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Colorectal CancerPhase 2NCT00075595

Fluorouracil, Leucovorin, and Irinotecan in Treating Patients With Recurrent or Refractory Metastatic Unresectable Colorectal Cancer

A Phase 2 study testing FOLFIRI regimen, fluorouracil and irinotecan hydrochloride in people with Colorectal Cancer, run by GERCOR - Multidisciplinary Oncology Cooperative Group at 15 sites in France.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

RATIONALE: Drugs used in chemotherapy, such as fluorouracil, leucovorin, and irinotecan, use different ways to stop tumor cells from dividing so they stop growing or die. Giving more than one chemotherapy drug may kill more tumor cells. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Colorectal Cancer
What is being tested?
FOLFIRI regimen, fluorouracil and irinotecan hydrochloride
How many people
Not given
Where
15 sitesFrance
Study dates
Jun 2002to not given
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 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

DISEASE CHARACTERISTICS:

  • Histologically confirmed colorectal adenocarcinoma
  • Metastatic, unresectable disease
  • Meets 1 of the following criteria:
  • At least 1 unidimensionally measurable metastatic lesion at least 10 mm by spiral scan OR 20 mm by conventional scan
  • Evaluable disease
  • Evidence of disease (e.g., ascites or bone metastases) by imaging techniques
  • Progressive disease as defined by 1 of the following criteria:
  • Progressive disease while receiving first-line chemotherapy
  • Recurrent disease within 6 months after completing adjuvant chemotherapy
  • No symptomatic brain metastases

PATIENT CHARACTERISTICS:

Age

  • 18 to 80

Performance status

  • WHO 0-2

Life expectancy

  • At least 3 months

Hematopoietic

  • Absolute neutrophil count ≥ 1,500/mm^3
  • Platelet count ≥ 100,000/mm^3

Hepatic

  • Bilirubin < 1.5 times upper limit of normal (ULN)
  • Alkaline phosphatase < 3 times ULN

Renal

  • Not specified

Cardiovascular

  • No uncontrolled angina
  • No myocardial infarction within the past 6 months

Gastrointestinal

  • No chronic diarrhea grade 2 or greater
  • No unresolved fully or partially obstructed intestine

Other

  • Not pregnant or nursing
  • Fertile patients must use effective contraception
  • No other underlying disease or medical condition that would preclude study participation
  • No other prior malignancy except curatively treated basal cell cancer or carcinoma in situ of the cervix
  • No psychological, social, familial, or geographical condition that would preclude study follow-up

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • Not specified

Chemotherapy

  • See Disease Characteristics
  • No prior irinotecan

Endocrine therapy

  • Not specified

Radiotherapy

  • At least 3 weeks since prior radiotherapy

Surgery

  • At least 3 weeks since prior surgery

Other

  • No other concurrent clinical trial participation

Trial locations and contacts

15 sites in 1 country.

15 sites in 1 country

France15 sites

  • Hopital Drevon

    Dijon, 21000

  • Centre Hospital Universitaire Hop Huriez

    Lille, 59037

  • Clinique Saint Jean

    Lyon, 69008

  • Hopital Saint Joseph

    Marseille, 13008

  • Intercommunal Hospital

    Montfermeil, 93370

  • American Hospital of Paris

    Neuilly-sur-Seine, F-92202

  • Hopital Europeen Georges Pompidou

    Paris, 75015

  • Hopital Bichat - Claude Bernard

    Paris, 75018

  • Hopital Saint Antoine

    Paris, 75571

  • Hopital Tenon

    Paris, 75970

  • Clinique Ste - Marie

    Pontoise, 95300

  • Polyclinique De Courlancy

    Reims, F-51100

  • Clinique Armoricaine De Radiologie

    Saint-Brieuc, F-22015

  • Clinique de l'Orangerie

    Strasbourg, 67010

  • Centre Medico-Chirurgical Foch

    Suresnes, 92151

Other trials in France

About this study

Official title: Phase II Study of 5FU/Folinic Acid and Irinotecan as Second or Third Line Treatment in Patients With Metastatic, Unresectable, Colorectal Cancer

RATIONALE: Drugs used in chemotherapy, such as fluorouracil, leucovorin, and irinotecan, use different ways to stop tumor cells from dividing so they stop growing or die. Giving more than one chemotherapy drug may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving fluorouracil together with leucovorin and irinotecan works in treating patients with recurrent or refractory metastatic unresectable colorectal cancer.

Read the detailed description

OBJECTIVES:

Primary

  • Determine the time to progression and time to death from progression in patients with recurrent or refractory metastatic unresectable colorectal cancer treated with fluorouracil, leucovorin calcium, and irinotecan.

Secondary

  • Determine the objective response and stabilization rate in patients treated with this regimen.
  • Determine the time to treatment failure in patients treated with this regimen.
  • Determine the duration of response in patients treated with this regimen.
  • Determine overall survival rate in patients treated with this regimen.
  • Determine the incidence of grade 3 or 4 toxicity in patients treated with this regimen.

OUTLINE: This is an open-label, multicenter study.

Patients receive leucovorin calcium IV over 2 hours on day 1, irinotecan IV over 1 hour on days 1 and 3, and fluorouracil IV continuously over 46 hours beginning on day 1. Courses repeat every 2 weeks in the absence of disease progression or unacceptable toxicity.

Patients are followed every 3 months.

PROJECTED ACCRUAL: A total of 78 patients will be accrued for this study within 18 months.

Keywords
stage IV colon cancer, stage IV rectal cancer, recurrent colon cancer, recurrent rectal cancer, adenocarcinoma of the colon, adenocarcinoma of the rectum
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. Time to progression

  2. Time to death from progression

Secondary outcomes (6)

  1. Objective response

  2. Stabilization rate

  3. Time to treatment failure

  4. Duration of response

  5. Overall survival rate

  6. Incidence of grade 3 or 4 toxicity

Timeline

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

  1. First posted12 Jan 2004 (estimated)
  2. Study startJun 2002

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
Masking
None (open label)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00075595
Sponsor's protocol ID
CDR0000347378
Other IDs
FRE-GERCOR-FOLFIRI3-C00-2, EU-20333
Status last verified
Aug 2007
First submitted
9 Jan 2004
Last updated
6 Jan 2009
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing FOLFIRI regimen, fluorouracil and irinotecan hydrochloride in people with Colorectal Cancer, run by GERCOR - Multidisciplinary Oncology Cooperative Group at 15 sites 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: status not confirmed, as of the sponsor's last update on 6 Jan 2009. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 15 sites 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?

Results are not available in the source record.

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?

Time to progression. The study lists 2 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 NCT00075595.

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 6 Jan 2009.

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