AzTrials
AzTrials

Colorectal CancerPhase 2NCT00039208

Combination Chemotherapy in Treating Patients With Colorectal Cancer

A Phase 2 study testing fluorouracil, irinotecan hydrochloride and leucovorin calcium in people with Colorectal Cancer, run by European Organisation for Research and Treatment of Cancer - EORTC at 20 sites in 4 countries.

Completed

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

Official record
Search all trials

Trial summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Giving drugs at the time of day that allows for the best drug response may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Colorectal Cancer
What is being tested?
fluorouracil, irinotecan hydrochloride and leucovorin calcium
How many people
Not given
Where
20 sitesin 4 countries
Study dates
Feb 2002to Aug 2005
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

DISEASE CHARACTERISTICS:

  • Histologically confirmed colorectal cancer
  • Unresectable metastatic or locoregional disease
  • At least 1 measurable lesion outside a previously irradiated area or an area treated with physical devices (e.g., cryotherapy, laser, or thermoablation)
  • No prior enrollment in EORTC-05963
  • No symptomatic brain metastases

PATIENT CHARACTERISTICS:

Age:

  • Over 18

Performance status:

  • WHO 0-2

Life expectancy:

  • Not specified

Hematopoietic:

  • Neutrophil count greater than 2,000/mm^3
  • Platelet count at least 90,000/mm^3

Hepatic:

  • Bilirubin no greater than 2 times upper limit of normal (ULN)

Renal:

  • Creatinine no greater than 1.5 times ULN
  • No uncontrolled hypercalcemia

Cardiovascular:

  • No overt cardiac disease

Pulmonary:

  • No severe respiratory illness

Other:

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • Male patients must use effective barrier contraception during and for up to 6 months after study
  • No baseline diarrhea greater than grade I (must have less than 4 stools per 24 hours)
  • No prior grade III or IV toxicity related to irinotecan
  • No sensory or motor neuropathy with functional impairment
  • No prior hypersensitivity to any study drug
  • No other primary tumor except basal cell skin cancer or carcinoma in situ of the cervix
  • No uncontrolled infectious or chronic disease
  • No psychological, familial, sociological, or geographical condition that would preclude study

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • No concurrent prophylactic growth factor therapy

Chemotherapy:

  • At least 1 month since prior chemotherapy
  • No prior irinotecan, fluorouracil, leucovorin calcium, and oxaliplatin as combination therapy
  • Other prior therapy containing irinotecan and/or oxaliplatin allowed
  • No more than 1 prior chemotherapy regimen for metastatic or locoregional disease
  • Adjuvant chemotherapy considered first-line therapy if tumor relapsed within 6 months of completion of therapy

Endocrine therapy:

  • No concurrent corticosteroids except for emergencies

Radiotherapy:

  • See Disease Characteristics
  • Palliative radiotherapy for bone lesion allowed except for disease progression

Surgery:

  • See Disease Characteristics

Trial locations and contacts

20 sites in 4 countries.

