Colorectal NeoplasmsPhase 2VOXELNCT00950820
Study to Evaluate the Effects of Panitumumab if Combined With Chemotherapy for 2nd Treatment of Colorectal Cancer
A Phase 2 study testing Oxaliplatin, Capecitabine, Panitumumab and Oxaliplatin, Capecitabine in people with Colorectal Neoplasms, run by AIO-Studien-gGmbH at 1 site in Germany.
Trial summary
The purpose of this interventional study is to investigate whether there is evidence that panitumumab in combination with XELOX (capecitabine plus oxaliplatin) chemotherapy will safely increase progression-free survival, above that of XELOX alone in subjects with KRAS wild-type metastatic colorectal cancer who have… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Neoplasms
- What is being tested?
- Oxaliplatin, Capecitabine, Panitumumab and Oxaliplatin, Capecitabine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteGermany
- Study dates
- Sep 2009to Mar 2012
- 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
- Male or female patients aged 18 years or more, with histologically or cytologically-confirmed and radiologically-measurable metastatic colorectal cancer.
- One prior chemotherapy regimen for mCRC consisting of first-line fluoropyrimidine and irinotecan based chemotherapy. Subjects must have disease progression (as assessed by the investigator) and must be no candidates for primary metastasectomy.
- Measurable disease according to RECIST 1.1 guidelines. All sites of disease must have been evaluated within 28 days prior to registration / randomization, and diagnosed by the investigator.
- Liver and kidney function within defined ranges and sufficient bone marrow reserve.
Who cannot join
- Central nervous system metastases, or significant cardiovascular disease.
- Prior anti-EGFR antibody therapy (e.g. cetuximab) or treatment with small molecule EGFR tyrosine kinase inhibitors (e.g. erlotinib).
- Prior treatment with oxaliplatin for metastatic disease. Adjuvant therapy with oxaliplatin based combination for non-metastatic disease is allowed if terminated > 6 months prior to initiation of screening and without progression during the treatment with oxaliplatin.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-label Randomized Phase II Study of Panitumumab Plus Oral Capecitabine and Infusional Oxaliplatin (XELOX) or XELOX Alone for Second-line Treatment of Patients With Metastatic Colorectal Cancer (VOXEL-Study)
The purpose of this interventional study is to investigate whether there is evidence that panitumumab in combination with XELOX (capecitabine plus oxaliplatin) chemotherapy will safely increase progression-free survival, above that of XELOX alone in subjects with KRAS wild-type metastatic colorectal cancer who have not responded to or progressed after first line therapy with irinotecan and a fluoropyrimidine.
Further Objectives Exploratory objectives may include investigation of potential correlations between the treatment regimen and epidermal growth factor receptor (EGFR) expression, detection of the functional genetic polymorphisms of the EGFR gene, EGFR gene amplification (FISH), EGFR downstream protein and gene expression parameters, proteomics and epigenetics.
Read the detailed description
Subjects with metastatic colorectal cancer with KRAS-wildtype will be randomized in a 1:1 ratio to receive a 2nd line treatment regimen of panitumumab plus oxaliplatin and capecitabine (XELOX) or XELOX alone. Before randomization tumour of all subjects will be analyzed to detect the KRAS mutational status. Subjects will only be randomized into these two arms if the tumour shows KRAS wild-type. Subjects with KRAS mutant colorectal tumours will receive XELOX alone. Subjects will receive treatment cycles every three weeks. Treatment will continue until subjects are diagnosed with disease progression or intolerable toxicity, at which time the subjects will be withdrawn from the treatment phase. If a subject withdraws from chemotherapy due to toxicity the subjects will be allowed to continue with panitumumab monotherapy with or without one of the chemotherapy components until disease progression. After withdrawing panitumumab and XELOX treatment, all subjects will end the treatment phase and will enter a follow-up phase until 6 months after the last patient stopped treatment (with a safety follow-up visit after 56 days ± 3 days and long term follow-up visits every 12 weeks). During the treatment phase subjects will be evaluated for tumour response every 9 weeks (± one week) through to week 45, and every 12 weeks (± two weeks) thereafter, until disease progression. Subjects with symptoms suggestive of disease progression should be evaluated for tumour response at the time symptoms occur.
- Conditions
- Colorectal Neoplasms
- Being tested
- Oxaliplatin, Capecitabine, Panitumumab, Oxaliplatin, Capecitabine
- Keywords
- Open-label, Phase-II-Study, Randomized, Metastatic, Colorectal, Cancer, Panitumumab, Vectibix®, second-line-treatment, KRAS
- Medical subject headings
- Colorectal Neoplasms, Neoplasm Metastasis, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oxaliplatin, Capecitabine, PanitumumabDrug
Panitumumab at a dose of 9 mg/kg BW every three weeks will be administered on day 1 of each cycle just prior to administration of chemotherapy.
