Metastatic Colorectal CancerPhase 2ACTIVENCT01144195
A Clinical Trial of Panitumumab in Combination With FOLFIRI Chemotherapy as Second Line Treatment in Subjects With Metastatic Colorectal Cancer Expressing Wild-type KRAS and Who Had Progressed ≥ 6 Months After the Last Dose of the First Line Chemotherapy
A Phase 2 study testing Panitumumab + FOLFIRI in people with Metastatic Colorectal Cancer, run by Associacio catalana per a la recerca oncologica i les seves implicacions sanitaries i socials at 1 site in Spain.
Trial summary
First line chemotherapy treatment regimens for metastatic colorectal cancer (mCRC) present disease-free survival of more than 10 months, and as much as 12 and 15 months for many patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Colorectal Cancer
- What is being tested?
- Panitumumab + FOLFIRI
- Type of treatment
- Injection or infusion
- How many people
- 80 participants
- Where
- 1 siteSpain
- Study dates
- Sep 2009to Dec 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
- Men or women 18 years of age or older
- Competent to comprehend, sign, and date an Independent Ethics Committee (IEC)/Institutional Review Board (IRB)-approved informed consent form
- Adenocarcinoma of the colon or rectum confirmed histologically or cytologically by the investigator in subjects presenting metastatic disease
- Subjects with wild-type KRAS tumor status confirmed by central laboratory assessment of paraffin-embedded tumor tissue from the primary tumor or metastasis.
- Radiologically documented progression of the disease according to modified RECIST criteria, 6 months or more after the last dose of chemotherapy for mCRC.
- Only one previous chemotherapy regimen for mCRC, consisting of first line chemotherapy based on fluoropyrimidines and oxaliplatin (prior adjuvant chemotherapy based on fluoropyrimidine is permitted).
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- At least 1 uni-dimensionally measurable lesion of at least 20 mm per modified RECIST criteria. (All sites of disease must be evaluated ≤ 28 days prior to enrollment)
- If subject has prior history of cancer other than colorectal carcinoma, basal cell carcinoma, or cervical carcinoma in situ, then subject must not have had treatment or active disease within 5 years.
- Karnofsky performance status ≥ 70% at the time of enrolment in the study.
- Life expectancy ≥ 3 months
- Prior radiotherapy is acceptable (target lesions should not have been irradiated). At least 14 days must have passed since the administration of the radiotherapy and all signs of early toxicity must have remitted.
- Haematological function (within the 7 days prior to starting the study treatment)::
- Absolute Neutrophil Count(ANC) ≥ 1.5 x 109 cells/L
- Hemoglobin ≥ 9.0 g/dL
- Platelet count ≥ 100 x 109/L
- Kidney function (within the 7 days prior to starting the study treatment):
- Creatinine ≤ 1.5 mg/dL
- Liver function (within the 7 days prior to starting the study treatment):
- Aspartate Aminotransferase(AST) ≤ 3 x Upper Limit of Normal(ULN) (if liver metastases, ≤ 5 x ULN)
- Alanine aminotransferase(ALT) ≤ 3 x ULN (if liver metastases, ≤ 5 x ULN)
- Bilirubin ≤ 2 x ULN
- Metabolic function (within the 7 days prior to starting the study treatment):
- Magnesium ≥ lower limit of normal Lower Limit of normal(LLN),
- Calcium ≥ lower limit of normal (LLN)
Who cannot join
- More than one previous chemotherapy regimen for mCRC consisting of first line chemotherapy based on fluoropyrimidines and/or oxaliplatin (patients receiving first-line chemotherapy based on irinotecan are not candidate for this study).
- Progression of the disease during the first line treatment or less than 6 months after completing the last cycle of first line chemotherapy for mCRC.
- Systemic chemotherapy, hormone treatment, immune therapy or experimental or approved antibodies/proteins (e.g. bevacizumab) ≤ 30 days prior to inclusion.
- Unresolved toxicity from a prior systemic treatment which, in the investigator's opinion, makes the subject unsuitable for inclusion.
- Metastasis in brain/central nervous system (exception: subjects who have been treated, have asymptomatic metastases in the central nervous system and have not been receiving steroids for at least the 30 days prior to inclusion in the study are eligible).
- Significant cardiovascular disease, including unstable angina pectoris or myocardial infarction within the 6 months prior to the start of the study treatment, or history of ventricular arrhythmia.
