Colorectal CancerPhase 2NCT01215539
Study of Panitumumab-Capecitabine-Oxaliplatin In Wild-Type K-Ras Metastatic Colorectal Cancer Patients
A Phase 2 study testing panitumumab in people with Colorectal Cancer, run by Hellenic Cooperative Oncology Group at 12 sites in Greece.
Trial summary
The purpose of this study is to determine whether panitumumab in combination with capecitabine/oxaliplatin are effective as first-line treatment in wild-type k-ras, metastatic colorectal cancer patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- panitumumab
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 12 sitesGreece
- Study dates
- Sep 2010to Dec 2014
- 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
- Ability to comprehend and sign an informed consent
- Aged 18 years or more
- Histologically or cytologically-confirmed metastatic adenocarcinoma of the colon and/or rectum
- Measurable disease according to the RECIST criteria
- Eastern Cooperative Oncology Group (ECOG) status of 0-2
- Non-mutated k-ras gene (k-ras status will be assessed by DNA sequencing in codons 12 and 13)
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- Haematologic function: ANC >1.5 x 109/L, Leucocyte count >3000/mm3, Haemoglobin >10g/ d L, PLT >100 x 109/ L
- Renal function: serum creatinine ≤1.5xUNL or creatinine clearance > 50ml/min
- Hepatic function:
- Total bilirubin ≤ 1.5 time the upper normal limit (UNL)
- ASAT ≤ 2.5xUNL in absence of liver metastases, or ≤5xUNL in presence of liver metastases
- ALAT ≤ 2.5xUNL in absence of liver metastases, or ≤5xUNL in presence of liver metastases
- Metabolic function:
- Magnesium ≥ lower limit of normal.
- Calcium ≥ lower limit of normal.
Who cannot join
- Central nervous system metastases
- Prior therapy for metastatic disease
- Adjuvant chemotherapy for the last 6 months
- Prior anti-EGFR therapy or treatment with EGFR tyrosine kinase inhibitors
- Prior radiotherapy within 30 days from enrollment
- Clinically significant cardiovascular disease (including myocardial infarction, unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia) <=1 year before enrollment
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- History of interstitial lung disease e.g. pneumonitis or pulmonary fibrosis or evidence of interstitial lung disease on baseline chest CT scan.
- Inflammatory bowel disease or chronic diarrhea
- Dihydropyrimidine deficiency
- Positive test for HIV infection, hepatitis C infection, chronic active hepatitis B infection
- Any kind of disorder compromising the ability of the patient to give informed consent
- Any investigational agent within 30 days prior to initiation of the study
- Any surgical procedure within 28 days prior to initiation of the study
- Subject pregnant or breast feeding, or planning to become pregnant within 6 months after the end of treatment.
- Female subject in childbearing age with a positive pregnancy test at screening or before initiation of study treatment.
- Subject (male or female) not willing to use highly effective methods of contraception (per institutional standard) during treatment and for 6 months (male or female) after the end of treatment.
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
Greece12 sites
General Hospital of Athens "Hippokratio", 2nd Dept of Internal Medicine
Athens, 11527
Sotiria General Hospital, 3rd Dept of Medicine, Oncology Unit
Athens, 11527
General Peripheral Hospital of Athens "Alexandra"
Athens, 11528
Agii Anargiri Cancer Hospital, Oncology Dept
Athens, 14564
Hygeia Hospital, 2nd Dept of Medical Oncology
Athens, 15123
Hygeia Hospital, 3rd Dept of Medical Oncology
Athens, 15123
Metropolitan Hospital, 1st Dept of Medical Oncology
Athens, 18547
Metropolitan Hospital, 2nd Dept of Medical Oncology
Athens, 18547
Chania General Hospital
Chania, 73100
Ioannina University Hospital, Dept of Medical Oncology
Ioannina, 45110
Rio University Hospital, Dept of Oncology
Pátrai, 26500
Papageorgiou General Hospital, Dept of Medical Oncology
Thessaloniki, 56429
About this study
Official title: A SINGLE-ARM, MULTICENTER, PHASE II STUDY OF PANITUMUMAB IN COMBINATION WITH CAPECITABINE / OXALIPLATIN IN FIRST-LINE, WILD-TYPE K-RAS METASTATIC COLORECTAL CANCER PATIENTS.
The purpose of this study is to determine whether panitumumab in combination with capecitabine/oxaliplatin are effective as first-line treatment in wild-type k-ras, metastatic colorectal cancer patients.
