Oxaliplatin, Capecitabine, and Radiation Therapy in Treating Patients With Locally Advanced Cancer of the Rectum
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|ClinicalTrials.gov Identifier: NCT00086931|
Recruitment Status : Completed
First Posted : July 12, 2004
Last Update Posted : March 8, 2013
RATIONALE: Drugs used in chemotherapy, such as oxaliplatin and capecitabine, work in different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Oxaliplatin and capecitabine may make tumor cells more sensitive to radiation therapy and may kill more tumor cells. Giving chemotherapy with radiation therapy before surgery may shrink the tumor so that it can be removed.
PURPOSE: This phase I/II trial is studying the side effects and best dose of oxaliplatin and capecitabine when given together with radiation therapy and to see how well they work in treating patients who are undergoing surgery for locally advanced cancer of the rectum. NOTE: *The phase I portion of this trial closed 06/2005. The best dose of oxaliplatin and capecitabine has been determined.
|Condition or disease||Intervention/treatment||Phase|
|Colorectal Cancer||Drug: capecitabine Drug: oxaliplatin Procedure: conventional surgery Procedure: neoadjuvant therapy Radiation: radiation therapy||Phase 1 Phase 2|
- Determine the maximum tolerated dose of neoadjuvant oxaliplatin and capecitabine when combined with radiotherapy in patients with locally advanced adenocarcinoma of the rectum. (Phase I closed to accrual as of 06/2005.)
- Determine the rate of complete pathological response in patients treated with this regimen.
- Determine the overall survival of patients treated with this regimen.
- Determine the rate of local and overall failure in patients treated with this regimen.
- Determine the utility of TS, TP, DPD, ERCC-1, and apoptosis to predict response in patients treated with this regimen.
- Determine the rate of pathologic down-staging in patients treated with this regimen.
- Determine the safety and toxicity of this regimen in these patients.
- Determine the rate of sphincter-saving rectal surgery in patients treated with this regimen who had been deemed candidates for abdominoperineal resection at diagnosis.
OUTLINE: This is a multicenter, phase I (phase I closed to accrual as of 06/2005), dose-escalation study of oxaliplatin and capecitabine followed by a phase II study.
- Phase I (closed to accrual as of 06/2005): Patients undergo radiotherapy once daily 5 days a week for 5.5 weeks and receive oral capecitabine twice daily on days radiotherapy is administered. Beginning on day 1 of radiotherapy, patients also receive oxaliplatin IV over 2 hours on days 1, 8, 15, 22, and 29.
Cohorts of 3-6 patients receive escalating doses of oxaliplatin and capecitabine until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.
- Phase II: Patients undergo radiotherapy and receive capecitabine and oxaliplatin as in phase I at the MTD.
All patients undergo curative-intent surgery 6-8 weeks after the completion of chemoradiotherapy.
Patients are followed every 3 months for 3 years and then every 6 months for 2 years.
PROJECTED ACCRUAL: A total of 31-40 patients (6-15 for phase I [phase I closed to accrual as of 06/2005] and 25 for phase II) will be accrued for this study within 2 years.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||37 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase I/II Study of Weekly Intravenous Oxaliplatin in Combination With Oral Daily Capecitabine and Radiation Therapy in the Neoadjuvant Treatment of Rectal Cancer|
|Study Start Date :||September 2003|
|Actual Primary Completion Date :||May 2007|
|Actual Study Completion Date :||May 2010|
- Drug: capecitabine
oral dose escalating, twice daily.
- Drug: oxaliplatin
IV over 2 hours on days 1, 8, 15, 22, and 29.
- Procedure: conventional surgery
curative-intent surgery 6-8 weeks after the completion of chemoradiotherapy
- Procedure: neoadjuvant therapy
chemotherapy and radiation prior to surgery
- Radiation: radiation therapy
once daily 5 days a week for 5.5 weeks
- Complete pathological response rate at time of surgery [ Time Frame: Time of surgery ]
- Disease-free survival, safety, and overall survival at 5 years [ Time Frame: Continuous ]
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): NCT00086931
|United States, New York|
|Roswell Park Cancer Institute|
|Buffalo, New York, United States, 14263-0001|
|Study Chair:||Marwan Fakih, MD||Roswell Park Cancer Institute|