The XELOX regimen is defined as a 2 hour infusion of oxaliplatin 130 mg/m² on day 1 followed by capecitabine 1000 mg/m² bid per os. Capecitabine administration will commence on the evening of day 1 and complete after the morning dose on day 15.
Oxaliplatin, CapecitabineDrug
The XELOX regimen is defined as a 2 hour infusion of oxaliplatin 130 mg/m² on day 1 followed by capecitabine 1000 mg/m² bid per os. Capecitabine administration will commence on the evening of day 1 and complete after the morning dose on day 15.
| Study group | Role | What they receive |
|---|---|---|
| Panitumumab + XELOX | Experimental | KRAS mutational status wild-type: Panitumumab plus Oxaliplatin and Capecitabine (XELOX) Receives: Drug: Oxaliplatin, Capecitabine, Panitumumab |
| XELOX (KRAS mutational status wt) | Other | KRAS mutational status wild-type: Oxaliplatin and Capecitabine (XELOX) Receives: Drug: Oxaliplatin, Capecitabine |
| XELOX (KRAS mutational status mutant) | Other | KRAS mutational status mutant: Oxaliplatin and Capecitabine (XELOX) Receives: Drug: Oxaliplatin, Capecitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival rate at 6 months for subjects with KRAS wild-type tumours
Measured: 6 months
Secondary outcomes (9)
PFS
Measured: end of study
Objective-response-rate
Measured: end of study
Disease-control-rate
Measured: end of study
Time-to-response
Measured: end of study
time-to-progression
Measured: end of study
duration-of-stable-disease
Measured: end of study
time-to-treatment-failure
Measured: end of study
overall-survival
Measured: end of study
safety-endpoints
Measured: end of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2009 (estimated)
- Study startSep 2009
- Primary completionNov 2011
- Study completionMar 2012
Why it stopped: Recruitment rate to low; changed environment made protocol in its current state obsolete
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal NeoplasmsStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- AIO-Studien-gGmbH
- Sponsor type
- University, hospital or other
- Collaborators
- iOMEDICO AG
- Responsible party
- Sponsor
- Investigators
- Ralf Grunewald, PD Dr., Principal investigator, Gemeinschaftspraxis Hämatologie / Onkologie Im Prüfling 17-19 60389 Frankfurt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00950820
- Sponsor's protocol ID
- AIO KRK 0107
- Acronym
- VOXEL
- Status last verified
- Mar 2013
- First submitted
- 31 Jul 2009
- Last updated
- 4 Mar 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label Randomized Phase II Study of Panitumumab Plus Oral Capecitabine and Infusional Oxaliplatin (XELOX) or XELOX Alone for Second-line Treatment of Patients With Metastatic Colorectal Cancer (VOXEL-Study)
- ClinicalTrials.gov ID
- NCT00950820
- Acronym / sponsor ID
- VOXEL / AIO KRK 0107
- Conditions
- Colorectal Neoplasms
- Keywords
- Open-label, Phase-II-Study, Randomized, Metastatic, Colorectal, Cancer, Panitumumab, Vectibix®
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Recruitment rate to low; changed environment made protocol in its current state obsolete
- Enrolment
- 9 participants (actual)
- Lead sponsor
- AIO-Studien-gGmbHUniversity, hospital or other
- Collaborators
- iOMEDICO AG
- Study start
- Sep 2009
- Primary completion
- Nov 2011 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 3 Aug 2009 (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.
The purpose of this interventional study is to investigate whether there is evidence that panitumumab in combination with XELOX (capecitabine plus oxaliplatin) chemotherapy will safely increase progression-free survival, above that of XELOX alone in subjects with KRAS wild-type metastatic colorectal cancer who have not responded to or progressed after first line therapy with irinotecan and a fluoropyrimidine.
Further Objectives Exploratory objectives may include investigation of potential correlations between the treatment regimen and epidermal growth factor receptor (EGFR) expression, detection of the functional genetic polymorphisms of the EGFR gene, EGFR gene amplification (FISH), EGFR downstream protein and gene expression parameters, proteomics and epigenetics.
