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| ID | Type | Description | Link |
|---|---|---|---|
| EudraCT: 2008-006766-28 |
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| Name | Class |
|---|---|
| Amgen | INDUSTRY |
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The purpose of the study is to evaluate the efficacy and safety of the combination of Panitumumab with FOLFOX 4 Chemotherapy or Panitumumab with FOLFIRI Chemotherapy in Subjects with Wild- Type KRAS Colorectal Cancer and liver-only Metastases.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Panitumumab+FOLFOX 4 |
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| 2 | Experimental | Panitumumab+FOLFIRI |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Panitumumab+FOLFOX-4 | Drug | 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. If the first infusion of panitumumab is well tolerated (without any serious infusion related reactions) all subsequent infusions may be administered over 30 minutes ± 10 minutes. A cycle of panitumumab is defined as 14 days. FOLFOX 4 chemotherapy will be administered on day 1 of each 14-day treatment cycle:
|
| Measure | Description | Time Frame |
|---|---|---|
| Objective response rate | 2009-2013 |
| Measure | Description | Time Frame |
|---|---|---|
| % of patients whose disease becomes resectable | 2009-2013 | |
| Time to resection | 2009-2013 | |
| Duration of response |
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Inclusion Criteria:
Man or woman > 18 years < 75 of age
Competent to comprehend, sign, and date an IEC-approved informed consent form
Histologically confirmed adenocarcinoma of the colon or rectum
Wild Type KRAS status
Metastatic colorectal carcinoma exclusively affecting only the liver, compliant with one of the following criteria
At least 1 uni-dimensionally measurable lesion
Patients with the following characteristics will be included:
Patients with simultaneous liver metastases are eligible, if the primary tumor has been resected at least 1 month prior chemotherapy.
Prior radiotherapy is acceptable.
Patients deemed to have no major contra-indication to liver surgery from a general health perspective.
Karnofsky performance status ≥ 70%
Adequate bone marrow function: neutrophils ≥ 1.5 x109/ L; platelets ≥ 100 x109/ L;hemoglobin ≥ 9g/ dL
Hepatic and metabolic function as follows:
Total bilirubin count ≤ 1.5 x ULN and not increasing more than 25% within the last 4 weeks; ALAT and ASAT < 5 x ULN;
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Albert Abad, MD, phD | ICO-H. Germans Trial i Pujol. Badalona. Spain | Study Chair |
| Alfredo Carrato, MD, phD | Hospial Ramón y Cajal. Madrid. Spain | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Spanish Cooperative Group for Gastrointestinal Tumour Therapy | Madrid | 28046 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31803504 | Derived | Benavides M, Diaz-Rubio E, Carrato A, Abad A, Guillen C, Garcia-Alfonso P, Gil S, Cano MT, Safont MJ, Gravalos C, Manzano JL, Sanchez A, Alcaide J, Lopez R, Massuti B, Sastre J, Martinez E, Escudero P, Mendez M, Aranda E. Tumour location and efficacy of first-line EGFR inhibitors in KRAS/RAS wild-type metastatic colorectal cancer: retrospective analyses of two phase II randomised Spanish TTD trials. ESMO Open. 2019 Dec 1;4(6):e000599. doi: 10.1136/esmoopen-2019-000599. eCollection 2019. | |
| 28633089 |
| Label | URL |
|---|---|
| Related Info | View source |
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|
| Panitumumab+FOLFIRI | Drug | 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. If the first infusion of panitumumab is well tolerated (without any serious infusion related reactions) all subsequent infusions may be administered over 30 minutes ± 10 minutes. A cycle of panitumumab is defined as 14 days. FOLFIRI chemotherapy will be administered on day 1 of each 14-day treatment cycle:
|
|
| 2009-2013 |
| Progression-free survival | 2009-2013 |
| Time to treatment failure | 2009-2013 |
| Time to disease relapse following surgery. | 2009-2013 |
| Adverse Events | 2009-2013 |
| Evaluation of molecular predictive markers for response. | 2009-2013 |
| Derived |
| Carrato A, Abad A, Massuti B, Gravalos C, Escudero P, Longo-Munoz F, Manzano JL, Gomez A, Safont MJ, Gallego J, Garcia-Paredes B, Pericay C, Duenas R, Rivera F, Losa F, Valladares-Ayerbes M, Gonzalez E, Aranda E; Spanish Cooperative Group for the Treatment of Digestive Tumours (TTD). First-line panitumumab plus FOLFOX4 or FOLFIRI in colorectal cancer with multiple or unresectable liver metastases: A randomised, phase II trial (PLANET-TTD). Eur J Cancer. 2017 Aug;81:191-202. doi: 10.1016/j.ejca.2017.04.024. Epub 2017 Jun 19. |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
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