Colorectal CancerPhase 2NCT00541125
G-CSF in Preventing Neutropenia During First-Line Treatment With Chemotherapy and Bevacizumab in Patients With Metastatic Colorectal Cancer
A Phase 2 study testing bevacizumab, filgrastim and fluorouracil in people with Colorectal Cancer, run by Federation Francophone de Cancerologie Digestive.
Trial summary
RATIONALE: G-CSF may prevent or control neutropenia caused by first-line therapy in patients with metastatic colorectal cancer. PURPOSE: This phase II trial is studying how well G-CSF works in preventing neutropenia during first-line treatment with chemotherapy and bevacizumab in patients with metastatic colorectal… Read more about this study
- Who is it for?
- Ages 18 to 74 years
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- bevacizumab, filgrastim and fluorouracil
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Nov 2007to Dec 2013
- 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 74 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically confirmed adenocarcinoma of the colon or rectum
- Metastatic disease
- Not surgically curable
- Homozygous for allele UGT1A1*28, the promoter of the gene coding for UGT1A1 (genotype 7/7)
- Measurable and/or evaluable disease
- WHO performance status 0-2
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- ANC ≥ 1,500/mm^3
- Platelet count ≥ 100,000/mm^3
- Hemoglobin ≥ 9 g/dL
- Creatinine > 1.5 mg/dL
- Total bilirubin ≤ 1.5 times normal
- Alkaline phosphatase ≤ 2.5 times normal (5 times normal if liver involvement)
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients of must use effective contraception
- At least 2 weeks since prior radiotherapy
Who cannot join
- Original tumor not removed
- CNS metastases
- Secondary localized cerebral tumors
- PATIENT CHARACTERISTICS:
- Progressive gastroduodenal ulcer, prior hemorrhagic ulcer, or perforation in the past 6 months
- Enteropathy or chronic diarrhea
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- Chronic inflammatory intestinal disease
- Intestinal obstruction
- Active cardiac disease including any of the following:
- Uncontrolled hypertension
- Myocardial infarction in the past 12 months
- Serious angina
- NYHA class II-IV congestive heart failure
- Severe arrhythmia (even if treated)
- Peripheral vascular disease ≥ grade 2
- Unhealed wound, ulcer, or severe bone fracture
- Bleeding disorder or coagulopathy
- Severe uncontrolled infection or medical condition
- Proteinuria > 500 mg/24 hours
- Other malignancy within the past 5 years except basal cell skin cancer or curatively treated carcinoma in situ of the cervix
- Known dihydropyrimidine dehydrogenase deficiency
- Severe traumatic injury within the past 4 weeks
- PRIOR CONCURRENT THERAPY:
- Prior chemotherapy for metastatic disease except adjuvant chemotherapy completed > 6 months ago
- Prior irinotecan hydrochloride or bevacizumab
- Major surgery or biopsy within the past 4 weeks
- Major surgery planned
- Puncture in the past week
- Chronic aspirin (> 325 mg/day) or NSAIDs
- Concurrent antifungal azoles (e.g., ketoconazole, fluconazole, itraconazole)
- Concurrent phenytoin (as in yellow fever vaccine)
- Concurrent Hypericum perforatum (St. John's wort)
- Oral or parenteral coagulant in the past 10 days and during study therapy
- Warfarin allowed provided INR < 1.5
About this study
Official title: Phase II, Multicenter Study Evaluating G-CSF as Primary Prophylaxis for Neutropenia Associated With First-line Chemotherapy Regimen FOLFIRI and Bevacizumab in Patients With Metastatic Colorectal Cancer Who Are Homozygous for UGT1A1*28 Polymorphism, the Promoter of the Gene Encoding for the Enzyme UGT1A1
RATIONALE: G-CSF may prevent or control neutropenia caused by first-line therapy in patients with metastatic colorectal cancer.
