A PHASE II Study of GM-CSF As Pre- And Post-operative Adjuvant Therapy For Stage II And III Colon Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Proportion of patients with a change in tumor-associated macrophage VEGF expression
研究概览
简要总结
RATIONALE: Colony-stimulating factors, such as GM-CSF, may increase the number of immune cells found in bone marrow or peripheral blood and may help the immune system recover from the side effects of chemotherapy or kill tumor cells. Drugs used in chemotherapy, such as fluorouracil, leucovorin, and oxaliplatin, 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) may kill more tumor cells. Giving combination chemotherapy after surgery may kill any remaining tumor cells. Sometimes, after surgery, the tumor may not need additional treatment until it progresses. In this case, observation may be sufficient.
PURPOSE: This phase II trial is studying how well GM-CSF and combination chemotherapy work in treating patients who are undergoing surgery for stage II or stage III colon cancer.
详细描述
OBJECTIVES:
Primary
- Determine the safety of neoadjuvant and adjuvant sargramostim (GM-CSF) and adjuvant chemotherapy in patients with resectable stage II or III colon cancer.
- Determine the efficacy, in terms of enhanced tumor-associated macrophage response, of this regimen in these patients.
Secondary
- Determine overall survival and time to progression in patients treated with this regimen.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed adenocarcinoma of the colon
- •Stage II or III disease
- •No carcinoma in situ
- •No perforated or obstructed tumors
- •No dual primary lesions by colonoscopy or barium enema
- •Resectable disease
- •Distal and proximal bowel end must be > 5 cm from tumor
- •Tumor must not extend below peritoneal reflection
- •No distant intra-abdominal metastases (even if resected)
- •No rectal cancer
- •No tumors that require opening of the pelvic peritoneum to define the extent of disease
- •PATIENT CHARACTERISTICS:
- •Performance status
- •Life expectancy
- •Not specified
- •Hematopoietic
- •WBC ≥ 3,000/mm^3
- •Platelet count ≥ 100,000/mm^3
- •Bilirubin ≤ 2.0 mg/dL
- •Creatinine ≤ 2.0 mg/dL
- •Cardiovascular
- •No symptomatic congestive heart failure
- •No unstable angina pectoris
- •No uncontrolled cardiac arrhythmia
- •Immunologic
- •No ongoing or active infection
- •No allergy to yeast or yeast-based products
- •No allergy to sargramostim (GM-CSF)
- •No allergy to fluorouracil
- •No allergy to leucovorin calcium
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •No history of Crohn's disease
- •No history of ulcerative colitis
- •No other malignancy within the past 3 years except superficial squamous cell or basal cell skin cancer or carcinoma in situ of the cervix
- •No psychiatric illness or social situation that would preclude study compliance
- •No other uncontrolled illness
- •PRIOR CONCURRENT THERAPY:
- •Chemotherapy
- •No prior chemotherapy, including fluorouracil, for colon cancer
- •No other concurrent chemotherapy
- •Radiotherapy
- •No prior radiotherapy for colon cancer
- •No concurrent radiotherapy
- •No other prior therapy for colon cancer
- •No concurrent immunosuppressant therapy
- •No other concurrent investigational agents
- •No other concurrent anticancer therapy
排除标准
- 未提供
结局指标
主要结局
Proportion of patients with a change in tumor-associated macrophage VEGF expression
次要结局
- Disease-free and overall survival