A Randomized Phase 3 Study of Pemetrexed in Combination with Cisplatin Versus Cisplatin Monotherapy in Patients with Recurrent or Metastatic Head and Neck Cancer - NA

Eli Lilly and Company limited0 个研究点目标入组 790 人开始时间: 2007年6月15日最近更新: 2014年10月7日

试验速览

阶段: 不适用
状态: 进行中（未招募）
发起方: Eli Lilly and Company limited
入组人数: 790

研究概览入排标准研究者记录与标识符相似试验

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] Histologic or cytologic diagnosis of squamous cell HNC, either:
•recurrent disease (locally advanced or metastatic) that is not amenable to local therapy, (i) with at least 6 months since completion of systemic therapy (chemotherapy or biological anticancer therapy), and (ii) with no more than 1 prior multimodal therapy (such as concurrent chemoradiation with or without sequential chemotherapy) for locally advanced HNC tumor, and (iii) with no prior systemic therapy (chemotherapy or biological anticancer therapy) for metastatic disease; OR
•newly diagnosed distant metastatic disease (Stage IVc).
•[2] Prior therapies:
•Radiation therapy must be completed at least 4 weeks before study enrollment. For palliative therapy,prior radiation therapy allowed to <25% of the bone marrow (Cristy and Eckerman 1987) and prior radiation to the whole pelvis is not allowed. Patients must have recovered from the acute toxic effects of the treatment prior to study enrollment.
•Surgery (excluding prior diagnostic biopsy) must be completed at least 4 weeks before study enrollment. Patients must have fully recovered from any acute effects of surgery prior to study enrollment.
•[3] Life expectancy of at least 3 months.
•[4] Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2 (Oken et al. 1982). See Protocol Attachment JMHR.3.
•[5] Disease status may be measurable or nonmeasurable as defined by Response Evaluation Criteria in Solid Tumors (RECIST; Therasse et al. 2000). Positron emission tomography (PET) scans and ultrasounds may not be used for lesion measurements.
•[6] Patient compliance and geographic proximity that allow for adequate follow-up.
•[7] Adequate organ function as defined by the following:
•Bone marrow reserve: absolute neutrophil (segmented and bands) count (ANC) =1.5 x 10e9/L, platelets =100 x 10e9/L, and hemoglobin =9 g/dL.
•Hepatic: bilirubin < or = 1.5 x the upper limit of normal (ULN); alkaline phosphatase (ALP), aspartate aminotransferase (AST), and alanine aminotransferase (ALT) >3.0 x ULN. (ALP, AST, and ALT >5.0 x ULN is acceptable if the liver has tumor involvement.)
•Renal: calculated creatinine clearance (CrCl) = 45 mL/min based on the standard Cockcroft and Gault formula (Cockcroft and Gault 1976). (See Protocol Attachment JMHR.4.)
•[8] Signed informed consent from patient.
•[9] Patients at least 18 years of age.
•[10] For women: Must be surgically sterile, postmenopausal, or compliant with a medically approved contraceptive regimen (for example, intrauterine device [IUD], birth control pills, or barrier device) during and for 6 months after the treatment period; must have a negative serum or urine pregnancy test within 7 days before study enrollment, and must not be breast-feeding.
•For men: Must be surgically sterile or compliant with a contraceptive regimen during and for 6 months after the treatment period.
•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

•[11] Prior systemic therapy (chemotherapy or biological anticancer therapy) for metastatic disease.
•[12] Have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry.
•[13] Serious concomitant systemic disorder (for example active infection or cardiac disease) or psychiatric disorder that, in the opinion of the investigator, would compromise the patient’s ability to complete the study.
•[14] Presence of clinically significant (by physical exam) third-space fluid collections, for example, ascites or pleural effusions that cannot be controlled by drainage or other procedures prior to study entry.
•[15] Second primary malignancy that is clinically detectable at the time of consideration for study enrollment.
•[16] Have had another primary malignancy other than HNC, unless that prior malignancy was treated at least 2 years previously with no evidence of recurrence. Exception: Patients with a history of in situ carcinoma of the cervix, nonmelanoma skin cancer, or low-grade (Gleason score =6) localized prostate cancer will be eligible even if diagnosed and treated less than 2 years previously.
•[17] Nasopharyngeal, paranasal sinus, lip, or salivary gland cancer.
•[18] Have central nervous system (CNS) metastases (unless the patient has completed successful local therapy for CNS metastases and has been off corticosteroids for at least 4 weeks before starting study therapy). Brain imaging is required in symptomatic patients to rule out brain metastases, but is not required in asymptomatic patients.
•[19] Inability to interrupt aspirin or other nonsteroidal anti-inflammatory agents, other than an aspirin dose =1.3 grams per day, for a 5-day period (8-day period for long-acting agents, such as piroxicam).
•[20] Unable or unwilling to take folic acid, vitamin B12, or prophylactic corticosteroids.
•[21] Concurrent administration of any other antitumor therapy.
•[22] Pregnant or breast-feeding.

研究者

发起方

Eli Lilly and Company limited

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