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Colorectal CancerPhase 2NCT00936832

Sunitinib Malate and Combination Chemotherapy as Front-Line Therapy in Treating Patients With Metastatic Rectal Cancer That Cannot Be Removed by Surgery

A Phase 2 study testing FOLFIRI regimen, fluorouracil and irinotecan hydrochloride in people with Colorectal Cancer and Metastatic Cancer, run by Federation Francophone de Cancerologie Digestive at 1 site in France.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

RATIONALE: Sunitinib malate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Drugs used in chemotherapy, such as irinotecan hydrochloride, leucovorin calcium, and fluorouracil, work in different ways to stop the growth of tumor cells… Read more about this study

Who is it for?
Ages 18 to 120 years
Conditions the study is for
Colorectal Cancer, Metastatic Cancer
What is being tested?
FOLFIRI regimen, fluorouracil and irinotecan hydrochloride
How many people
0 participants
Where
1 siteFrance
Study dates
Apr 2009to 24 Mar 2010
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 120 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

DISEASE CHARACTERISTICS:

  • Histologically confirmed adenocarcinoma of the rectum
  • Lower pole of the tumor < 12 cm from the anal margin
  • Synchronous metastases of the liver and/or lung
  • Unresectable or resectability uncertain according to the decision of a local multidisciplinary consultation
  • Lesions measurable in 1 dimension by RECIST criteria (metastases and primary rectal cancer)
  • No rectal obstruction requiring surgery or the emergency fitting of a prosthesis
  • No CNS metastases

PATIENT CHARACTERISTICS:

  • WHO performance status 0-2
  • ANC ≥ 1,500/mm^3
  • Platelet count ≥ 100,000/mm^3
  • Creatinine clearance ≥ 60 mL/min
  • Hemoglobin ≥ 10 g/dL (transfusions allowed)
  • FEV ≥ 50%
  • QT interval ≤ 450 ms (in men) or ≤ 470 ms (in women)
  • Total bilirubin ≤ 1.5 times upper limit of normal
  • Serum albumin ≥ 25 g/L
  • Not pregnant or nursing
  • Fertile patients must use effective contraception
  • No history of another cancer except for nonmelanoma skin cancer or curatively treated carcinoma in situ of the cervix
  • History of other cancers allowed provided the patient has been disease-free > 3 years
  • None of the following:
  • Congestive heart failure or coronary heart disease
  • Myocardial infarction within the past year
  • Uncontrolled hypertension (systolic BP > 160 mm Hg or diastolic BP > 100 mm Hg) despite optimal medical management
  • No active severe rectal bleeding
  • No liver failure
  • No known Gilbert syndrome
  • No severe uncontrolled infection
  • No chronic diarrhea, malabsorption syndrome, or intestinal obstruction/subocclusion
  • No severe uncontrolled pain (visual analogue scale 5/10) with morphine treatment
  • No other medical, psychological, or social condition that, in the investigator's opinion, could affect the patient's compliance with study treatment
  • No hypersensitivity to any component of study treatment

PRIOR CONCURRENT THERAPY:

  • See Patient Characteristics
  • No prior radiotherapy to the pelvis
  • More than 4 weeks since prior experimental therapy
  • More than 7 days since prior CYP3A4 inhibitor before the administration of sunitinib malate
  • More than 12 days since prior CYP3A4 inducer
  • No concurrent participation in another clinical study
  • No other concurrent anticancer therapy

Trial locations and contacts

1 site in 1 country.

France1 site

  • Hopital Ambroise Pare

    Boulogne-Billancourt, 92100

Other trials in France

About this study

Official title: Front-line Combination Therapy of Sunitinib Malate Plus Chemotherapy With Leucovorin/5-Fluorouracil and Irinotecan (FOLFIRI) for Rectal Cancer Patients With Synchronous Non-Resectable Metastases: A Phase II Non Controlled Study. (SUREMETS)

RATIONALE: Sunitinib malate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Drugs used in chemotherapy, such as irinotecan hydrochloride, leucovorin calcium, 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) together with sunitinib malate may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving sunitinib malate together with combination chemotherapy works as front-line therapy in treating patients with metastatic rectal cancer that cannot be removed by surgery.

