Metastatic Colorectal CancerPhase 2SPECTRANCT00958386
Safety and Efficacy Study of Panitumumab+Irinotecan in Patients Wild-Type (WT) KRAS Metastatic Colorectal Cancer Refractory to Irinotecan Based Chemotherapy (SPECTRA)
A Phase 2 study testing Panitumumab+irinotecan in people with Metastatic Colorectal Cancer, run by Spanish Cooperative Group for the Treatment of Digestive Tumours (TTD) at 1 site in Spain.
Trial summary
The purpose of the study is to evaluate the efficacy and safety of the combination of Panitumumab with Irinotecan in patients with Wild-Type KRAS metastatic colorectal cancer refractory to irinotecan based chemotherapy. 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+irinotecan
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 1 siteSpain
- Study dates
- Aug 2009to Jul 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
- Competent to comprehend, sign, and date an IEC-approved informed consent form.
- Men or women 18 years of age or older at the time the written informed consent is obtained.
- Histologically confirmed metastatic adenocarcinoma of the colon or rectum
- Wild-Type KRAS (No mutation) by allelic discrimination on tumor DNA.
- Karnofsky performance status ≥ 70% at the time of enrolment in the study.
- Within seven days prior to initiating study treatment:
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- Adequate bone marrow function: neutrophils ≥ 1.5x109/ L; platelets ≥ 100x109/L; hemoglobin ≥ 9g/dL.
- Hepatic functions as follows: total bilirubin count ≤ 1.5 x ULN; ALAT and ASAT ≤ 2.5 x ULN (≤5 x ULN in case of liver metastasis).
- Renal function: serum creatinine ≤1.5 ULN
- Metabolic functions: magnesium ≥ lower limit of normal (LLN), calcium ≥ lower limit of normal (LLN)
- Life expectancy ≥ 3 months.
Who cannot join
- Prior malignant tumor in the last 5 years, except a history of basal cell carcinoma of the skin or pre-invasive cervical cancer.
- Unresolved toxicities from prior systemic therapy that, in the opinion of the investigator, does not qualify the patient for inclusion.
- Documented or suspected central nervous system metastases.
- Hormonal therapy, immunotherapy or experimental or approved proteins/antibodies (eg, Bevacizumab) ≤ 30 days before inclusion.
- Significant cardiovascular disease including unstable angina or myocardial infarction within 12 months before initiating study treatment or a history of ventricular arrhythmia.
- Prior anti-EGFr antibody therapy (eg, Cetuximab) or treatment small molecule EGFr tyrosine kinase inhibitors (eg, Erlotinib) or EGFR signal transduction inhibitors. Subjects who discontinue their first dose of anti-EGFR therapy (Cetuximab) because of an infusion reaction may participate in this clinical trial.
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- Paraffin-embedded tissue or unstained tumor slides from primary or metastatic tumor not available (blocks available for Translational research).
- History of interstitial pneumonitis or pulmonary fibrosis or evidence of interstitial pneumonitis or pulmonary fibrosis on baseline chest CT scan.
- Treatment for systemic infection within 14 days before initiating study treatment.
- Acute or sub-acute intestinal occlusion and /or active inflammatory bowel disease or other bowel disease causing chronic diarrhoea (defined as > 4 loose stools per day).
- History of Gilbert's syndrome or dihydropyrimidine deficiency.
- History of any medical condition that may increase the risks associated with study participation or may interfere with the interpretation of the study results.
- Known positive test for human immunodeficiency virus infection, hepatitis C virus, and chronic active hepatitis B infection.
- Subject allergic to the ingredients of the study medication or to Staphylococcus protein A.
- Any co-morbid disease that would increase risk of toxicity.
- Any kind of disorder that compromises the ability of the subject to give written informed consent and/or comply with the study procedures.
- Any investigational agent within 30 days before initiation of the treatment.
- Subject who is pregnant or breast feeding.
- Surgery (excluding diagnostic biopsy or central venous catheter placement) and/or radiotherapy within 28 days prior to initiation of study treatment.
- Woman or man of childbearing potential not consenting to use adequate contraceptive precautions i.e. double barrier contraceptive methods (e.g. diaphragm plus condom), or abstinence during the course of the study and for 6 months after the last study drug administration for women, and 1 month for men.
- Subject unwilling or unable to comply with study requirements.
- Psychological, familial, sociological, or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial.
Trial locations and contacts
1 site in 1 country.
Spain1 site
Spanish Cooperative Group for Gastrointestinal Tumour Therapy
Madrid, 28046
About this study
Official title: Open, Multicenter Phase II Study to Evaluate the Efficacy and Safety of the Combination of Panitumumab With Irinotecan in Patients With Wild-Type KRAS Metastatic Colorectal Cancer Refractory to Irinotecan Based Chemotherapy
The purpose of the study is to evaluate the efficacy and safety of the combination of Panitumumab with Irinotecan in patients with Wild-Type KRAS metastatic colorectal cancer refractory to irinotecan based chemotherapy.
- Conditions
- Metastatic Colorectal Cancer
- Being tested
- Panitumumab+irinotecan
- Keywords
- colorectal cancer, Panitumumab, irinotecan
- 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+irinotecanDrug
Panitumumab will be administered as a 60 minute ± 15 minutes IV infusion, just prior to administration of chemotherapy at a dose of 6 mg/kg on day 1 of each cycle. A cycle of Panitumumab is defined as 14 days.
