Oseltamivir in Platinum Refractory Ovarian Cancer: Mathematical Modelling Integration for Systemic Therapy (PROMMIS)
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 92
- 试验地点
- 2
研究概览
简要总结
Ovarian cancer is the third most common cancer in Indian females. Population-based cancer registry in India shows that almost 60-
70% of patients with ovarian cancer in India present with locally advanced disease with a 5-year survival of only 25%. Once ovarian
cancer becomes resistant to platinum-based chemotherapy, survival is usually less than a year.
Newer targeted therapies have changed current treatment standards for ovarian cancer in the developed world. Still, they are
inaccessible to most patients in low and middle-income countries (LMICs) because of the cost.
There is an unmet need to develop cost-effective, indigenous, innovative solutions to improve the survival of our cancer patients that
are accessible and affordable in LMICs.
Our collaborators at the Translational Health Sciences and Technology Institute (THSTI), India, have used publically available data on
ovarian cancer cells’ metabolic features to develop a mathematical model to predict possible drugs (approved for other indications)
with anti-cancer properties. Oseltamivir is one such option predicted by their model, and it has been validated in the lab for
platinum-resistant ovarian cancer cells by our collaborators at the Indian Institute of Science (IISc), India.
Oseltamivir is a very low-cost drug that has already been tested for safety in humans and approved for Influenza. We now want to
conduct a phase II single-arm study to test whether combining it with regular chemotherapy drugs used in platinum-resistant
ovarian cancer patients has the potential to improve their response to chemotherapy.
If our study is positive, we will conduct a larger trial to confirm our findings. We will also use the same approach to develop models
and find new low-cost options for other cancers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- Female
入选标准
- •Be willing and able to provide written informed consent for the trial, with a cytopathological or histopathological proven Epithelial Ovarian cancer, have recurrent or metastatic or unresectable disease not amenable to curative intent treatment, Have received and progressed on at least 1 line of anti-cancer treatment in a palliative setting and have either exhausted the standard of care treatment options in second line and beyond, or are unable to afford them, Eastern Cooperative Oncology Group (ECOG) Performance status of 0 to 2, Demonstrate adequate organ function.
- •In case of reproductive age group females, the last menstrual period is to be documented, and a urine pregnancy test is to be done to rule out pregnancy, if the uterus and ovaries are intact.
排除标准
- •Patients with more than one active malignancy or a history of other invasive cancer within the last 5 years, Has an active infection requiring systemic therapy, Has a clinically significant co-morbid condition that might preclude a patient from receiving the intervention treatment, including but not limited to significant cardio-vascular disease, such as history of myocardial infarction, acute coronary syndrome or coronary angioplasty, stenting, bypass grafting within the last 6 months. Congestive heart failure, New York Heart Association Class II-IV, or history of CHF, NYHA class III or IV, Respiratory illness like Chronic Obstructive airway disease or Interstitial lung disease , uncontrolled diabetes mellitus, uncontrolled hypertension, residual grade II or more toxicity per National Cancer Institute.
- •Common Terminology Criteria for Adverse Events v6.0, grade II or more peripheral neuropathy from previous treatments, etc., HIV positive patients not on antiretroviral therapy, Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial, Has a known hypersensitivity to the components of the study therapy or its analogues, Is pregnant or lactating, unless willing to go for medical termination of pregnancy and stop lactation respectively.
研究者
Babita Kataria
National Cancer Institute campus, All India Institute of Medical Sciences, New Delhi