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Colorectal CancerPhase 2NCT00303745

Irinotecan With or Without Capecitabine as Second-Line Therapy in Treating Older Patients With Progressive, Metastatic Colorectal Cancer That Cannot Be Removed By Surgery

A Phase 2 study testing capecitabine and irinotecan hydrochloride in people with Colorectal Cancer, run by Federation Francophone de Cancerologie Digestive at 23 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 The sponsor has not verified this record for over two years, so it may be out of date.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 irinotecan and capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. Read more about this study

Who is it for?
Ages 75 years and older
Conditions the study is for
Colorectal Cancer
What is being tested?
capecitabine and irinotecan hydrochloride
How many people
78 participants
Where
23 sitesFrance
Study dates
Jun 2006to 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 75 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

DISEASE CHARACTERISTICS:

  • Histologically confirmed metastatic adenocarcinoma of the colon or rectum
  • Unresectable disease
  • Documented progressive disease during first-line/palliative chemotherapy
  • Measurable disease ≥ 1 cm that is outside prior radiation field
  • No brain metastases

PATIENT CHARACTERISTICS:

  • WHO performance status 0-2
  • Life expectancy ≥ 3 months
  • No contraindication to chemotherapy
  • Creatinine clearance ≥ 40 mL/min
  • Absolute neutrophil count ≥ 1,500/mm^3
  • Platelet count ≥ 100,000/mm^3
  • Alkaline phosphatase ≤ 3 times normal (5 times normal if hepatic involvement)
  • Bilirubin ≤ 1.5 times normal
  • Transaminases ≤ 5 times normal
  • No symptomatic coronary disease or cardiac insufficiency
  • No enteropathy or chronic diarrhea
  • No unresolved intestinal occlusion or subocclusion
  • No history of severe unexpected reaction to a fluoropyrimidine
  • No other active malignancy in the past 2 years
  • No hypersensitivity to irinotecan hydrochloride or its excipients
  • No hypersensitivity to capecitabine or fluorouracil

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • No prior extensive resection
  • No concurrent sorivudine or similar analogs (e.g., brivudine)
  • No other concurrent anticancer therapy
  • Concurrent radiotherapy allowed for nontarget lesions

Trial locations and contacts

23 sites in 1 country.

23 sites in 1 country

France23 sites

  • Centre Hospitalier d'Abbeville

    Abbeville, 80101

  • Polyclinique Bordeaux Nord Aquitaine

    Boucher, 33300

  • Centre Hospitalier Universitaire Ambroise Pare - Boulogne

    Boulogne, F-92104

  • Centre Hospitalier

    Chalon-sur-Saône, F-71321

  • Hopital Antoine Beclere

    Clamart, 92141

  • Hopital Du Bocage

    Dijon, 21034

  • Clinique Pasteur

    Guilherand-Granges, 07500

  • CMC Les Ormeaux

    Le Havre, 76600

  • C. H. Du Mans

    Le Mans, 72037

  • Hopital Robert Boulin

    Libourne, 33500

  • Polyclinique des Quatre Pavillons

    Lormont, 33310

  • CHR D'Orleans - Hopital de la Source

    Orléans, 45100

  • Hopital Europeen Georges Pompidou

    Paris, 75015

  • Hopital Bichat - Claude Bernard

    Paris, 75018

  • CHU Pitie-Salpetriere

    Paris, 75651

  • Hopital Cochin

    Paris, 75674

  • Centre Hospitalier de Perpignan

    Perpignan, 66046

  • Hopital Sebastopol, C.H.U. de Reims

    Reims, 51092

  • Centre Eugene Marquis

    Rennes, 35042

  • Hopital Charles Nicolle

    Rouen, 76031

  • C.H. Senlis

    Senlis, 60309

  • CHRU de Tours - Hopital Trousseau

    Tours, 37044

  • Centre Hospitalier General - St. Nicolas

    Verdun, 55107

Other trials in France

About this study

Official title: Randomized Study of Second-Line Therapy Comprising Irinotecan With or Without Capecitabine in Patients Aged At Least 75 Years With Colorectal Cancer

RATIONALE: Drugs used in chemotherapy, such as irinotecan and capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. It is not yet known whether irinotecan and capecitabine are more effective than irinotecan alone in treating colorectal cancer.

PURPOSE: This randomized phase II trial is studying irinotecan and capecitabine to see how well they work as second-line therapy compared to irinotecan alone in treating older patients with progressive, metastatic colorectal cancer that cannot be removed by surgery.

Read the detailed description

OBJECTIVES:

Primary

  • Compare the objective response or stable disease rate in elderly patients with unresectable, progressive, metastatic colorectal cancer treated with irinotecan hydrochloride with vs without capecitabine.

Secondary

  • Compare the tolerability of these regimens in these patients.
  • Compare the quality of life and ability to maintain self-sufficiency of patients treated with these regimens.
  • Compare the progression-free and overall survival of patients treated with these regimens.

OUTLINE: This is an open-label, randomized, multicenter study. Patients are stratified according to participating center, WHO performance status (0 or 1 vs 2), number of associated comorbidities (Charlson index 0-2 vs > 2), and age (75-79 vs ≥ 80). Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients receive irinotecan hydrochloride IV over 90 minutes on day 1. Treatment repeats every 2 weeks for 2 courses in the absence of disease progression or unacceptable toxicity.
  • Arm II: Patients receive oral capecitabine on days 1-14 and irinotecan hydrochloride IV over 90 minutes on day 1. Treatment repeats every 3 weeks for 2 courses in the absence of disease progression or unacceptable toxicity.

Quality of life is assessed at baseline and then every 12 weeks thereafter.

After completion of study therapy, patients are followed every 12 weeks.

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

Keywords
adenocarcinoma of the colon, recurrent colon cancer, stage IV colon cancer, adenocarcinoma of the rectum, recurrent rectal cancer, stage IV 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. Objective response

  2. Stable disease rate

Secondary outcomes (3)

  1. Tolerability

  2. Quality of life

  3. Progression-free and 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 posted17 Mar 2006 (estimated)
  2. Study startJun 2006

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
Masking
None (open label)
Enrolment
78 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00303745
Sponsor's protocol ID
CDR0000453857
Other IDs
FFCD-0305, EU-20545, EUDRACT-2004-004742-40
Status last verified
Dec 2006
First submitted
15 Mar 2006
Last updated
24 Jul 2008
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing capecitabine and irinotecan hydrochloride in people with Colorectal Cancer, run by Federation Francophone de Cancerologie Digestive at 23 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 24 Jul 2008. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 23 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?

Objective response. 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 NCT00303745.

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 24 Jul 2008.

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