Read the detailed description

OBJECTIVES:

Primary

  • Evaluation of the efficacy of front-line treatment with sunitinib malate and FOLFIRI chemotherapy at 3 months in patients with rectal cancer and synchronous metastases deemed unresectable in a multidisciplinary consultation.

Secondary

  • Evaluate the rate of resection of secondary metastases and rectal cancer, rate of R0 resection of metastases and rectal cancer, and the rate of complete response after resection.
  • Evaluate the rate of local failure (progression of rectal cancer).
  • Evaluate the rate of local complications.
  • Evaluate disease-free survival.
  • Evaluate progression-free survival, metastatic progression-free survival, and local progression-free survival.
  • Evaluate symptom-free survival.
  • Evaluate overall survival.
  • Evaluate quality of life, specifically fatigue and global health score (EORTC QLQ-C30).
  • Evaluate the tolerance to treatment.
  • Conduct translational research, in particular, pharmacokinetic studies of plasma and rectal tumor biopsies, and histological and molecular studies.

OUTLINE: Patients receive simplified FOLFIRI chemotherapy comprising irinotecan hydrochloride IV over 90 minutes, leucovorin calcium IV over 2 hours, and fluorouracil IV over 46 hours on days 1, 15, and 29. Patients also receive oral sunitinib malate once daily on days 1-28. Treatment repeats every 6 weeks in the absence of disease progression or unacceptable toxicity.

Patients may undergo surgical resection and/or local radiotherapy if the tumor regresses. After resection or radiotherapy, patients may undergo up to 4 more courses of study treatment.

Biopsies of the tumor and healthy mucosa are collected for translational research at baseline. Blood samples are collected for pharmacodynamic and pharmacogenetic studies at baseline and at week 6. Patients also complete a quality-of-life questionnaire (EORTC QLQ-C30) at baseline and periodically thereafter.

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

Being tested
FOLFIRI regimen, fluorouracil, irinotecan hydrochloride, leucovorin calcium, sunitinib malate
Keywords
stage IV rectal cancer, adenocarcinoma of the rectum, liver metastases, lung metastases
Medical subject headings
Colorectal Neoplasms, Neoplasm Metastasis, 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. Response rate at 3 months as assessed by RECIST criteria

Secondary outcomes (13)

  1. Rate of complete response after resection

  2. Rate of R0 resection of metastases

  3. Rate of local failure

  4. Rate of local complications

  5. Metastatic progression-free survival

  6. Local progression-free survival

  7. Disease-free survival

  8. Symptom-free survival

  9. Overall survival

  10. Quality of life, specifically fatigue and global health score (EORTC QLQ-C30)

  11. Time to deterioration of the final score for overall health and fatigue

  12. Tolerance and incidence of side effects as assessed by NCI CTCAE v2

  13. Translational research including pharmacodynamic studies of plasma and rectal tumor biopsies and histological and molecular studies

Timeline

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

  1. First posted10 Jul 2009 (estimated)
  2. Study startApr 2009
  3. Primary completion24 Mar 2010
  4. Study completion24 Mar 2010

Why it stopped: because the sunitinib showed futility in anotehr trial

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
Non-randomised
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00936832
Sponsor's protocol ID
CDR0000637832
Other IDs
FFCD-0801, EUDRACT-2008-005959-19, EU-20918
Status last verified
Jul 2009
First submitted
8 Jul 2009
Last updated
30 Aug 2022
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 and Metastatic 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: withdrawn, as of the sponsor's last update on 30 Aug 2022. 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 was withdrawn before enrolling participants, so there are no results.

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?

Response rate at 3 months as assessed by RECIST criteria. 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 NCT00936832.

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 30 Aug 2022.

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