A Phase II Trial of Pharmacological Ascorbate, Gemcitabine, and Nab-Paclitaxel for Metastatic Pancreatic Cancer (PACMAN 2.1)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Overall survival
研究概览
简要总结
This clinical trial adds high-dose ascorbate (vitamin C) to the standard of care regimen for metastatic pancreatic adenocarcinoma (a type of pancreatic cancer). Subjects are randomized between a control group (standard treatment) and an intervention group (pharmacologic ascorbate in addition to the standard treatment).
详细描述
One of the standard treatments for metastatic pancreatic adenocarcinoma is nab-paclitaxel with gemcitabine. This standard therapy administers chemotherapy once per week for three weeks; patients then get a 'rest week' to complete the cycle (1 cycle = 4 weeks).
This study adds 75 grams of ascorbate (vitamin C, sometimes called pharamcological ascorbate because the dose is so high) to standard therapy. The ascorbate is administered intravenously - through a vein in the arm.
Participants in the control group will:
- receive gemcitabine and nab-paclitaxel chemotherapy, which is standard for their cancer.
- undergo imaging which is standard for their cancer and therapy. This can include CT scans, PET scans, and X-rays
Participants in the intervention group will:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
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
- •Pathologic diagnosis (cell samples, biopsy, brushing, surgical sample) of adenocarcinoma of the pancreas. Cancer from the Ampullae of Vater is also eligible. The tissue sample can be from a metastatic location, like a lymph node.
- •Metastatic or node positive disease
- •One cancer site, that did not receive radiation therapy, that is at least 1 cm in size when looking at it by CT scan (CAT scan)
- •Recommended to receive gemcitabine and nab-paclitaxel
- •Failed initial therapy or be ineligible for definitive curative therapy (e.g., surgical excision, radiation therapy)
- •A platelet count of at least 100,000 cells per mL
- •A creatinine level of less than 1 1/2 times the upper limit of normal for the local lab test, or, a creatinine clearance of at least 60 mL/(min*1.73m2)
- •Not pregnant
- •Commit to using birth control during the study (all participants)
排除标准
- •Prior chemotherapy to treat the metastatic disease
- •Other therapy (including radiation) within the past 4 weeks
- •Side effects from prior therapies that are still deemed moderate to severe by a physician
- •Glucose-6-phosphate dehydrogenase (G6PD) deficiency
- •Patients actively receiving insulin or who are currently recommended to receive insulin by a doctor
- •Patients requiring daily finger-stick blood glucose measurements
- •Patients who are on the following drugs and cannot have a substitution (or who decline the substitution):
- •flecainide
- •methadone
- •amphetamines
- •quinidine
- •chlorpropamide
- •An active cancer, other than the pancreatic cancer, that requires treatment.
- •Enrolled in another therapeutic clinical trial
- •Uncontrolled, intercurrent illness
- •HIV positive individuals undergoing therapy due to known drug:drug interaction between antiretroviral drugs and high-dose ascorbate therapy
- •Women who are nursing
研究组 & 干预措施
Ascorbate group
Each cycle is 4 calendar weeks
Gemcitabine: 1000 mg/m2, once weekly for 3 weeks nab-paclitaxel: 125 mg/m2, once weekly for 3 weeks Pharmacological ascorbate: 75 grams, three times weekly for 4 weeks
干预措施: Gemcitabine (Drug)
Ascorbate group
Each cycle is 4 calendar weeks
Gemcitabine: 1000 mg/m2, once weekly for 3 weeks nab-paclitaxel: 125 mg/m2, once weekly for 3 weeks Pharmacological ascorbate: 75 grams, three times weekly for 4 weeks
干预措施: nab-paclitaxel (Drug)
Ascorbate group
Each cycle is 4 calendar weeks
Gemcitabine: 1000 mg/m2, once weekly for 3 weeks nab-paclitaxel: 125 mg/m2, once weekly for 3 weeks Pharmacological ascorbate: 75 grams, three times weekly for 4 weeks
干预措施: Pharmacological ascorbate (Drug)
Control
Each cycle is 4 calendar weeks
Gemcitabine: 1000 mg/m2, once weekly for 3 weeks nab-paclitaxel: 125 mg/m2, once weekly for 3 weeks Each cycle has 1 rest week
干预措施: Gemcitabine (Drug)
Control
Each cycle is 4 calendar weeks
Gemcitabine: 1000 mg/m2, once weekly for 3 weeks nab-paclitaxel: 125 mg/m2, once weekly for 3 weeks Each cycle has 1 rest week
干预措施: nab-paclitaxel (Drug)
结局指标
主要结局
Overall survival
时间窗: Every 2 months for up to 20 years post-treatment
Time, measured in months, from the start of chemotherapy (C1D1) to death from any cause.
Overall Survival
时间窗: Every 2 months until death from any cause, up to approximately 69 months.
Time, measured in months, from the start of chemotherapy (C1D1) to death from any cause or until trial completion.
次要结局
- Tumor Response(Every 2 months for up to 10 years)
- Progression free survival(Every 2 months for up to 10 years)
- Adverse event frequency and categorization(Monthly through 30 days after end of treatment.)
- Progression Free Survival(Every 2 months to date of progression, up to approximately 69 months.)
研究者
John M. Buatti
Professor, Department of Radiation Oncology
University of Iowa