Read the detailed description
This is a single-arm trial in which previously untreated, wild-type k-ras metastatic colorectal cancer patients will receive therapy with the combination of panitumumab with capecitabine and oxaliplatin. During the treatment period of 6 cycles, subjects with evidence of complete response, partial response or stable disease will continue to receive the combination of chemotherapy with panitumumab until disease progression, unacceptable toxicity or withdrawal of consent. Those patients with disease stabilization who are not appropriate for chemotherapy may continue with panitumumab alone. Patients with disease progression will be discontinued from chemotherapy and panitumumab and will be followed every 3 months after the last drug administration until death. Tumor response will be assessed according to the RECIST criteria (investigator's read of scans), every 6 weeks through week 18 and every 3 months thereafter, until disease progression. Disease progression will also be evaluated radiographically at the time of clinical suspicion of progression.
- Conditions
- Colorectal Cancer
- Being tested
- panitumumab
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
panitumumabDrug
Panitumumab will be administered by IV infusion on day 1 of each 3-week cycle prior to the administration of chemotherapy. The starting panitumumab dose is 9 mg/kg. Subjects with evidence of complete response, partial response or stable disease will continue to receive the combination of chemotherapy with panitumumab until disease progression, unacceptable toxicity or withdrawal of consent.
| Study group | Role | What they receive |
|---|---|---|
| Panitumumab,capecitabine,oxaliplatin | Experimental | Panitumumab will be administered by IV infusion on day 1 of each 3-week cycle prior to the administration of chemotherapy. The starting panitumumab dose is 9 mg/kg.
Oxaliplatin 130 mg/m2 IV infusion over 2 hours on Day 1 Capecitabine 2000 mg/m2 divided in two doses, orally, on Days 1 - 14 Receives: Drug: panitumumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response
Response will be evaluated using the RECIST criteria. Response rates will be presented as counts and proportions along with 95% exact confidence intervals.
An Objective Response is defined as either a Complete Response or a Partial Response. Analysis will be performed in the intent-to-treat population, i.e. all eligible patients enrolled in the study.
Measured: Tumor response will be assessed every 6 weeks through week 18 and every 3 months thereafter, until disease progression.
Secondary outcomes (4)
Overall Survival (OS)
OS will be calculated from the date of enrolment to the date of death or last contact
Measured: 24 months
Progression-Free Survival(PFS)
PFS will be calculated from the date of enrolment to the date of disease progression, or death, or last contact. Deaths without a documented progression will be treated as events at the time of death for the PFS analysis.
Time to event distributions will be estimated using the Kaplan-Meier method.
Measured: Tumor response will be assessed every 6 weeks through week 18 and every 3 months thereafter, until disease progression.
Adverse Events (AE)of all participants will be recorded and assessed upon signature of the informed consent form, until 30 days after the last administration of study treatment.
Adverse Events will be graded according to the NCI CTCAE v3.0 criteria and will be reported in a frequency table according to the highest severity grade observed per patient
Measured: 18 months
Economic evaluation
The purpose of economic evaluation will be to estimate the total treatment cost of therapy and its componenents from perspective of the health care system and payers. Thus, all resources consumed will be valued to get an idea of the financial implications of therapy.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2010 (estimated)
- Study startSep 2010
- Primary completionAug 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Colorectal 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hellenic Cooperative Oncology Group
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dimitrios Pectasides, Professor, Study chair, General Hospital of Athens"Hippokratio", 2nd Dept of Internal Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01215539
- Sponsor's protocol ID
- HE 6A/09
- Other IDs
- 2009-012655-26, 2009
- Status last verified
- Mar 2015
- First submitted
- 29 Sep 2010
- Last updated
- 18 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Papaxoinis G, Kotoula V, Giannoulatou E, Koliou GA, Karavasilis V, Lakis S, Koureas A, Bobos M, Chalaralambous E, Daskalaki E, Chatzopoulos K, Tsironis G, Pazarli E, Chrisafi S, Samantas E, Kaklamanos IG, Varthalitis I, Konstantara A, Syrigos KN, Pentheroudakis G, Pectasides D, Fountzilas G. Phase II study of panitumumab combined with capecitabine and oxaliplatin as first-line treatment in metastatic colorectal cancer patients: clinical results including extended tumor genotyping. Med Oncol. 2018 May 31;35(7):101. doi: 10.1007/s12032-018-1160-1.
PubMed 29855806
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A SINGLE-ARM, MULTICENTER, PHASE II STUDY OF PANITUMUMAB IN COMBINATION WITH CAPECITABINE / OXALIPLATIN IN FIRST-LINE, WILD-TYPE K-RAS METASTATIC COLORECTAL CANCER PATIENTS.