Irinotecan chemotherapy (180 mg/m2 in 90 min on day 1 of each cycle) will be administered after the administration of Panitumumab.
Each treatment cycle will have a duration of 14 days.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Panitumumab+irinotecan Receives: Drug: Panitumumab+irinotecan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate
Measured: 2009-2012
Secondary outcomes (10)
disease control rate
Measured: 2009-2012
duration of response
Measured: 2009-2012
time to progression
Measured: 2009-2012
time to response
Measured: 2009-2012
time to treatment failure
Measured: 2009-2012
duration of stable disease
Measured: 2009-2012
Progression free survival
Measured: 2009-2012
Overall survival
Measured: 2009-2012
Safety profile
Measured: 2009-2012
Evaluation of molecular predictive markers
Measured: 2009-2012
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2009 (estimated)
- Study startAug 2009
- Primary completionJul 2014
- Study completionJul 2014
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
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Spanish Cooperative Group for the Treatment of Digestive Tumours (TTD)
- Sponsor type
- University, hospital or other
- Collaborators
- Amgen
- Responsible party
- Sponsor
- Investigators
- Josep Tabernero, MD, phD, Study chair, Hospital Vall de Hebrón. Barcelona. SpainEnrique Aranda, MD; phD, Study chair, Hospital Reina Sofía. Cordoba. Madrid
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00958386
- Sponsor's protocol ID
- TTD-08-06
- Acronym
- SPECTRA
- Status last verified
- Mar 2015
- First submitted
- 12 Aug 2009
- Last updated
- 24 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open, Multicenter Phase II Study to Evaluate the Efficacy and Safety of the Combination of Panitumumab With Irinotecan in Patients With Wild-Type KRAS Metastatic Colorectal Cancer Refractory to Irinotecan Based Chemotherapy
- ClinicalTrials.gov ID
- NCT00958386
- Acronym / sponsor ID
- SPECTRA / TTD-08-06
- Conditions
- Metastatic Colorectal Cancer
- Keywords
- colorectal cancer, Panitumumab, irinotecan
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Spanish Cooperative Group for the Treatment of Digestive Tumours (TTD)University, hospital or other
- Collaborators
- Amgen
- Study start
- Aug 2009
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 13 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 the study is to evaluate the efficacy and safety of the combination of Panitumumab with Irinotecan in patients with Wild-Type KRAS metastatic colorectal cancer refractory to irinotecan based chemotherapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Panitumumab+irinotecanPanitumumab+irinotecan |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Competent to comprehend, sign, and date an IEC-approved informed consent form.
- Men or women 18 years of age or older at the time the written informed consent is obtained.
- Histologically confirmed metastatic adenocarcinoma of the colon or rectum
- Wild-Type KRAS (No mutation) by allelic discrimination on tumor DNA.
- Karnofsky performance status ≥ 70% at the time of enrolment in the study.
Key exclusion criteria (22 listed)
- Prior malignant tumor in the last 5 years, except a history of basal cell carcinoma of the skin or pre-invasive cervical cancer.
- Unresolved toxicities from prior systemic therapy that, in the opinion of the investigator, does not qualify the patient for inclusion.
- Documented or suspected central nervous system metastases.
- Hormonal therapy, immunotherapy or experimental or approved proteins/antibodies (eg, Bevacizumab) ≤ 30 days before inclusion.
- Significant cardiovascular disease including unstable angina or myocardial infarction within 12 months before initiating study treatment or a history of ventricular arrhythmia.
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+irinotecanPanitumumab will be administered as a 60 minute ± 15 minutes IV infusion, just prior to administration of chemotherapy at a dose of 6 mg/kg on day 1 of each cycle. A cycle of Panitumumab is defined as 14 days. Irinotecan chemotherapy (180 mg/m2 in 90 min on day 1 of each cycle) will be administered after the administration of Panitumumab. Each treatment cycle will have a duration of 14 days. | Drug | 1 |
Primary outcome
Objective response rate
Time frame: 2009-2012
10 secondary outcomes
disease control rate
Time frame: 2009-2012
duration of response
Time frame: 2009-2012
time to progression
Time frame: 2009-2012
time to response
Time frame: 2009-2012
time to treatment failure
Time frame: 2009-2012
duration of stable disease
Time frame: 2009-2012
Progression free survival
Time frame: 2009-2012
Overall survival
Time frame: 2009-2012
Safety profile
Time frame: 2009-2012
Evaluation of molecular predictive markers
Time frame: 2009-2012
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 24 Mar 2015.
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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.
Josep Tabernero, MD, phD study chair
Hospital Vall de Hebrón. Barcelona. Spain
Enrique Aranda, MD; phD study chair
Hospital Reina Sofía. Cordoba. Madrid
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+irinotecan in people with Metastatic Colorectal Cancer, run by Spanish Cooperative Group for the Treatment of Digestive Tumours (TTD) 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 11 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: finished, as of the sponsor's last update on 24 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 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?
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 rate (time frame: 2009-2012). 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 24 Mar 2015; AzTrials last refreshed its copy on 8 Nov 2026.