IV over 2 hours on days 1, 8, 15, 22, and 29 in both treatment cohorts
Other Name: Eloxatin Drug: Docetaxel 20 mg/m2 IV over 30 minutes was administered on days 1, 8, 15, 22, and 29 in both cohorts
Other Name: Taxotere Drug: Capecitabine In Cohort 2, capecitabine was administered 1000 mg/m2 orally twice daily on days 1 to 7, 15 to 21, and 29 to 35.
Other Name: Xeloda Radiation: Radiation therapy In both cohorts, radiation therapy began concurrently with day 1 of chemotherapy at a dose of 1.8 Gy/d Monday through Friday to a total of 45 Gy (25 fractions).
Other Name: RT |
- Pathologic Complete Response Rate (PCRR), the Percentage of Patients Who Have No Evidence of Cancer in Their Surgical Specimen Following Surgery [ Time Frame: 18 months ]The absence of any residual tumor cells in a histologic evaluation of a tumor specimen following surgery is defined as a complete pathologic response
- Disease-Free Survival (DFS) [ Time Frame: 18 months ]Defined as the interval between the start date of treatment and the date of occurrence of progressive disease or death from any cause.
- Overall Survival (OS) [ Time Frame: 36 months ]Length of time, in months, that patients were alive from their first date of protocol treatment until death.
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
To be included in this study, you must meet the following criteria:
- Adenocarcinoma or squamous cell carcinoma of the esophagus or G/E junction.
- Must be surgical candidates
- No previous treatment for esophageal cancer
- Must have measurable or evaluable disease
- Able to perform activities of daily living with minimal to no assistance
- Adequate bone marrow, liver and kidney function
- Provide written informed consent
Exclusion Criteria:
You cannot participate in this study if any of the following apply to you:
- Tumor location in the proximal esophagus
- Metastatic disease or locally advanced cancer
- Moderate to severe peripheral neuropathy
- Serious pre-existing medical illnesses
- Significant heart disease
- Treated for an invasive cancer within the previous 5 years
- Women who are pregnant or breast-feeding
- Age < 18 years
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.
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): NCT00193128
| United States, California | |
| Tower Oncology | |
| Beverly Hills, California, United States, 90211 | |
| United States, Florida | |
| Integrated Community Oncology Network | |
| Jacksonville, Florida, United States, 32256 | |
| United States, Georgia | |
| Atlanta Cancer Care | |
| Atlanta, Georgia, United States, 30342 | |
| Northeast Georgia Medical Center | |
| Gainesville, Georgia, United States, 30501 | |
| Wellstar Cancer Research | |
| Marietta, Georgia, United States, 30060 | |
| United States, Kentucky | |
| Consultants in Blood Disorders and Cancer | |
| Louisville, Kentucky, United States, 40207 | |
| United States, Tennessee | |
| Tennessee Oncology | |
| Nashville, Tennessee, United States, 37203 | |
| Principal Investigator: | David R. Spigel, MD | SCRI Development Innovations, LLC |
Publications of Results:
| Responsible Party: | SCRI Development Innovations, LLC |
| ClinicalTrials.gov Identifier: | NCT00193128 |
| Other Study ID Numbers: |
SCRI GI 57 |
| First Posted: | September 19, 2005 Key Record Dates |
| Results First Posted: | May 13, 2013 |
| Last Update Posted: | November 24, 2021 |
| Last Verified: | October 2021 |
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Esophagus Cancer |
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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 Docetaxel |
Capecitabine Oxaliplatin Antineoplastic Agents Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action Antimetabolites, Antineoplastic Antimetabolites |