NCT01417494

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
102

participants targeted

Target at P50-P75 for phase_2 colorectal-cancer

Timeline
Completed

Started Jul 2011

Typical duration for phase_2 colorectal-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2011

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 13, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 16, 2011

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2014

Completed
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2016

Completed
Last Updated

November 3, 2020

Status Verified

October 1, 2020

Enrollment Period

3.2 years

First QC Date

August 13, 2011

Last Update Submit

October 30, 2020

Conditions

Colorectal Cancer

Keywords

adenocarcinoma of the colonstage IVA colon cancerstage IVB colon canceradenocarcinoma of the rectumstage IVA rectal cancerstage IVB rectal cancer

Outcome Measures

Primary Outcomes (3)

  • 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

Secondary Outcomes (3)

  • Toxicity

    4 months

  • Time to deterioration of autonomy

    4 months

  • Survival with no deterioration of autonomy

    4 months

Study Arms (2)

Chemotherapy associated with bevacizumab

EXPERIMENTAL

Chemotherapy (FOLFIRI, FOLFOX, LV5FU2) associated with bevacizumab

Drug: Chemotherapy ( FOLFIRI regimen, FOLFOX regimen or LV5FU2 regimen) + bevacizumab

Chemotherapy

ACTIVE COMPARATOR

Chemotherapy (FOLFIRI, FOLFOX, LV5FU2)

Drug: Chemotherapy ( FOLFIRI regimen, FOLFOX regimen or LV5FU2 regimen)

Interventions

Chemotherapy ( FOLFIRI regimen, FOLFOX regimen or LV5FU2 regimen)DRUG
Chemotherapy
Chemotherapy ( FOLFIRI regimen, FOLFOX regimen or LV5FU2 regimen) + bevacizumabDRUG
Chemotherapy associated with bevacizumab

Eligibility Criteria

Age75 Years - 120 Years
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
DISEASE CHARACTERISTICS: * Histologically confirmed metastatic colorectal adenocarcinoma * Unresectable disease * 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: * Hypertension not adequately controlled * Myocardial infarction within the past 6 months * Poorly controlled angina * Decompensated congestive cardiac insufficiency * No history of arterial thromboembolism or any of the following within the past 12 months: * Cerebrovascular accident * Transient ischemic attack * Subarachnoid hemorrhage * 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 6 months since adjuvant chemotherapy after resection of the primary tumor * More than 4 weeks since major surgery, excluding biopsy * More than 4 weeks since radiotherapy

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Hôpital Avicenne

Bobigny, 93000, France

Location

Related Publications (1)

  • 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.

    PMID: 29718089RESULT

MeSH Terms

Conditions

Colorectal NeoplasmsColonic NeoplasmsRectal Neoplasms

Interventions

Drug TherapyFolfox protocolBevacizumab

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Intervention Hierarchy (Ancestors)

TherapeuticsAntibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Officials

  • Thomas Aparicio

    Hopital Avicenne

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 13, 2011

First Posted

August 16, 2011

Study Start

July 1, 2011

Primary Completion

September 1, 2014

Study Completion

April 1, 2016

Last Updated

November 3, 2020

Record last verified: 2020-10

Locations

FR(1)