EUCTR2006-003158-12-NL进行中（未招募）不适用
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
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 790
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 surgery, radiation, and/or systemic therapy (chemotherapy or biological anticancer therapy), and (ii) with no more than 1 prior radiation regimen for primary HNC tumor, and (iii) with no prior systemic therapy (chemotherapy or biological anticancer therapy) for metastatic disease; OR
- •newly diagnosed distant metastatic disease.
- •[2] Prior radiation therapy allowed to <25% of the bone marrow (Cristy and Eckerman 1987). Prior radiation to the whole pelvis is not allowed. Prior radiotherapy for palliative treatment must be completed at least 4 weeks before study enrollment. Patients must have recovered from the acute toxic effects of the treatment 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) =60 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
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