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- Previous treatment with anti-EGFr antibodies (e.g. cetuximab) or treatment with small molecule Epidermal Growth Factor Receptor (EGFr) tyrosine kinase inhibitors (e.g. erlotinib).
- History of interstitial pneumonia or pulmonary fibrosis or signs of interstitial pneumonia or pulmonary fibrosis on the baseline chest X-ray.
- Treatment for systemic infection within the 14 days prior to starting the study treatment.
- Radiotherapy ≤ 14 days prior to inclusion. Patients must have recovered from all radiotherapy-related toxicity.
- Active inflammatory bowel or other intestinal disease causing chronic diarrhoea (defined as > 4 loose bowel movements per day).
- History of Gilbert's syndrome or dihydropyrimidine deficiency.
- History of any disease which could increase the risks associated to participation in the study or interfere in the interpretation of the study results.
- Known positive test for infection by human immune deficiency virus, hepatitis C, chronic active hepatitis B.
- Subject allergic to the ingredients of the study medication of protein A of Staphylococcus.
- Any comorbid disease which could increase the risk of toxicity.
- The subject presents a disorder of any kind which compromises his/her ability to provide informed consent in writing and/or follow the study procedures.
- Any investigational agent within the 30 days prior to inclusion.
- Major surgery within the 28 days prior to study enrollment.
- Pregnant or breastfeeding women.
- Women or men of childbearing age who do not agree to use appropriate double barrier contraceptive methods (e.g. diaphragm plus condom) or remain abstinent throughout the study and for 6 months after the last administration of the study drug for women and 1 month for men.
- Subjects who do not wish to meet the study requirements or are unable to do so.
Trial locations and contacts
1 site in 1 country.
Spain1 site
Associació Catalana per la Recerca Oncològica i les Seves Implicacions Sanitaries i Socials
Barcelona, Barcelona, 08021
About this study
Official title: An Open-label, Phase II Clinical Trial of Panitumumab in Combination With FOLFIRI Chemotherapy as Second Line Treatment in Subjects With Metastatic Colorectal Cancer Expressing Wild-type KRAS and Who Had Progressed ≥ 6 Months After the Last Dose of the First Line Chemotherapy
First line chemotherapy treatment regimens for metastatic colorectal cancer (mCRC) present disease-free survival of more than 10 months, and as much as 12 and 15 months for many patients.
It is evident that there are 2 groups of patients with metastatic colorectal cancer(mCRC): those who progress during first line treatment or in the 6 months following the last chemotherapy infusion and those who progress after this first 6-month period.
Read more
There are currently no studies evaluating the efficacy of second line chemotherapy regimens according to the duration of response to first line treatment. It seems logical that patients with less aggressive tumours will benefit more from treatments targeting specific proteins, such as panitumumab, due to the shorter duration of these tumours cell cycle, which makes them less sensitive to chemotherapy.
This study is therefore justified to determine an increase in activity and control of the disease in patients who progressed after 6 months of the last first line chemotherapy infusion for metastatic colorectal cancer(mCRC) in subjects expressing wild-type KRAS.
Read the detailed description
This is a Phase II, single-arm, multi-centre study. Patients with metastatic colorectal cancer expressing wild type KRAS will be screened for this trial. KRAS mutation status will be assessed before inclusion and only WILD-TYPE-KRAS subjects will be included. Eligible subjects will be enrolled and treated with combination therapy consisting of Panitumumab and FOLFIRI as second line treatment.
Eligible patients must not have progressed on or within 6 months after receiving first line chemotherapy based on fluoropyrimidines and oxaliplatin (prior adjuvant chemotherapy based on fluoropyrimidine is permitted). Only one previous chemotherapy regimen is permitted. Progression after 6 months receiving first line chemotherapy regimen, should be imaging-based.
Tumor response assessment will be performed by the investigator per the modified Response Evaluation Criteria in Solid Tumors (m-RECIST). Subjects will be evaluated for tumor response every 6 weeks ± 1 week the first 24 weeks and every 8 weeks thereafter (per the modified-RECIST criteria) until progression disease (PD) or withdrawal from the trial. Responding disease will be confirmed no less than 28 days after the criteria for response are first met. Subjects with symptoms suggestive of progression disease(PD) should be evaluated for tumor progression at the time the symptoms occur.
