G-CSF in Preventing Neutropenia During First-Line Treatment With Chemotherapy and Bevacizumab in Patients With Metastatic Colorectal Cancer

Plain-language summary

This study looks at whether filgrastim (G-CSF) can prevent neutropenia (a drop in immune cells) during chemotherapy and bevacizumab treatment in patients with metastatic colorectal cancer. People with the homozygous UGT1A1*28 (7/7) genotype and measurable disease could take part. The study was carried out in Phase 2 and has been completed.

The summary above is a plain-language rendering of the official record. The original English title is shown for reference.

Trial details

Phase

Phase 2

Status

Completed

Sponsor

Federation Francophone de Cancerologie Digestive

Intervention

bevacizumab, filgrastim, fluorouracil, irinotecan hydrochloride, leucovorin calcium

Start date

11/1/2007

Estimated completion

12/1/2013

Related genes

Eligibility criteria

Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.

DISEASE CHARACTERISTICS:

Inclusion criteria:

* 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

Exclusion criteria:

* Original tumor not removed
* CNS metastases
* Secondary localized cerebral tumors

PATIENT CHARACTERISTICS:

Inclusion criteria:

* WHO performance status 0-2
* 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

Exclusion criteria:

* Progressive gastroduodenal ulcer, prior hemorrhagic ulcer, or perforation in the past 6 months
* Enteropathy or chronic diarrhea
* 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:

Inclusion criteria:

* At least 2 weeks since prior radiotherapy

Exclusion criteria:

* 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