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

• Status: Completed
• Trial end date: 2013-12-01
• Target enrollment: 0
• Participant gender: All

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 cancer.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Federation Francophone de Cancerologie Digestive
• Treatments: Bevacizumab; Calcium; Fluorouracil; Irinotecan; Leucovorin; Levoleucovorin

Criteria

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