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Colorectal CancerPhase 2/3NCT00274872

Combination Chemotherapy in Treating Patients With Metastatic Colorectal Cancer That Cannot Be Removed By Surgery

A Phase 2/3 study testing fluorouracil, leucovorin calcium and oxaliplatin in people with Colorectal Cancer, run by GERCOR - Multidisciplinary Oncology Cooperative Group at 17 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 The sponsor has not verified this record for over two years, so it may be out of date.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 oxaliplatin, leucovorin, and fluorouracil, 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 18 to 80 years
Conditions the study is for
Colorectal Cancer
What is being tested?
fluorouracil, leucovorin calcium and oxaliplatin
How many people
600 participants
Where
17 sitesFrance
Study dates
Jan 2004to not given
Phase
Phase 2/3
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 proven adenocarcinoma of the colon or rectum
  • Metastatic disease
  • No metastases involving only the bone
  • Inoperable disease (i.e., not suitable for complete surgical resection)
  • Measurable or evaluable disease
  • Measurable disease defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by conventional CT scan OR ≥ 10 mm by spiral CT scan
  • No symptomatic ascites or pleural effusion that has not been evacuated
  • No CNS metastasis

PATIENT CHARACTERISTICS:

  • WHO OR ECOG performance status 0-2
  • Absolute neutrophil count ≥ 1,500/mm^3
  • Platelets ≥ 100,000/mm^3
  • Creatinine < 3 times upper limit of normal (ULN)
  • Alkaline phosphatase < 5 times ULN
  • No peripheral neuropathy ≥ grade 1
  • No total or partial bowel obstruction
  • Not pregnant or nursing
  • Fertile patients must use effective contraception
  • No uncontrolled hypercalcemia
  • No other concurrent or prior malignancy, except adequately treated carcinoma in situ of the uterine cervix or basal or squamous cell carcinoma of the skin or cancer in complete remission for ≥ 5 years
  • No uncontrolled congestive heart failure
  • No angina pectoris
  • No hypertension
  • No arrhythmias
  • No history of significant neurologic or psychiatric disorders
  • No active infection
  • No other serious nonmalignant disease

PRIOR CONCURRENT THERAPY:

  • No prior chemotherapy and/or immunotherapy for metastatic disease
  • Prior adjuvant chemotherapy allowed provided progression-free interval after completion of adjuvant chemotherapy is > 6 months
  • No other concurrent anticancer treatment
  • No participation in another clinical trial with any investigational drug within 30 days prior to randomization
  • No other concurrent investigational treatment
  • No concurrent radiotherapy
  • No concurrent cold cap for prevention of alopecia or iced mouth rinses for prevention of stomatitis

Trial locations and contacts

17 sites in 1 country.

17 sites in 1 country

France17 sites

  • Institut Sainte Catherine

    Avignon, 84082

  • Hopital Duffaut

    Avignon, 84902

  • Infirmerie Protestante

    Caluire-et-Cuire, 69300

  • Hopital Drevon

    Dijon, 21000

  • Centre Hospitalier de Dreux

    Dreux, 28100

  • Hopital Louis Pasteur - Le Coudray

    Le Coudray, 28630

  • Clinique Victor Hugo

    Le Mans, F-72000

  • Hopital Robert Boulin

    Libourne, 33500

  • Clinique Saint Jean

    Lyon, 69008

  • Intercommunal Hospital

    Montfermeil, 93370

  • Hopital Europeen Georges Pompidou

    Paris, 75015

  • Hopital Saint Antoine

    Paris, 75571

  • Hopital Tenon

    Paris, 75970

  • Polyclinique De Courlancy

    Reims, F-51100

  • C.H. Senlis

    Senlis, 60309

  • Clinique des Jockeys

    Senlis, 60309

  • Centre Medico-Chirurgical Foch

    Suresnes, 92151

Other trials in France

About this study

Official title: Phase II-III Study of an Optimized LV-5FU-Oxaliplatin Strategy in Metastatic Colorectal Cancer. Optimox2 Study. C02-2

RATIONALE: Drugs used in chemotherapy, such as oxaliplatin, leucovorin, and fluorouracil, 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 which combination chemotherapy regimen is more effective in treating colorectal cancer.

PURPOSE: This randomized phase II/III trial is studying two combination chemotherapy regimens to compare how well they work in treating patients with metastatic colorectal cancer that cannot be removed by surgery.

Read the detailed description

OBJECTIVES:

Primary

  • Compare progression-free survival of patients with inoperable metastatic colorectal cancer treated with oxaliplatin, leucovorin calcium, and fluorouracil with vs without maintenance leucovorin calcium and fluorouracil.
  • Demonstrate that time of disease control (TDC) can be increased by 15% at 9 months and that maintenance therapy can be avoided.

