Preoperative Therapy With Oxaliplatin/Docetaxel/Capecitabine and Radiation in Resectable Esophagus Cancer
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Purpose
In this phase I/II trial, we will evaluate a novel combination of chemotherapy, used concurrently with radiation therapy, in the preoperative therapy of locoregional carcinoma of the esophagus and gastroesophageal junction. In the brief phase I portion of this trial, we will determine whether 2 drugs (docetaxel/oxaliplatin) or 3 drugs (docetaxel/oxaliplatin/capecitabine) can be used concurrently with radiation therapy. If the 3-drug regimen is tolerated, the phase II portion will proceed with this regimen. If the 3-drug combination is considered too toxic, the phase II study will proceed with docetaxel/oxaliplatin in combination with radiation therapy.
| Condition | Intervention | Phase |
|---|---|---|
|
Esophagus Cancer |
Drug: Oxaliplatin Drug: Docetaxel Drug: Capecitabine Radiation: Radiation therapy |
Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: 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 |
- 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 ] [ Designated as safety issue: No ]The absence of any residual tumor cells in a histologic evaluation of a tumor specimen is defined as a complete pathologic response
- Disease-Free Survival (DFS) [ Time Frame: 18 months ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]Length of time, in months, that patients were alive from their first date of protocol treatment until death.
| Enrollment: | 59 |
| Study Start Date: | April 2004 |
| Study Completion Date: | January 2009 |
| Primary Completion Date: | February 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Cohort 1
An initial cohort of 10 patients was treated with 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
|
|
Experimental: Cohort 2
After completion of the first phase of the trial, the second cohort began treatment. 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
|
Detailed Description:
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
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| 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.
Contacts and Locations| 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 | Sarah Cannon Research Institute |
More Information
Additional Information:
Publications:
| Responsible Party: | Sarah Cannon Research Institute |
| ClinicalTrials.gov Identifier: | NCT00193128 History of Changes |
| Other Study ID Numbers: | SCRI GI 57 |
| Study First Received: | September 12, 2005 |
| Results First Received: | March 26, 2013 |
| Last Updated: | March 26, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Sarah Cannon Research Institute:
|
Esophagus Cancer |
Additional relevant MeSH terms:
|
Esophageal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Head and Neck Neoplasms Digestive System Diseases Esophageal Diseases Gastrointestinal Diseases Oxaliplatin Docetaxel |
Capecitabine Fluorouracil Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on May 23, 2013