PURPOSE: This phase II trial is studying how well G-CSF works in preventing neutropenia during first-line treatment with chemotherapy and bevacizumab in patients with metastatic colorectal cancer.
Read the detailed description
OBJECTIVES:
Primary
- Determine if primary prophylaxis comprising filgrastim (G-CSF) makes it possible to obtain neutropenia lower than grade 4 or a 30% decrease in fever in patients with metastatic colorectal cancer receiving first-line FOLFIRI and bevacizumab and who are homozygous for allele UGT1A1*28 (genotype 7/7), a promoter of the gene coding for enzyme UGT1A1.
Secondary
- Evaluate the objective response rate at 6 months of treatment with FOLFIRI and bevacizumab according to RECIST criteria.
- Evaluate the toxicity (excluding neutropenia) of FOLFIRI and bevacizumab according to NCI-CTC v. 2.0.
- Determine progression-free and overall survival.
- Determine the time to treatment failure.
OUTLINE: This is a multicenter study.
Patients receive bevacizumab IV over 30-90 minutes, irinotecan hydrochloride IV over 90 minutes, leucovorin calcium IV over 2 hours, and fluorouracil IV over 46 hours on day 1. Patients also receive filgrastim (G-CSF) subcutaneously on days 5-11. Treatment repeats every 2 weeks in the absence of disease progression or unacceptable toxicity.
After completion of study therapy, patients are followed every 2-3 months for up to 5 years.
- Conditions
- Colorectal Cancer
- Being tested
- bevacizumab, filgrastim, fluorouracil, irinotecan hydrochloride, leucovorin calcium
- Keywords
- recurrent colon cancer, stage IV colon cancer, recurrent rectal cancer, stage IV 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.
bevacizumabBiological
filgrastimBiological
fluorouracilDrug
| Study group | Role | What they receive |
|---|---|---|
| FOLFIRI-bévacizumab avec G-CSF en prophylaxie primaire | Other | FOLFIRI-bévacizumab avec G-CSF en prophylaxie primaire Receives: Biological: bevacizumab; Biological: filgrastim; Drug: fluorouracil; Drug: irinotecan hydrochloride; Drug: leucovorin calcium |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of neutropenia grade 4 or fever
Measured: 2013
Toxicities by NCI-CTC v. 2.0
Measured: 2013
Secondary outcomes (5)
Objective response at 6 months by RECIST
Measured: 2013
Tolerance (except neutropenia) by NCI-CTC v. 2.0
Measured: 2013
Progression-free survival
Measured: 2013
Overall survival
Measured: 2013
Time to treatment failure
Measured: 2013
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2007 (estimated)
- Study startNov 2007
- Primary completionSep 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federation Francophone de Cancerologie Digestive
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Thierry Lecomte, MD, Study chair, CHRU de Tours - Hopital Trousseau
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00541125
- Sponsor's protocol ID
- CDR0000564089
- Other IDs
- FFCD-0604, EU-20757, EUDRACT-2007-001772-37
- Status last verified
- May 2016
- First submitted
- 5 Oct 2007
- Last updated
- 30 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II, Multicenter Study Evaluating G-CSF as Primary Prophylaxis for Neutropenia Associated With First-line Chemotherapy Regimen FOLFIRI and Bevacizumab in Patients With Metastatic Colorectal Cancer Who Are Homozygous for UGT1A1*28 Polymorphism, the Promoter of the Gene Encoding for the Enzyme UGT1A1
- ClinicalTrials.gov ID
- NCT00541125
- Acronym / sponsor ID
- CDR0000564089
- Conditions
- Colorectal Cancer
- Keywords
- recurrent colon cancer, stage IV colon cancer, recurrent rectal cancer, stage IV rectal cancer, adenocarcinoma of the colon, adenocarcinoma of the rectum
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Federation Francophone de Cancerologie DigestiveUniversity, hospital or other
- Study start
- Nov 2007
- Primary completion
- Sep 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 8 Oct 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
RATIONALE: G-CSF may prevent or control neutropenia caused by first-line therapy in patients with metastatic colorectal cancer.
