EUCTR2007-006283-30-IT进行中（未招募）不适用
A RANDOMIZED, PHASE 2 STUDY OF FOLFOX OR FOLFIRI WITH AG-013736OR BEVACIZUMAB IN PATIENTS WITH METASTATIC COLORECTALCANCER AFTER FAILURE OF AN IRINOTECAN OR OXALIPLATINCONTAININGFIRST-LINE REGIMEN - ND
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- PFIZER
- 入组人数
- 176
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Histologically-documented metastatic CRC plus any one of the following:
- •Failure of one prior irinotecan- or oxaliplatin-containing regimen documented with radiographic evidence of disease progression as defined by RECIST criteria and
- •documented with 2 sets of CT/MRI scans during irinotecan or oxaliplatin therapy or within 6 months after the last dose of the irinotecan- or oxaliplatin-containing
- •regimen (patients with prior adjuvant chemotherapy or radiation therapy are eligible);
- •Intolerance to prior oxaliplatin therapy, defined as occurrence of Grade 3 or 4 neurotoxicity that is persistent between cycles.
- •2. Adequate organ function, as defined by the following criteria:
- •Absolute neutrophil count (ANC) >/= 1500 cells/mm3
- •Platelets >/=100,000 cells/mm3
- •Hemoglobin >/=9.0 g/dL
- •Total serum bilirubin AST and ALT abnormalities are due to underlying malignancy
- •Serum creatinine Urinary protein <1+ by urine dipstick. If dipstick is >/=1+ then a 24-hour urine collection should be done and the patient may enter only if urinary protein is
- •<2 grams per 24 hours
- •3. Measurable disease by RECIST. Measurable diseases that have been previously radiated
- •will not be considered target lesions unless an increase in size has been observed following completion of radiation therapy.
- •4. Male or female, >/=18 years of age
- •5. Life expectancy >/=12 weeks
- •6. ECOG performance status 0 or 1
- •7. Resolution of all acute toxic effects of prior radiotherapy (except for alopecia), or
- •surgical procedures to NCI CTCAE Grade elective surgery, study treatment should not be administered until surgical incision is
- •fully healed
- •8. No evidence of preexisting uncontrolled hypertension as documented by 2 baseline blood
- •pressure readings taken at least 1 hour apart. The baseline systolic blood pressure
- •readings must be be are eligible.
- •9. Women of childbearing potential must have a negative serum or urine pregnancy test
- •within 3 days prior to treatment.
- •10. Signed and dated informed consent document indicating that the patient (or legally
- •acceptable representative) has been informed of all pertinent aspects of the trial before
- •enrollment.
- •11. Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests,
- •and other study procedures, including completion of PRO measures.
- •12. Eligible to receive FOLFIRI or FOLFOX in combination with bevacizumab
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Prior treatment of metastatic CRC with more than 1 systemic chemotherapy regimen for
- •metastatic disease. Patients who participated in study A4061020 are not eligible to
- •participate in this study.
- •2. Prior irradiation to >/=25% of the bone marrow (whole pelvis =25%; a patient with prior
- •whole pelvis irradiation is ineligible).
- •3. Pleural effusion or ascites that causes >/= Grade 2 dyspnea.
- •4. Current use or anticipated need for food or drugs that are known cytochrome P450 (CYP)
- •3A4 inhibitors (i.e., grapefruit juice, verapamil, ketoconazole, itraconazole,
- •erythromycin, clarithromycin, indinavir, saquinavir, ritonavir, nelfinavir, lopinavir, and
- •delavirdine) during the course of the study
- •5. Current use or anticipated need for drugs that are known CYP3A4 or CYP1A2 inducers
- •(i.e., carbamazepine, dexamethasone, felbamate, omeprazole, phenobarbital, phenytoin,
- •primidone, rifabutin, rifampin, and St John's wort) during the course of study (Note: the
- •short-term use of dexamethasone as a premedication for chemotherapy is not an
- •exclusion criterion)
- •6. History of hemoptysis > œ tsp of bright red blood in one day within past 1 week.
- •7. Patients with active seizure disorder or brain metastases
- •8. Gastrointestinal abnormalities including:
- •inability to take oral medication
- •requirement for intravenous alimentation
- •prior surgical procedures affecting absorption including total gastric resection
- •treatment for active peptic ulcer disease in the past 6 months
- •active gastrointestinal bleeding, unrelated to cancer, as evidenced by hematemesis,
- •hematochezia or melena in the past 3 months without evidence of resolution
- •documented by endoscopy or colonoscopy
- •malabsorption syndromes
- •9. History of any second malignancy except those patients treated with curative intent for
- •skin cancer (other than melanoma) or in situ breast or cervical cancer, or those treated
- •with curative intent for any other cancer with no evidence of disease for 5 years.
- •10. Major surgical procedure, open biopsy, or significant traumatic injury within 4 weeks of
- •treatment. (Also excluded are patient with fine needle aspirations within 7 days of
- •treatment) Note: Insertion of a vascular access device is not considered major or minor
- •11. Dementia or significantly altered mental status that would prohibit the understanding or
- •rendering of informed consent and compliance with the requirements of this protocol.
- •12. Any of the following within the 12 months prior to study drug administration: myocardial
- •infarction, severe/unstable angina, coronary/peripheral artery bypass graft, symptomatic
- •congestive heart failure, cerebrovascular accident or transient ischemic attack, deep vein
- •thrombosis or pulmonary embolism.
- •13. Known dihydropyridine dehydrogenase deficiency.
- •14. History of hypersensitivity to 5-FU or LV.
- •15. Known human immunodeficiency virus (HIV) seropositivity or acquired
- •immunodeficiency syndrome (AIDS)-related illness.
- •16. Serious active infection (viral, fungal, bacterial). Infection requiring parenteral
- •antibiotics at time of enrollment will disqualify the patient.
研究者
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