Detailed description
Subjects with metastatic colorectal cancer with KRAS-wildtype will be randomized in a 1:1 ratio to receive a 2nd line treatment regimen of panitumumab plus oxaliplatin and capecitabine (XELOX) or XELOX alone. Before randomization tumour of all subjects will be analyzed to detect the KRAS mutational status. Subjects will only be randomized into these two arms if the tumour shows KRAS wild-type. Subjects with KRAS mutant colorectal tumours will receive XELOX alone. Subjects will receive treatment cycles every three weeks. Treatment will continue until subjects are diagnosed with disease progression or intolerable toxicity, at which time the subjects will be withdrawn from the treatment phase. If a subject withdraws from chemotherapy due to toxicity the subjects will be allowed to continue with panitumumab monotherapy with or without one of the chemotherapy components until disease progression. After withdrawing panitumumab and XELOX treatment, all subjects will end the treatment phase and will enter a follow-up phase until 6 months after the last patient stopped treatment (with a safety follow-up visit after 56 days ± 3 days and long term follow-up visits every 12 weeks). During the treatment phase subjects will be evaluated for tumour response every 9 weeks (± one week) through to week 45, and every 12 weeks (± two weeks) thereafter, until disease progression. Subjects with symptoms suggestive of disease progression should be evaluated for tumour response at the time symptoms occur.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Panitumumab + XELOX | Experimental | Drug: Oxaliplatin, Capecitabine, PanitumumabKRAS mutational status wild-type: Panitumumab plus Oxaliplatin and Capecitabine (XELOX) |
| XELOX (KRAS mutational status wt) | Other | Drug: Oxaliplatin, CapecitabineKRAS mutational status wild-type: Oxaliplatin and Capecitabine (XELOX) |
| XELOX (KRAS mutational status mutant) | Other | Drug: Oxaliplatin, CapecitabineKRAS mutational status mutant: Oxaliplatin and Capecitabine (XELOX) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male or female patients aged 18 years or more, with histologically or cytologically-confirmed and radiologically-measurable metastatic colorectal cancer.
- One prior chemotherapy regimen for mCRC consisting of first-line fluoropyrimidine and irinotecan based chemotherapy. Subjects must have disease progression (as assessed by the investigator) and must be no candidates for primary metastasectomy.
- Measurable disease according to RECIST 1.1 guidelines. All sites of disease must have been evaluated within 28 days prior to registration / randomization, and diagnosed by the investigator.
- Liver and kidney function within defined ranges and sufficient bone marrow reserve.
Key exclusion criteria (3 listed)
- Central nervous system metastases, or significant cardiovascular disease.
- Prior anti-EGFR antibody therapy (e.g. cetuximab) or treatment with small molecule EGFR tyrosine kinase inhibitors (e.g. erlotinib).
- Prior treatment with oxaliplatin for metastatic disease. Adjuvant therapy with oxaliplatin based combination for non-metastatic disease is allowed if terminated > 6 months prior to initiation of screening and without progression during the treatment with oxaliplatin.
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 |
|---|---|---|
| Oxaliplatin, Capecitabine, PanitumumabPanitumumab at a dose of 9 mg/kg BW every three weeks will be administered on day 1 of each cycle just prior to administration of chemotherapy. The XELOX regimen is defined as a 2 hour infusion of oxaliplatin 130 mg/m² on day 1 followed by capecitabine 1000 mg/m² bid per os. Capecitabine administration will commence on the evening of day 1 and complete after the morning dose on day 15. | Drug | Panitumumab + XELOX |
| Oxaliplatin, CapecitabineThe XELOX regimen is defined as a 2 hour infusion of oxaliplatin 130 mg/m² on day 1 followed by capecitabine 1000 mg/m² bid per os. Capecitabine administration will commence on the evening of day 1 and complete after the morning dose on day 15. | Drug | XELOX (KRAS mutational status mutant), XELOX (KRAS mutational status wt) |
Primary outcome
Progression-free survival rate at 6 months for subjects with KRAS wild-type tumours
Time frame: 6 months
9 secondary outcomes
PFS
Time frame: end of study
Objective-response-rate
Time frame: end of study
Disease-control-rate
Time frame: end of study
Time-to-response
Time frame: end of study
time-to-progression
Time frame: end of study
duration-of-stable-disease
Time frame: end of study
time-to-treatment-failure
Time frame: end of study
overall-survival
Time frame: end of study
safety-endpoints
Time frame: end of study
Results and safety
The study was stopped early (reason given: Recruitment rate to low; changed environment made protocol in its current state obsolete). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2013.
- Related InfoLink provided by the sponsor.
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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.
Ralf Grunewald, PD Dr. principal investigator
Gemeinschaftspraxis Hämatologie / Onkologie Im Prüfling 17-19 60389 Frankfurt
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Oxaliplatin, Capecitabine, Panitumumab and Oxaliplatin, Capecitabine in people with Colorectal Neoplasms, run by AIO-Studien-gGmbH at 1 site in Germany.
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 4 inclusion and 3 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 4 Mar 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
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: Recruitment rate to low; changed environment made protocol in its current state obsolete). 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?
Progression-free survival rate at 6 months for subjects with KRAS wild-type tumours (time frame: 6 months). 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 4 Mar 2013.