All subjects who permanently discontinue the treatment for any reason, will undergo a safety follow-up assessment 30 days ± 7 days after the last treatment dose Subjects will be followed for disease status and subsequent cancer therapy. All subjects who discontinue all the treatment before disease progression (eg, due to unacceptable toxicities) are followed for progression free survival (PFS) (eg, radiographic tumor assessments) every 12 weeks ± 14 days until disease progression or the end of study (unless the reason for study discontinuation is fully withdrawn consent). After disease progression, all subjects are followed every 12 weeks ± 14 days from the safety follow-up visit until the end of study (approximately 52 weeks after the last subject is enrolled).
- Conditions
- Metastatic Colorectal Cancer
- Being tested
- Panitumumab + FOLFIRI
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Panitumumab + FOLFIRIDrug
Panitumumab will be administered by intravenous (IV) infusion at a dose of 6 mg/kg once every 2 weeks. FOLFIRI chemotherapy will be administered once every 2 weeks after the administration of Panitumumab.
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate
Measured: 3 years
Secondary outcomes (8)
disease control rate
Measured: 3 years
duration of response
Measured: 3 years
time to response
Measured: 3 years
progression-free survival
Measured: 3 years
time to progression
Measured: 3 years
time to treatment failure
Measured: 3 years
duration of stable disease
Measured: 3 years
Incidence of adverse events
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2010 (estimated)
- Study startSep 2009
- Primary completionDec 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic 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
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Associacio catalana per a la recerca oncologica i les seves implicacions sanitaries i socials
- Sponsor type
- University, hospital or other
- Collaborators
- Amgen
- Investigators
- Carles Pericay, MD PhD, Study chair, Corporació Sanitaria Parc Taulí, Sabadell (Spain)Ferran Losa, Dr., Principal investigator, Hospital General de l'HospitaletPilar Vicente, Dra., Principal investigator, Hospital General de GranollersHermini Manzano, Dr., Principal investigator, Hospital Son DuretaJuan Manuel Campos, Dr., Principal investigator, Hospital Arnau de Vilanova (Valencia)Joan Manel Gasent, Dr., Principal investigator, Hospital de DeniaEnrique Barrajón, Dr., Principal investigator, Clínica de BenidormInma Guasch, Dra., Principal investigator, Hospital General de Manresa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01144195
- Sponsor's protocol ID
- ACROSS-08-01
- Other IDs
- 2009-010975-26, 2009
- Acronym
- ACTIVE
- Status last verified
- Nov 2010
- First submitted
- 7 Jun 2010
- Last updated
- 10 Nov 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Phase II Clinical Trial of Panitumumab in Combination With FOLFIRI Chemotherapy as Second Line Treatment in Subjects With Metastatic Colorectal Cancer Expressing Wild-type KRAS and Who Had Progressed ≥ 6 Months After the Last Dose of the First Line Chemotherapy
- ClinicalTrials.gov ID
- NCT01144195
- Acronym / sponsor ID
- ACTIVE / ACROSS-08-01
- Conditions
- Metastatic Colorectal Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Associacio catalana per a la recerca oncologica i les seves implicacions sanitaries i socialsUniversity, hospital or other
- Collaborators
- Amgen
- Study start
- Sep 2009
- Primary completion
- Dec 2011 (estimated)
- First posted
- 15 Jun 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.
First line chemotherapy treatment regimens for metastatic colorectal cancer (mCRC) present disease-free survival of more than 10 months, and as much as 12 and 15 months for many patients.
It is evident that there are 2 groups of patients with metastatic colorectal cancer(mCRC): those who progress during first line treatment or in the 6 months following the last chemotherapy infusion and those who progress after this first 6-month period.
There are currently no studies evaluating the efficacy of second line chemotherapy regimens according to the duration of response to first line treatment. It seems logical that patients with less aggressive tumours will benefit more from treatments targeting specific proteins, such as panitumumab, due to the shorter duration of these tumours cell cycle, which makes them less sensitive to chemotherapy.
This study is therefore justified to determine an increase in activity and control of the disease in patients who progressed after 6 months of the last first line chemotherapy infusion for metastatic colorectal cancer(mCRC) in subjects expressing wild-type KRAS.
Detailed description
This is a Phase II, single-arm, multi-centre study. Patients with metastatic colorectal cancer expressing wild type KRAS will be screened for this trial. KRAS mutation status will be assessed before inclusion and only WILD-TYPE-KRAS subjects will be included. Eligible subjects will be enrolled and treated with combination therapy consisting of Panitumumab and FOLFIRI as second line treatment.
