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AzTrials

Colorectal CancerPhase 2NCT01417494

1st Line Chemotherapy Alone or With Bevacizumab in Treating Older Patients With Metastatic Colorectal Cancer

A Phase 2 study testing Chemotherapy ( FOLFIRI regimen, FOLFOX regimen or LV5FU2 regimen) and Chemotherapy ( FOLFIRI regimen, FOLFOX regimen or LV5FU2 regimen) + bevacizumab in people with Colorectal Cancer, run by Federation Francophone de Cancerologie Digestive at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 75 to 120 years
Conditions the study is for
Colorectal Cancer
What is being tested?
Chemotherapy ( FOLFIRI regimen, FOLFOX regimen or LV5FU2 regimen) and Chemotherapy ( FOLFIRI regimen, FOLFOX regimen or LV5FU2 regimen) + bevacizumab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
102 participants
Where
1 siteFrance
Study dates
Jul 2011to Apr 2016
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 75 to 120 years
  • All sexes
  • No healthy volunteers
  • Older adult

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

Trial locations and contacts

1 site in 1 country.

France1 site

  • Hôpital Avicenne

    Bobigny, 93000

Other trials in France

About this study

Official title: Evaluation of Bevacizumab Combined With First Line Chemotherapy in Patients Aged 75 and Over Suffering From Metastatic Colorectal Adenocarcinoma. Phase II Randomized - Intergroup Trial: FFCD, FNCLCC, GERICO

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.

Read the detailed description

OBJECTIVES:

Primary

  • To evaluate composite efficacy and safety, in terms of objective response or tumoral stability by RECIST criteria and no deterioration in the Spitzer QoL Index score of ≥ 2 points at 4 months, in older patients with unresectable metastatic colorectal adenocarcinoma treated with bevacizumab and first-line chemotherapy.
  • To evaluate tolerance, in terms of no grade 4 arterial hypertension, grade 3-4 thromboembolic event, grade 3-4 cardiac insufficiency, and hospitalization not linked to chemotherapy, in these patients.

Secondary

  • To evaluate toxicity in these patients.
  • To assess time to deterioration of autonomy in these patients.
  • To assess survival with no deterioration of autonomy of these patients.
  • To evaluate time to deterioration of quality of life of these patients.
  • To evaluate percentage of patients who received at least 2/3 of the protocol treatment at month 4.
  • To assess time to treatment failure in these patients.
  • To assess progression-free survival and global survival of these patients.

Tertiary

  • To test for predictive factors of treatment success identified during the geriatric evaluation, according to the main judgment criterion, and analysis of the evolution of geriatric parameters during follow-up int these patients. (Exploratory)

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:
  • Simplified LV5FU2 comprising leucovorin calcium IV over 2 hours on days 1 and 15 and fluorouracil IV over 46 hours beginning on days 1 and 15.
  • FOLFIRI comprising leucovorin calcium IV over 2 hours on days 1 and 15; irinotecan hydrochloride IV over 2 hours on days 1 and 15; and fluorouracil IV over 46 hours beginning on days 1 and 15.
  • FOLFOX4 comprising oxaliplatin IV over 2 hours on days 1 and 15; leucovorin calcium IV over 2 hours on days 1 and 15; and fluorouracil IV over 46 hours beginning on days 1 and 15.

All treatment regimens repeat every 4 weeks for at least 6 months in the absence of disease progression or unacceptable toxicity.

  • Arm B: Patients receive chemotherapy as in arm A. Patients also receive bevacizumab IV over 90 minutes on days 1 and 15. Treatment repeats 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.

Being tested
Chemotherapy ( FOLFIRI regimen, FOLFOX regimen or LV5FU2 regimen), Chemotherapy ( FOLFIRI regimen, FOLFOX regimen or LV5FU2 regimen) + bevacizumab
Keywords
adenocarcinoma of the colon, stage IVA colon cancer, stage IVB colon cancer, adenocarcinoma of the rectum, stage IVA rectal cancer, stage IVB rectal cancer
Medical subject headings
Colorectal Neoplasms, Colonic Neoplasms, Rectal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

  • Chemotherapy ( FOLFIRI regimen, FOLFOX regimen or LV5FU2 regimen) + bevacizumabDrug

Study groups in NCT01417494
Study groupRoleWhat they receive
Chemotherapy associated with bevacizumabExperimentalChemotherapy (FOLFIRI, FOLFOX, LV5FU2) associated with bevacizumab
Receives: Drug: Chemotherapy ( FOLFIRI regimen, FOLFOX regimen or LV5FU2 regimen) + bevacizumab
ChemotherapyActive comparatorChemotherapy (FOLFIRI, FOLFOX, LV5FU2)
Receives: Drug: Chemotherapy ( FOLFIRI regimen, FOLFOX regimen or LV5FU2 regimen)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Efficacy, in terms of objective response or tumoral stability by RECIST criteria

    Measured: 4 months

  2. Deterioration in the Spitzer QoL Index score of ≥ 2 points at baseline and at 4 months

    Measured: 4 months

  3. 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

    Measured: 4 months

Secondary outcomes (3)

  1. Toxicity

    Measured: 4 months

  2. Time to deterioration of autonomy

    Measured: 4 months

  3. Survival with no deterioration of autonomy

    Measured: 4 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Aug 2011 (estimated)
  2. Study startJul 2011
  3. Primary completionSep 2014
  4. Study completionApr 2016

Resources

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
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
102 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01417494
Sponsor's protocol ID
CDR0000706869
Other IDs
FFCD-PRODIGE-20, EU-21120, 2010-022080-34
Status last verified
Oct 2020
First submitted
13 Aug 2011
Last updated
3 Nov 2020
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 29718089

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Chemotherapy ( FOLFIRI regimen, FOLFOX regimen or LV5FU2 regimen) and Chemotherapy ( FOLFIRI regimen, FOLFOX regimen or LV5FU2 regimen) + bevacizumab in people with Colorectal Cancer, run by Federation Francophone de Cancerologie Digestive at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

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 3 Nov 2020. 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 France. 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?

Efficacy, in terms of objective response or tumoral stability by RECIST criteria (time frame: 4 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01417494, which also lists 1 linked publication.

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 3 Nov 2020.

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