Phase II Combination of Pemetrexed and Oxaliplatin in Patients With Recurrent Non-Small Cell Lung Cancer After Failure to Platinum Based Adjuvant Chemotherapy
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 1
- 试验地点
- 1
- 主要终点
- Number of Patients Who Responded to Treatment
研究概览
简要总结
The purpose of this study is:
- To find out if the chemotherapy treatment using Pemetrexed (Alimta) and Oxaliplatin (Eloxatin) given together will kill the cancer cells in the patient's body and shrink the size of their tumor. This may allow patients to live longer or decrease the frequency and/or severity of the symptoms caused by the cancer. Pemetrexed has been approved by the Food and Drug Administration (FDA) to treat Lung Cancer. Oxaliplatin has been approved by the FDA for the treatment of Colon Cancer. The combination of these two drugs has been used to treat patients with Non-Small Cell Lung Cancer in Italy but not yet in the USA
Other purposes of this study are:
- To better detail the toxic effects of this chemotherapy combination.
- To determine whether the level of specific gene and/or gene products (genes are genetic material that allows cells to make proteins such as enzymes) are useful to predict if this chemotherapy combination will work or not.
详细描述
Treatment Plan:
This is a non-randomized, two stage design, open-label Phase II trial in newly diagnosed patients with advanced or metastatic NSCLC who have previously received and failed adjuvant platinum-based chemotherapy for early stage, resected NSCLC.
Correlative Studies; Molecular correlative studies (genomic and proteomic) are included in this protocol. Prior to chemotherapy, all patients will undergo a biopsy of the safest and/or most accessible site of tumor in order to obtain tissue for mRNA measurements. Additionally, patients will undergo blood sampling prior to the start of chemotherapy and after 2 and 4 cycles of therapy in order to obtain plasma for the mass spectrometry analysis.
Patients, whose second and/or third specimen cannot be collected for any reason, will remain in the trial, and treatment will continue as outlined in the protocol.
Expected Number of Patients:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •History of completely resected NSCLC and adjuvant/neoadjuvant chemotherapy with platinum-based regimen
- •Histologically/cytologically confirmed recurrence of NSCLC after curative therapy with surgery and adjuvant/neoadjuvant chemotherapy
- •Must have measurable disease according to RECIST criteria
- •ECOG Performance Score of 0-2 determined within 2 weeks prior to enrollment
- •Expected survival > 12 weeks
- •Adequate bone marrow function,as evidenced by:
- •Absolute neutrophil count (ANC) > 1,500/µL
- •Platelet count > 100,000/µL
- •Hemoglobin > 8 g/dL (determined within 2 weeks prior to enrollment)
- •Adequate renal function evidenced by:
- •serum creatinine < 1.5 mg/dL OR
- •calculated creatinine clearance >45 mL/min.
- •Adequate hepatic function evidenced by:
- •Serum total bilirubin < 1.5 mg/dL OR less than the upper limit of normal (ULN)
- •Alkaline phosphatase < 3X the ULN for the reference lab (< 5X the ULN for patients with known hepatic or bony metastases)
- •SGOT/SGPT < 3X the ULN for the reference lab (< 5X the ULN for patients with known hepatic metastases)
- •Must be recovered from both acute and late effects of any prior surgery, radiotherapy, other antineoplastic therapy
- •Signed informed written consent
- •Patients of childbearing potential and their partners must agree to use an effective form of contraception during the study and for 90 days following last dose of study medication
排除标准
- •Patients amenable to a "curative intent" therapeutic approach (re-resection with or without preoperative or postoperative therapy or chemoradiotherapy without surgery are not eligible for this study).
- •An active infection or with fever > 101.00 F within 3 days of first scheduled day of protocol treatment
- •Active CNS metastases. Patients with stable CNS disease, who have undergone radiotherapy (or surgery ± radiotherapy) at least 4 weeks prior to planned first protocol treatment and who have been on stable or decreasing dose of corticosteroids for >2 weeks are eligible
- •Prior malignancy within the past 5 years except for curatively treated basal cell carcinoma of the skin, cervical intra-epithelial neoplasia, or localized prostate cancer with a current PSA of < 1.0 mg/dL on 2 successive evaluations, at least 3 months apart, with most recent evaluation no more than 4 weeks prior to entry.
- •Any diagnosis of NSCLC occurring after 5 years of curative therapy (surgery plus adjuvant chemotherapy) for original NSCLC will be considered a second primary rather than a recurrence and will render patient ineligible for this study. An exception will be if both tumors are considered the same after a direct pathologic comparison if both, sponsor and investigator agree.
- •Patients that at discretion of the PI have a second primary rather than metastasis are not eligible
- •Known hypersensitivity to any of the components of oxaliplatin or pemetrexed.
- •Patients receiving concurrent investigational therapy or who have received investigational therapy within 30 days of the first scheduled day of protocol treatment
- •Patients who received radiotherapy to more than 33% of their bone marrow or received any radiotherapy within 4 weeks of entry
- •Peripheral neuropathy ≥ Grade 2
- •Patients pregnant or lactating
- •Any other medical condition, including mental illness or substance abuse, deemed likely to interfere with patient's ability to sign informed consent, cooperate and participate in the study, or interfere with interpretation of the results.
- •History of allogeneic transplant
- •Known history of HIV or Hepatitis B or C infection. Patients with Hepatitis B carrier status only are eligible.
研究组 & 干预措施
Premetrexed and Oxaliplatin
Patients will be treated with oxaliplatin 120 mg/m^2 i.v. over 2 hours and pemetrexed 500 mg/m^2 i.v. over 10 minutes on Day 1 of a 21day cycle. Cycles of treatment will be repeated every 3 weeks. Folic acid and B12 supplementation is obligatory.
干预措施: Oxaliplatin (Drug)
Premetrexed and Oxaliplatin
Patients will be treated with oxaliplatin 120 mg/m^2 i.v. over 2 hours and pemetrexed 500 mg/m^2 i.v. over 10 minutes on Day 1 of a 21day cycle. Cycles of treatment will be repeated every 3 weeks. Folic acid and B12 supplementation is obligatory.
干预措施: Pemetrexed (Drug)
结局指标
主要结局
Number of Patients Who Responded to Treatment
时间窗: Patient will continue study treatment until death, disease progression, unacceptable toxicity, patient refusal, or treatment delay > 3 weeks.
We planned to determine the Overall Response Rate (ORR = CR+PR) of this regimen according to RECIST Criteria.
次要结局
- Number of Participants Who Experienced Toxicities(Patient will continue study treatment until death, disease progression, unacceptable toxicity, patient refusal, or treatment delay > 3 weeks.)
- Time to Progression (TTP)(Patient will continue study treatment until death, disease progression, unacceptable toxicity, patient refusal, or treatment delay > 3 weeks.)