PURPOSE: This phase II trial is studying how well G-CSF works in preventing neutropenia during first-line treatment with chemotherapy and bevacizumab in patients with metastatic colorectal cancer.
Detailed description
OBJECTIVES:
Primary
- Determine if primary prophylaxis comprising filgrastim (G-CSF) makes it possible to obtain neutropenia lower than grade 4 or a 30% decrease in fever in patients with metastatic colorectal cancer receiving first-line FOLFIRI and bevacizumab and who are homozygous for allele UGT1A1*28 (genotype 7/7), a promoter of the gene coding for enzyme UGT1A1.
Secondary
- Evaluate the objective response rate at 6 months of treatment with FOLFIRI and bevacizumab according to RECIST criteria.
- Evaluate the toxicity (excluding neutropenia) of FOLFIRI and bevacizumab according to NCI-CTC v. 2.0.
- Determine progression-free and overall survival.
- Determine the time to treatment failure.
OUTLINE: This is a multicenter study.
Patients receive bevacizumab IV over 30-90 minutes, irinotecan hydrochloride IV over 90 minutes, leucovorin calcium IV over 2 hours, and fluorouracil IV over 46 hours on day 1. Patients also receive filgrastim (G-CSF) subcutaneously on days 5-11. Treatment repeats every 2 weeks in the absence of disease progression or unacceptable toxicity.
After completion of study therapy, patients are followed every 2-3 months for up to 5 years.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| FOLFIRI-bévacizumab avec G-CSF en prophylaxie primaire | Other | Biological: bevacizumab, Biological: filgrastim, Drug: fluorouracil, Drug: irinotecan hydrochloride, Drug: leucovorin calciumFOLFIRI-bévacizumab avec G-CSF en prophylaxie primaire |
Who may qualify
- Ages
- 18 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Histologically confirmed adenocarcinoma of the colon or rectum
- Homozygous for allele UGT1A1*28, the promoter of the gene coding for UGT1A1 (genotype 7/7)
- Measurable and/or evaluable disease
- WHO performance status 0-2
- ANC ≥ 1,500/mm^3
Key exclusion criteria (34 listed)
- Original tumor not removed
- CNS metastases
- Secondary localized cerebral tumors
- Progressive gastroduodenal ulcer, prior hemorrhagic ulcer, or perforation in the past 6 months
- Enteropathy or chronic diarrhea
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| bevacizumab | Biological | FOLFIRI-bévacizumab avec G-CSF en prophylaxie primaire |
| filgrastim | Biological | FOLFIRI-bévacizumab avec G-CSF en prophylaxie primaire |
| fluorouracil | Drug | FOLFIRI-bévacizumab avec G-CSF en prophylaxie primaire |
| irinotecan hydrochloride | Drug | FOLFIRI-bévacizumab avec G-CSF en prophylaxie primaire |
| leucovorin calcium | Drug | FOLFIRI-bévacizumab avec G-CSF en prophylaxie primaire |
Primary outcome
Rate of neutropenia grade 4 or fever
Time frame: 2013
Toxicities by NCI-CTC v. 2.0
Time frame: 2013
5 secondary outcomes
Objective response at 6 months by RECIST
Time frame: 2013
Tolerance (except neutropenia) by NCI-CTC v. 2.0
Time frame: 2013
Progression-free survival
Time frame: 2013
Overall survival
Time frame: 2013
Time to treatment failure
Time frame: 2013
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thierry Lecomte, MD study chair
CHRU de Tours - Hopital Trousseau
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing bevacizumab, filgrastim and fluorouracil in people with Colorectal Cancer, run by Federation Francophone de Cancerologie Digestive.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 34 exclusion criteria. 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 30 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
Rate of neutropenia grade 4 or fever (time frame: 2013). 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?
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 Mar 2020.