- ClinicalTrials.gov ID
- NCT01215539
- Acronym / sponsor ID
- HE 6A/09
- Conditions
- Colorectal Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Hellenic Cooperative Oncology GroupUniversity, hospital or other
- Study start
- Sep 2010
- Primary completion
- Aug 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 6 Oct 2010 (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 study is to determine whether panitumumab in combination with capecitabine/oxaliplatin are effective as first-line treatment in wild-type k-ras, metastatic colorectal cancer patients.
Detailed description
This is a single-arm trial in which previously untreated, wild-type k-ras metastatic colorectal cancer patients will receive therapy with the combination of panitumumab with capecitabine and oxaliplatin. During the treatment period of 6 cycles, subjects with evidence of complete response, partial response or stable disease will continue to receive the combination of chemotherapy with panitumumab until disease progression, unacceptable toxicity or withdrawal of consent. Those patients with disease stabilization who are not appropriate for chemotherapy may continue with panitumumab alone. Patients with disease progression will be discontinued from chemotherapy and panitumumab and will be followed every 3 months after the last drug administration until death. Tumor response will be assessed according to the RECIST criteria (investigator's read of scans), every 6 weeks through week 18 and every 3 months thereafter, until disease progression. Disease progression will also be evaluated radiographically at the time of clinical suspicion of progression.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Panitumumab,capecitabine,oxaliplatin | Experimental | Drug: panitumumabPanitumumab will be administered by IV infusion on day 1 of each 3-week cycle prior to the administration of chemotherapy. The starting panitumumab dose is 9 mg/kg. Oxaliplatin 130 mg/m2 IV infusion over 2 hours on Day 1 Capecitabine 2000 mg/m2 divided in two doses, orally, on Days 1 - 14 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Ability to comprehend and sign an informed consent
- Aged 18 years or more
- Histologically or cytologically-confirmed metastatic adenocarcinoma of the colon and/or rectum
- Measurable disease according to the RECIST criteria
- Eastern Cooperative Oncology Group (ECOG) status of 0-2
Key exclusion criteria (16 listed)
- Central nervous system metastases
- Prior therapy for metastatic disease
- Adjuvant chemotherapy for the last 6 months
- Prior anti-EGFR therapy or treatment with EGFR tyrosine kinase inhibitors
- Prior radiotherapy within 30 days from enrollment
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 |
|---|---|---|
| panitumumabPanitumumab will be administered by IV infusion on day 1 of each 3-week cycle prior to the administration of chemotherapy. The starting panitumumab dose is 9 mg/kg. Subjects with evidence of complete response, partial response or stable disease will continue to receive the combination of chemotherapy with panitumumab until disease progression, unacceptable toxicity or withdrawal of consent. | Drug | Panitumumab,capecitabine,oxaliplatin |
Primary outcome
Objective Response
Time frame: Tumor response will be assessed every 6 weeks through week 18 and every 3 months thereafter, until disease progression.
Response will be evaluated using the RECIST criteria. Response rates will be presented as counts and proportions along with 95% exact confidence intervals. An Objective Response is defined as either a Complete Response or a Partial Response. Analysis will be performed in the intent-to-treat population, i.e. all eligible patients enrolled in the study.
4 secondary outcomes
Overall Survival (OS)
Time frame: 24 months
Progression-Free Survival(PFS)
Time frame: Tumor response will be assessed every 6 weeks through week 18 and every 3 months thereafter, until disease progression.
Adverse Events (AE)of all participants will be recorded and assessed upon signature of the informed consent form, until 30 days after the last administration of study treatment.
Time frame: 18 months
Economic evaluation
Time frame: 18 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2015.
- Derived from this study: PubMed 29855806Papaxoinis G, Kotoula V, Giannoulatou E, Koliou GA, Karavasilis V, Lakis S, Koureas A, Bobos M, Chalaralambous E, Daskalaki E, Chatzopoulos K, Tsironis G, Pazarli E, Chrisafi S, Samantas E, Kaklamanos IG, Varthalitis I, Konstantara A, Syrigos KN, Pentheroudakis G, Pectasides D, Fountzilas G. Phase II study of panitumumab combined with capecitabine and oxaliplatin as first-line treatment in metastatic colorectal cancer patients: clinical results including extended tumor genotyping. Med Oncol. 2018 May 31;35(7):101. doi: 10.1007/s12032-018-1160-1.
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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.
Dimitrios Pectasides, Professor study chair
General Hospital of Athens"Hippokratio", 2nd Dept of Internal Medicine
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing panitumumab in people with Colorectal Cancer, run by Hellenic Cooperative Oncology Group at 12 sites in Greece.
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 15 inclusion and 16 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: finished, as of the sponsor's last update on 18 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in Greece. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Objective Response (time frame: Tumor response will be assessed every 6 weeks through week 18 and every 3 months thereafter, until disease progression.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01215539, which also lists 1 linked publication.
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 18 Mar 2015.