Rectal CancerPhase 2NCT00346099
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
A Phase 2 study testing Panitumumab with capecitabine and oxaliplatin (CAPOX) followed by and Panitumumab with capecitabine and radiation in people with Rectal Cancer and Neoplasm Metastasis, run by NSABP Foundation Inc.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rectal Cancer, Neoplasm Metastasis
- What is being tested?
- Panitumumab with capecitabine and oxaliplatin (CAPOX) followed by and Panitumumab with capecitabine and radiation
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jun 2006to May 2007
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
About this study
Official title: A Phase II Study to Determine the Efficacy and Safety of Panitumumab in Combination With Chemoradiotherapy for Unresectable or Locally Recurrent Adenocarcinoma of the Rectum With or Without Metastatic Disease
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.
Read the detailed description
Colorectal cancers express EGF and/or EGFR mRNA in 66% of primary tumors, 44% of adjacent mucosa, and up to 62% of positive lymph nodes. Patients enrolled in NSABP FR-1 will begin therapy with the anti-EGFR antibody panitumumab--which has shown single-agent activity in colorectal cancer patients--in combination with CAPOX, an effective treatment for patients with advanced colorectal cancer, with the convenience of using an oral fluoropyrimidine (capecitabine.) The intent with this first phase is to expose distant metastases to the agents early and to shrink the tumor before giving radiation therapy. After chemotherapy, radiotherapy with capecitabine and panitumumab will be given to destroy the primary tumor. Panitumumab is added to the radiochemotherapy regimen because data showed positive results when another anti-EGFR antibody was added to radiotherapy in patients with head and neck cancer. This approach aims to improve neoadjuvant combined modality therapy for rectal cancer; it should provide effective therapy for eligible patients and valuable information about clinical tumor response rates and treatment tolerability, which, if favorable, may be used to develop future Phase III trials.
- Conditions
- Rectal Cancer, Neoplasm Metastasis
- Being tested
- Panitumumab with capecitabine and oxaliplatin (CAPOX) followed by, Panitumumab with capecitabine and radiation
- Keywords
- NSABP, panitumumab, rectal cancer, colorectal cancer, oxaliplatin, capecitabine, combined modality therapy, combined pelvic radiation therapy, Rectal cancer with or without metastasis
- Medical subject headings
- Rectal Neoplasms, Neoplasm Metastasis, Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Panitumumab with capecitabine and oxaliplatin (CAPOX) followed byDrug
Panitumumab with capecitabine and radiationDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients with clinical complete response rate in tumor in the pelvis at 4 to 6 weeks after completion of radiation therapy
Secondary outcomes (4)
Percentage of patients with pathologic complete response rate of the primary rectal tumor and resected regional lymph nodes(tissue removed at the time of surgery)
Percentage of patients whose surgical evaluation following therapy indicates candidacy for resection
Percentage of patients who have progressive disease in the pelvis from the time of study entry to 2 years
The toxicity of panitumumab in combination with chemotherapy and in combination with chemoradiotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2006 (estimated)
- Study startJun 2006
- Study completionMay 2007 (estimated)
Why it stopped: Protocol closed based on new (and as yet unpublished) information from a phase II clinical trial.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- NSABP Foundation Inc
- Sponsor type
- Research network
- Collaborators
- Amgen
- Investigators
- Norman Wolmark, MD, Principal investigator, National Surgical Adjuvant Breast and Bowel Project Foundation, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00346099
- Sponsor's protocol ID
- NSABP FR-1
- Status last verified
- Dec 2007
- First submitted
- 27 Jun 2006
- Last updated
- 7 Jan 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study to Determine the Efficacy and Safety of Panitumumab in Combination With Chemoradiotherapy for Unresectable or Locally Recurrent Adenocarcinoma of the Rectum With or Without Metastatic Disease
- ClinicalTrials.gov ID
- NCT00346099
- Acronym / sponsor ID
- NSABP FR-1
- Conditions
- Rectal Cancer, Neoplasm Metastasis
- Keywords
- NSABP, panitumumab, rectal cancer, colorectal cancer, oxaliplatin, capecitabine, combined modality therapy, combined pelvic radiation therapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Protocol closed based on new (and as yet unpublished) information from a phase II clinical trial.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- NSABP Foundation IncResearch network
- Collaborators
- Amgen
- Study start
- Jun 2006
- Study completion
- May 2007 (estimated)
- First posted
- 29 Jun 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Colorectal cancers express EGF and/or EGFR mRNA in 66% of primary tumors, 44% of adjacent mucosa, and up to 62% of positive lymph nodes. Patients enrolled in NSABP FR-1 will begin therapy with the anti-EGFR antibody panitumumab--which has shown single-agent activity in colorectal cancer patients--in combination with CAPOX, an effective treatment for patients with advanced colorectal cancer, with the convenience of using an oral fluoropyrimidine (capecitabine.) The intent with this first phase is to expose distant metastases to the agents early and to shrink the tumor before giving radiation therapy. After chemotherapy, radiotherapy with capecitabine and panitumumab will be given to destroy the primary tumor. Panitumumab is added to the radiochemotherapy regimen because data showed positive results when another anti-EGFR antibody was added to radiotherapy in patients with head and neck cancer. This approach aims to improve neoadjuvant combined modality therapy for rectal cancer; it should provide effective therapy for eligible patients and valuable information about clinical tumor response rates and treatment tolerability, which, if favorable, may be used to develop future Phase III trials.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Pathologic diagnosis of rectal cancer (adenocarcinoma)
- Must have rectal cancer that is:
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Panitumumab with capecitabine and oxaliplatin (CAPOX) followed by | Drug | – |
| Panitumumab with capecitabine and radiation | Drug | – |
Primary outcome
Percentage of patients with clinical complete response rate in tumor in the pelvis at 4 to 6 weeks after completion of radiation therapy
4 secondary outcomes
Percentage of patients with pathologic complete response rate of the primary rectal tumor and resected regional lymph nodes(tissue removed at the time of surgery)
Percentage of patients whose surgical evaluation following therapy indicates candidacy for resection
Percentage of patients who have progressive disease in the pelvis from the time of study entry to 2 years
The toxicity of panitumumab in combination with chemotherapy and in combination with chemoradiotherapy
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2008.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Norman Wolmark, MD principal investigator
National Surgical Adjuvant Breast and Bowel Project Foundation, Inc.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Panitumumab with capecitabine and oxaliplatin (CAPOX) followed by and Panitumumab with capecitabine and radiation in people with Rectal Cancer and Neoplasm Metastasis, run by NSABP Foundation Inc.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 7 Jan 2008. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of patients with clinical complete response rate in tumor in the pelvis at 4 to 6 weeks after completion of radiation therapy. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jan 2008.