Secondary

  • Compare the overall survival and response rate in patients treated with these regimens.
  • Compare the salvage surgery rate in patients treated with these regimens.
  • Compare the tolerability of these regimens in these patients.
  • Compare the quality of life in patients treated with these regimens.
  • Compare the duration of chemotherapy-free intervals in patients treated with these regimens.
  • Compare the pharmacoeconomy and pharmacogenetics of these regimens in these patients.

OUTLINE: This is a randomized, controlled, open-label, multicenter study. Patients are stratified according to participating center, performance status (0-1 vs 2), number of metastatic sites (1 vs > 1), age (18-50 years vs 51-75 years vs 76-80 years), adjuvant chemotherapy, and baseline alkaline phosphatase (≤ 3 times upper limit of normal [ULN] vs > 3 times ULN). Patients are randomized to 1 of 2 treatment arms.

Arm I

  • FOLFOX chemotherapy: Patients receive oxaliplatin IV over 2 hours and leucovorin calcium IV over 2 hours on day 1 and fluorouracil IV continuously over 46 hours on days 1 and 2. Treatment repeats every 14 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients then proceed to maintenance chemotherapy.
  • Maintenance chemotherapy: Patients receive leucovorin calcium IV over 2 hours on day 1 and fluorouracil IV continuously over 46 hours on days 1 and 2. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.

Patients with disease progression on maintenance chemotherapy receive 6 additional courses of FOLFOX as above. Patients with continued disease progression while receiving the additional courses of FOLFOX proceed to irinotecan-based chemotherapy off study.

Arm II

  • FOLFOX chemotherapy: Patients receive 6 courses of FOLFOX as in arm I. Patients with disease progression on FOLFOX receive 6 additional courses of FOLFOX. Patients with continued disease progression while receiving the additional courses of FOLFOX proceed to irinotecan-based chemotherapy off study.

In both arms, patients with stable or responding disease may undergo surgical resection after completion of the initial 6 courses of FOLFOX.

Quality of life is assessed at baseline, after courses 4 and 6, and then every 2-3 months thereafter.

After completion of study treatment, patients are followed at 1 month and then every 3 months thereafter.

PROJECTED ACCRUAL: A total of 600 patients will be accrued for this study.

Keywords
recurrent rectal cancer, stage IV rectal cancer, recurrent colon cancer, stage IV colon cancer, adenocarcinoma of the colon, adenocarcinoma of the rectum
Medical subject headings
Colorectal Neoplasms, Rectal Neoplasms, Colonic 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. Overall survival

  2. Time to disease control

  3. Response as measured by RECIST criteria

  4. Toxicity

  5. Quality of life as assessed by EUROQOL- 5 Dimensional Instrument or Functional Assessment of Cancer Therapy-Neurotoxicity module version 4.0 at baseline and periodically during study treatment

  6. Pharmaco-economic evaluation

Timeline

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

  1. First posted11 Jan 2006 (estimated)
  2. Study startJan 2004

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 2/3
Primary purpose
Treatment
Allocation
Randomised
Masking
None (open label)
Enrolment
600 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00274872
Sponsor's protocol ID
CDR0000453890
Other IDs
GERCOR-OPTIMOX2, GERCOR-OPTIMOX2-2003, GERCOR-OPTIMOX2-C02-2, EU-20566, SANOFI-GERCOR-OPTIMOX2
Status last verified
May 2007
First submitted
10 Jan 2006
Last updated
1 Feb 2010
Results posted
No

Publications

  • Chibaudel B, Maindrault-Goebel F, Lledo G, Mineur L, Andre T, Bennamoun M, Mabro M, Artru P, Carola E, Flesch M, Dupuis O, Colin P, Larsen AK, Afchain P, Tournigand C, Louvet C, de Gramont A. Can chemotherapy be discontinued in unresectable metastatic colorectal cancer? The GERCOR OPTIMOX2 Study. J Clin Oncol. 2009 Dec 1;27(34):5727-33. doi: 10.1200/JCO.2009.23.4344. Epub 2009 Sep 28.

    PubMed 19786657

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing fluorouracil, leucovorin calcium and oxaliplatin in people with Colorectal Cancer, run by GERCOR - Multidisciplinary Oncology Cooperative Group at 17 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 1 Feb 2010. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 17 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 combined 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.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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?

Overall survival. The study lists 6 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 NCT00274872, 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 1 Feb 2010.

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