Study of Panitumumab Given First With Capecitabine and Oxaliplatin (CAPOX) and Then With Capecita… (NCT00346099) | Clinical Trial Compass
WithdrawnPhase 2
Study of Panitumumab Given First With Capecitabine and Oxaliplatin (CAPOX) and Then With Capecitabine and Radiation of the Pelvis for Treatment of Patients With Rectal Cancers That May or May Not Have Spread Beyond the Rectum
Stopped: Protocol closed based on new (and as yet unpublished) information from a phase II clinical trial.
0Started 2006-06
Plain-language summary
Panitumumab is a monoclonal antibody. It works by attaching to a protein called epidermal growth factor receptor found on normal and cancer cells. When panitumumab attaches, it blocks another protein called epidermal growth factor (EGF) from attaching to the cell. This is important because, when EGF is blocked, a cell's growth slows down or stops. Panitumumab may also help radiation therapy work. Also because panitumumab is a fully-human antibody, it may be less toxic than other monoclonal antibodies made to block the EGF receptor. Chemotherapy, such as capecitabine and oxaliplatin, works to kill cancer cells directly. Capecitabine given during radiation helps radiation therapy work better. This study is being done to learn how rectal cancer tumors that are not removed surgically respond to treatment with panitumumab and chemotherapy given before radiation therapy begins followed by treatment with panitumumab and capecitabine given with radiation therapy.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Pathologic diagnosis of rectal cancer (adenocarcinoma)
* Must have rectal cancer that is:
* locally advanced and considered not to be curable by surgery
* recurrent (if it was treated before by surgical removal of the tumor)
* present along with small-volume metastasis
* Evidence of adequate organ function (such as liver, kidneys, etc.)
* Must be able to swallow tablets
* Able to perform an adequate level of physical activity
Exclusion Criteria:
* Diagnosis of rectal cancer other than adenocarcinoma
* Patients who are candidates for surgical removal of metastatic and/or locally advanced disease
* Patients who have received previous treatments for the current cancer
* Chronic liver disease or recurrent viral hepatitis
* Any previous pelvic radiation therapy and/or any previous chemotherapy with oxaliplatin or epidermal growth factor receptor inhibitors
* Central nervous system metastases
* Active inflammatory bowel disease
* Current clinically significant abnormal peripheral nerve disease
* Active heart disease, including blocked blood vessels, recent heart attack, history of congestive heart failure, or abnormal heart beat
* Pregnancy or breast feeding
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Percentage of patients with clinical complete response rate in tumor in the pelvis at 4 to 6 weeks after completion of radiation therapy