Rectal CancerPhase 2NCT00353457
Capecitabine,Oxaliplatin & Erbitux Given Throughout Multi-Modal Therapy for Locally Advanced Rectal Adenocarcinoma
A Phase 2 study testing Capecitabine, Oxaliplatin and Cetuximab and Radiation in people with Rectal Cancer, run by Abramson Cancer Center at Penn Medicine.
Trial summary
This is a phase II study of induction chemotherapy (capecitabine, oxaliplatin and cetuximab (erbitux)) followed by capecitabine, oxaliplatin, cetuximab and radiotherapy followed by surgery followed by adjuvant capecitabine, oxaliplatin and cetuximab for locally advanced resectable rectal cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rectal Cancer
- What is being tested?
- Capecitabine, Oxaliplatin and Cetuximab and Radiation
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- No sites listed yet
- Study dates
- Feb 2006to Jun 2011
- 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
- Histologically confirmed nonmetastatic, measurable, locally advanced (T3 or T4) rectal adenocarcinoma
- If available, tumor tissue must be sent for investigational immunohistochemical evaluations of EGFR status
- The distal border of the tumor must be at or below the peritoneal reflection (defined a with 12 cm of the anal verge by proctoscopy)
- Transmural penetration of the tumor demonstrated by CT + endorectal ultrasound or MRI
- ECOG PS 0-2
- No prior chemotherapy, biologic therapy or radiation therapy
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- Age >= 18 years old
- Laboratory values: ANC >= 1500/mm3; Platelets >= 100,000/mm3; Hgb >= 9 g/dL; Estimated CrCl > 50 mL/min; Serum bilirubin <= 1.5 x ULN; AST and ALT <= 3.0 x ULN; Negative proteinuria based on dip stick reading
- Patients must either be not of child bearing potential or have a negative pregnancy test upon study enrollment. Patients must agree to continue contraception for 30 days from the date of the last study drug administration.
Who cannot join
- Pregnant or lactating woman. Women of childbearing potential with either a positive or no pregnancy test upon study enrollment. Women/men of childbearing potential not using a reliable and appropriate contraceptive method. Patients must agree to continue contraception for 30 days from the date of the last study administration.
- Life expectancy < 3 months
- Serious, uncontrolled, concurrent infection(s)
- Concurrent use of chemotherapy not indicated in the study protocol or any other investigational agents and patients who have received investigational drugs < 4 weeks prior to randomization.
- Prior therapy which specifically and directly targets the EGFR pathway.
- Prior severe infusion reaction to a monoclonal antibody
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- Any prior therapy with Oxaliplatin
- Prior pelvic irradiation for any reason
- Prior unanticipated severe reaction to fluoropyrimidine therapy, or known sensitivity to 5-fluorouracil or known DPD deficiency
- Treatment for other carcinomas within the last five years, except cured non-melanoma skin and treated in-situ cervical cancer
- Participation in any investigational drug study within 4 weeks preceding the start of the study treatment
- Major surgery within 4 weeks of the study treatment, without complete recovery
- Known, existing uncontrolled coagulopathy
- Unwillingness to give written informed consent
- Unwillingness to participate or inability to comply with the protocol for the duration of the study
- Known allergy or hypersensitivity to platinum-containing drugs
- Peripheral sensory neuropathy with functional impairment
- Interstitial pneumonia or extensive and symptomatic interstitial fibrosis of the lung
- Pleural effusions or ascites that causes respiratory compromise
- Acute hepatitis or known HIV
- Any of the following concurrent severe and/or uncontrolled medical conditions which could compromise participation in the study: uncontrolled high blood pressure, history of labile hypertension, or history of poor compliance with anti-hypertensive regimen; unstable angina pectoris; symptomatic congestive heart failure; myocardial infarction < 6 months prior to randomization; serious uncontrolled cardiac arrhythmia; uncontrolled diabetes; active or uncontrolled infection; impairment of gastrointestinal function or GI disease that may significantly alter the absorption of Capecitabine.
- Evidence of CNS metastases or history of uncontrolled seizures, central nervous system disorders or psychiatric disability judged by the investigator to be clinically significant, precluding informed consent, or interfering with compliance of oral drug intake.
About this study
Official title: Phase II Study of Capecitabine, Oxaliplatin and Cetuximab Given Throughout Multi-Modal Therapy for Locally Advanced Rectal Adenocarcinoma
This is a phase II study of induction chemotherapy (capecitabine, oxaliplatin and cetuximab (erbitux)) followed by capecitabine, oxaliplatin, cetuximab and radiotherapy followed by surgery followed by adjuvant capecitabine, oxaliplatin and cetuximab for locally advanced resectable rectal cancer.
- Conditions
- Rectal Cancer
- Being tested
- Capecitabine, Oxaliplatin and Cetuximab, Radiation
- Keywords
- Adjuvant therapy, Rectal cancer, Capecitabine, Oxaliplatin, Cetuximab, Erbitux
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Capecitabine, Oxaliplatin and CetuximabDrug
Capecitabine 825mg/m2 po BID D1-15 of 21 x2 cycles (Cyle 1 and 2), Capecitabine 825mg/m2 po BID weekly Sun PM-Fri AM x2 cycles (cycle 3 and 4), Capecitabine 825mg/m2 po BID D1-15 of 21 x4 cycles (cycle 5,6,7,8) Oxaliplatin 130mg/m2 IV Day 1 every 3 weeks x2 cycles (Cycle 1 and 2), Oxaliplatin 50mg/m2 IV weekly every Monday x2 cycles (Cycle 3 and 4), Oxaliplatin 130mg/m2 IV day 1 every 3 weeks x4 cycles (Cycles 5,6,7,8) Cetuximab 400mg/m2 IV cycle 1 day1, Cetuximab 250mg/m2 Day 1,8,15 of 21 for cycles 1-8
RadiationRadiation
45 Gy in 25 fractions, 3-fraction boost 5.4 Gy
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Capecitabine, Oxaliplatin and Cetuximab Receives: Drug: Capecitabine, Oxaliplatin and Cetuximab; Radiation: Radiation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathologic complete response
Measured: After neoadjuvant treatment
Secondary outcomes (3)
Sphincter function
Measured: After surgery
Type of surgery
Measured: At time of surgery
Disease free survival
Measured: From time of study entry until first documented relapse
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2006 (estimated)
- Study startFeb 2006
- Primary completionJun 2011
- Study completionJun 2011
Why it stopped: new studies were finding that Erbitux was not beneficial
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.
