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| ID | Type | Description | Link |
|---|---|---|---|
| FFCD-PRODIGE-20 | Other Identifier | FFCD | |
| EU-21120 | Other Identifier | FFCD | |
| 2010-022080-34 | EudraCT Number |
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| Name | Class |
|---|---|
| Roche Pharma AG | INDUSTRY |
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RATIONALE: Drugs used in chemotherapy, such as leucovorin calcium, fluorouracil, irinotecan hydrochloride, and oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Giving bevacizumab together with combination chemotherapy may be a better way to block tumor growth. It is not yet known whether combination chemotherapy is more effective when given together with or without bevacizumab in treating patients with colorectal cancer.
PURPOSE: This randomized phase II trial is studying the side effects of giving bevacizumab together with first-line chemotherapy and to see how well it works in treating older patients with metastatic colorectal cancer.
OBJECTIVES:
Primary
Secondary
Tertiary
OUTLINE: This is a multicenter study. Patients are stratified according to chemotherapy (monotherapy vs double chemotherapy), primary tumor (resected vs non-resected), and quality-of-life score evaluated by the Spitzer QoL Index (0-3 vs 4-7 vs 8-10). Patients are randomized to 1 of 2 treatment arms.
Arm A: Patients receive 1 of the following regimens according to the discretion of the investigator:
All treatment regimens repeat every 4 weeks for at least 6 months in the absence of disease progression or unacceptable toxicity.
Quality of life is assessed periodically. Blood specimens are collected for evaluation of the quantification of circulating cells for early prediction of response to treatment.
After completion of study therapy, patients are followed up every 2-3 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Chemotherapy associated with bevacizumab | Experimental | Chemotherapy (FOLFIRI, FOLFOX, LV5FU2) associated with bevacizumab |
|
| Chemotherapy | Active Comparator | Chemotherapy (FOLFIRI, FOLFOX, LV5FU2) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Chemotherapy ( FOLFIRI regimen, FOLFOX regimen or LV5FU2 regimen) | Drug |
| ||
| Chemotherapy ( FOLFIRI regimen, FOLFOX regimen or LV5FU2 regimen) + bevacizumab |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy, in terms of objective response or tumoral stability by RECIST criteria | 4 months | |
| Deterioration in the Spitzer QoL Index score of ≥ 2 points at baseline and at 4 months | 4 months | |
| Tolerance, in terms of no grade 4 arterial hypertension, grade 3-4 thromboembolic event, grade 3-4 cardiac insufficiency, and hospitalization not related to chemotherapy | 4 months |
| Measure | Description | Time Frame |
|---|---|---|
| Toxicity | 4 months | |
| Time to deterioration of autonomy | 4 months | |
| Survival with no deterioration of autonomy |
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DISEASE CHARACTERISTICS:
Histologically confirmed metastatic colorectal adenocarcinoma
Measurable disease by RECIST criteria
No cerebral metastasis
PATIENT CHARACTERISTICS:
ECOG performance status 0-2
Life expectancy ≥ 3 months
Polynuclear neutrophils > 1,500/mm^3
Platelet count > 100,000/mm^3
Proteinuria ≤ 1 g on 24-hour urine collection
No unresolved intestinal occlusion or subocclusion
No other progressive or unstabilized malignant tumor within the past 2 years
No progressive gastroduodenal ulcer, wound, or bone fracture
No active cardiac disease including any of the following:
No history of arterial thromboembolism or any of the following within the past 12 months:
No history of distal or visceral ischemic arterial pathology ≥ grade 2 within the past 12 months
No history of life-threatening pulmonary embolism within the past 6 months
Must have completed the geriatric self-administered questionnaire and the geriatric "team" questionnaire (including the Spitzer QoL Index)
PRIOR CONCURRENT THERAPY:
No prior chemotherapy for metastatic disease
More than 4 weeks since major surgery, excluding biopsy
More than 4 weeks since radiotherapy
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| Name | Affiliation | Role |
|---|---|---|
| Thomas Aparicio | Hopital Avicenne | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital Avicenne | Bobigny | 93000 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29718089 | Result | Aparicio T, Bouche O, Taieb J, Maillard E, Kirscher S, Etienne PL, Faroux R, Khemissa Akouz F, El Hajbi F, Locher C, Rinaldi Y, Lecomte T, Lavau-Denes S, Baconnier M, Oden-Gangloff A, Genet D, Paillaud E, Retornaz F, Francois E, Bedenne L; for PRODIGE 20 Investigators. Bevacizumab+chemotherapy versus chemotherapy alone in elderly patients with untreated metastatic colorectal cancer: a randomized phase II trial-PRODIGE 20 study results. Ann Oncol. 2018 Nov 1;29(11):2270. doi: 10.1093/annonc/mdx808. No abstract available. |
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| Drug |
|
| 4 months |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D003110 | Colonic Neoplasms |
| D012004 | Rectal 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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| ID | Term |
|---|---|
| D004358 | Drug Therapy |
| C410216 | Folfox protocol |
| D000068258 | Bevacizumab |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
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