Eligible patients must not have progressed on or within 6 months after receiving first line chemotherapy based on fluoropyrimidines and oxaliplatin (prior adjuvant chemotherapy based on fluoropyrimidine is permitted). Only one previous chemotherapy regimen is permitted. Progression after 6 months receiving first line chemotherapy regimen, should be imaging-based.
Tumor response assessment will be performed by the investigator per the modified Response Evaluation Criteria in Solid Tumors (m-RECIST). Subjects will be evaluated for tumor response every 6 weeks ± 1 week the first 24 weeks and every 8 weeks thereafter (per the modified-RECIST criteria) until progression disease (PD) or withdrawal from the trial. Responding disease will be confirmed no less than 28 days after the criteria for response are first met. Subjects with symptoms suggestive of progression disease(PD) should be evaluated for tumor progression at the time the symptoms occur.
All subjects who permanently discontinue the treatment for any reason, will undergo a safety follow-up assessment 30 days ± 7 days after the last treatment dose Subjects will be followed for disease status and subsequent cancer therapy. All subjects who discontinue all the treatment before disease progression (eg, due to unacceptable toxicities) are followed for progression free survival (PFS) (eg, radiographic tumor assessments) every 12 weeks ± 14 days until disease progression or the end of study (unless the reason for study discontinuation is fully withdrawn consent). After disease progression, all subjects are followed every 12 weeks ± 14 days from the safety follow-up visit until the end of study (approximately 52 weeks after the last subject is enrolled).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- 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 (24 listed)
- Men or women 18 years of age or older
- Competent to comprehend, sign, and date an Independent Ethics Committee (IEC)/Institutional Review Board (IRB)-approved informed consent form
- Adenocarcinoma of the colon or rectum confirmed histologically or cytologically by the investigator in subjects presenting metastatic disease
- Subjects with wild-type KRAS tumor status confirmed by central laboratory assessment of paraffin-embedded tumor tissue from the primary tumor or metastasis.
- Radiologically documented progression of the disease according to modified RECIST criteria, 6 months or more after the last dose of chemotherapy for mCRC.
Key exclusion criteria (22 listed)
- More than one previous chemotherapy regimen for mCRC consisting of first line chemotherapy based on fluoropyrimidines and/or oxaliplatin (patients receiving first-line chemotherapy based on irinotecan are not candidate for this study).
- Progression of the disease during the first line treatment or less than 6 months after completing the last cycle of first line chemotherapy for mCRC.
- Systemic chemotherapy, hormone treatment, immune therapy or experimental or approved antibodies/proteins (e.g. bevacizumab) ≤ 30 days prior to inclusion.
- Unresolved toxicity from a prior systemic treatment which, in the investigator's opinion, makes the subject unsuitable for inclusion.
- Metastasis in brain/central nervous system (exception: subjects who have been treated, have asymptomatic metastases in the central nervous system and have not been receiving steroids for at least the 30 days prior to inclusion in the study are eligible).
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 + FOLFIRIPanitumumab will be administered by intravenous (IV) infusion at a dose of 6 mg/kg once every 2 weeks. FOLFIRI chemotherapy will be administered once every 2 weeks after the administration of Panitumumab. | Drug | – |
Primary outcome
Objective Response Rate
Time frame: 3 years
8 secondary outcomes
disease control rate
Time frame: 3 years
duration of response
Time frame: 3 years
time to response
Time frame: 3 years
progression-free survival
Time frame: 3 years
time to progression
Time frame: 3 years
time to treatment failure
Time frame: 3 years
duration of stable disease
Time frame: 3 years
Incidence of adverse events
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2010.
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CRC
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.
Carles Pericay, MD PhD study chair
Corporació Sanitaria Parc Taulí, Sabadell (Spain)
Ferran Losa, Dr. principal investigator
Hospital General de l'Hospitalet
Pilar Vicente, Dra. principal investigator
Hospital General de Granollers
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 Panitumumab + FOLFIRI in people with Metastatic Colorectal Cancer, run by Associacio catalana per a la recerca oncologica i les seves implicacions sanitaries i socials at 1 site in Spain.
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 24 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: status not confirmed, as of the sponsor's last update on 10 Nov 2010. 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 Spain. 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?
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?
Objective Response Rate (time frame: 3 years). 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 10 Nov 2010.