20 sites in 4 countries

Italy8 sites

  • Azienda Sanitaria di Bolzano

    Bolzano, 39100

  • Universita G.D'Annunzio Di Chieti

    Chieti, 66100

  • Ospedale San Carlo Borromeo

    Milano (Milan), 20153

  • Azienda Ospedale S. Luigi at University of Torino

    Orbassano, (Torino), 10043

  • Fondazione Salvatore Maugeri

    Pavia, I-27100

  • Ospedale Oncologico Regionale

    Rionero in Vulture, I-58028

  • Istituto Regina Elena

    Rome, 00161

  • Istituto Clinico Beato Matteo

    Vigevano, 27029

Other trials in Italy

France6 sites

  • Centre Jean Perrin

    Clermont-Ferrand, 63011

  • Centre de Lutte Contre le Cancer Georges-Francois Leclerc

    Dijon, 21079

  • Centre Hospital Regional Universitaire de Limoges

    Limoges, 87042

  • Hopital Saint-Louis

    Paris, 75475

  • Centre Rene Huguenin

    Saint-Cloud, 92211

  • Hopital Paul Brousse

    Villejuif, 94804

Other trials in France

Belgium5 sites

  • Centre Hospitalier Notre Dame - Reine Fabiola

    Charleroi, 6000

  • Clinique Saint-Joseph

    Liège, B 4000

  • CHU Liege - Domaine Universitaire du Sart Tilman

    Liège, B-4000

  • Clinique Sainte Elisabeth

    Namur, 5000

  • Centre Hospitalier Peltzer-La Tourelle

    Verviers, B-4800

Other trials in Belgium

Portugal1 site

  • Hospital Fernando Fonseca

    Amadora, P-2700

Other trials in Portugal

About this study

Official title: Time Finding Study of Chronomodulated Irinotecan, 5 Fluorouracil, Leucovorin and Oxaliplatin as First or Second Chemotherapy Line Against Metastatic Colorectal Cancer

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Giving drugs at the time of day that allows for the best drug response may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells.

PURPOSE: Randomized phase II trial to determine the best time to give irinotecan combined with fluorouracil, leucovorin, and oxaliplatin in treating patients who have colorectal cancer.

Read the detailed description

OBJECTIVES:

  • Determine the role of peak delivery time on the tolerability of irinotecan when administered with chronomodulated fluorouracil, leucovorin calcium, and oxaliplatin as first- or second-line therapy in patients with locoregional or metastatic colorectal cancer.
  • Determine the antitumor activity of this regimen.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to participating center, WHO performance status (0-1 vs 2), and line of treatment (first vs second). Patients are randomized to receive irinotecan at 1 of 6 different times of the day.

Patients receive irinotecan IV over 6 hours on day 1 and fluorouracil IV and leucovorin calcium IV over 11 hours followed by oxaliplatin IV over 11 hours on days 2-5. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Patients are followed every 4 weeks until disease progression and then every 8 weeks thereafter.

PROJECTED ACCRUAL: A maximum of 186 patients (31 per irinotecan administration time) will be accrued for this study within 2 years.

Keywords
stage III colon cancer, stage IV colon cancer, stage III rectal cancer, stage IV rectal cancer, recurrent colon cancer, recurrent 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.

What is being measured

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

  1. Peak delivery time for CPT11 tolerability over the first 3 courses of treatment in patients who started therapy

Secondary outcomes (6)

  1. Peak delivery time for CPT11 tolerability over the first 3 courses of treatment in patients who started therapy, excluding those who stopped prior to course 3 for reasons other than toxicity

  2. Peak delivery time for CPT11 activity over the first 3 courses

  3. Peak delivery time for CPT11 tolerability and efficacy over the first 6 courses

  4. Severe toxic events assessed by CTC v2.0 after each course of chemotherapy

  5. Progression-free survival

  6. Overall survival

Timeline

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

  1. First posted27 Jan 2003 (estimated)
  2. Study startFeb 2002
  3. Primary completionAug 2005

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
IDs, dates and publications
ClinicalTrials.gov ID
NCT00039208
Sponsor's protocol ID
EORTC-05011
Other IDs
EORTC-05011
Status last verified
Jul 2012
First submitted
6 Jun 2002
Last updated
13 Jul 2012
Results posted
No

Publications

  • Garufi C, Focan C, Tumolo S, et al.: Time finding study of chronomodulated irinotecan (I), fluorouracil (F), leucovorin (L) and oxaliplatin (O) (chronoIFLO) against metastatic colorectal cancer: results from randomized EORTC 05011 trial. [Abstract] J Clin Oncol 25 (Suppl 18): A-2566, 2007.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing fluorouracil, irinotecan hydrochloride and leucovorin calcium in people with Colorectal Cancer, run by European Organisation for Research and Treatment of Cancer - EORTC at 20 sites in 4 countries.

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 13 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 20 sites in Italy, France, Belgium, Portugal. 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?

Peak delivery time for CPT11 tolerability over the first 3 courses of treatment in patients who started therapy. 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 NCT00039208, 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 13 Jul 2012.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in