- More trials run by Abramson Cancer Center at Penn MedicineThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abramson Cancer Center at Penn Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Bristol-Myers Squibb, Roche Pharma AG
- Responsible party
- Sponsor
- Investigators
- Daniel G Haller, M.D., Principal investigator, Abramson Cancer Center of University of PennsylvaniaJames M Metz, M.D., Principal investigator, Abramson Cancer Center of University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00353457
- Sponsor's protocol ID
- 803437
- Other IDs
- UPCC 09204
- Status last verified
- Apr 2020
- First submitted
- 14 Jul 2006
- Last updated
- 9 Apr 2020
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of Capecitabine, Oxaliplatin and Cetuximab Given Throughout Multi-Modal Therapy for Locally Advanced Rectal Adenocarcinoma
- ClinicalTrials.gov ID
- NCT00353457
- Acronym / sponsor ID
- 803437
- Conditions
- Rectal Cancer
- Keywords
- Adjuvant therapy, Rectal cancer, Capecitabine, Oxaliplatin, Cetuximab, Erbitux
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: new studies were finding that Erbitux was not beneficial
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Abramson Cancer Center at Penn MedicineUniversity, hospital or other
- Collaborators
- Bristol-Myers Squibb, Roche Pharma AG
- Study start
- Feb 2006 (actual)
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 18 Jul 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.
This is a phase II study of induction chemotherapy (capecitabine, oxaliplatin and cetuximab (erbitux)) followed by capecitabine, oxaliplatin, cetuximab and radiotherapy followed by surgery followed by adjuvant capecitabine, oxaliplatin and cetuximab for locally advanced resectable rectal cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Drug: Capecitabine, Oxaliplatin and Cetuximab, Radiation: RadiationCapecitabine, Oxaliplatin and Cetuximab |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Histologically confirmed nonmetastatic, measurable, locally advanced (T3 or T4) rectal adenocarcinoma
- If available, tumor tissue must be sent for investigational immunohistochemical evaluations of EGFR status
- The distal border of the tumor must be at or below the peritoneal reflection (defined a with 12 cm of the anal verge by proctoscopy)
- Transmural penetration of the tumor demonstrated by CT + endorectal ultrasound or MRI
- ECOG PS 0-2
Key exclusion criteria (22 listed)
- Pregnant or lactating woman. Women of childbearing potential with either a positive or no pregnancy test upon study enrollment. Women/men of childbearing potential not using a reliable and appropriate contraceptive method. Patients must agree to continue contraception for 30 days from the date of the last study administration.
- Life expectancy < 3 months
- Serious, uncontrolled, concurrent infection(s)
- Concurrent use of chemotherapy not indicated in the study protocol or any other investigational agents and patients who have received investigational drugs < 4 weeks prior to randomization.
- Prior therapy which specifically and directly targets the EGFR pathway.
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 |
|---|---|---|
| Capecitabine, Oxaliplatin and CetuximabCapecitabine 825mg/m2 po BID D1-15 of 21 x2 cycles (Cyle 1 and 2), Capecitabine 825mg/m2 po BID weekly Sun PM-Fri AM x2 cycles (cycle 3 and 4), Capecitabine 825mg/m2 po BID D1-15 of 21 x4 cycles (cycle 5,6,7,8) Oxaliplatin 130mg/m2 IV Day 1 every 3 weeks x2 cycles (Cycle 1 and 2), Oxaliplatin 50mg/m2 IV weekly every Monday x2 cycles (Cycle 3 and 4), Oxaliplatin 130mg/m2 IV day 1 every 3 weeks x4 cycles (Cycles 5,6,7,8) Cetuximab 400mg/m2 IV cycle 1 day1, Cetuximab 250mg/m2 Day 1,8,15 of 21 for cycles 1-8 | Drug | Arm 1 |
| Radiation45 Gy in 25 fractions, 3-fraction boost 5.4 Gy | Radiation | Arm 1 |
Primary outcome
Pathologic complete response
Time frame: After neoadjuvant treatment
3 secondary outcomes
Sphincter function
Time frame: After surgery
Type of surgery
Time frame: At time of surgery
Disease free survival
Time frame: From time of study entry until first documented relapse
Results and safety
The study was stopped early (reason given: new studies were finding that Erbitux was not beneficial). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2020.
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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.
Daniel G Haller, M.D. principal investigator
Abramson Cancer Center of University of Pennsylvania
James M Metz, M.D. principal investigator
Abramson Cancer Center of University of Pennsylvania
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Capecitabine, Oxaliplatin and Cetuximab and Radiation in people with Rectal Cancer, run by Abramson Cancer Center at Penn Medicine.
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 9 inclusion and 22 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: stopped early, as of the sponsor's last update on 9 Apr 2020. 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 stopped early (reason given: new studies were finding that Erbitux was not beneficial). Results are not available in the source record.
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?
Pathologic complete response (time frame: After neoadjuvant treatment). 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 9 Apr 2020.