EUCTR2015-000333-71-IT进行中（未招募）1 期
First-line FOLFOX-4 plus panitumumab followed by 5-FU/LV plus panitumumab or single-agent panitumumab as maintenance therapy in patients with RAS wild-type, metastatic colorectal cancer: the VALENTINO study - Valentino
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 224
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. Written informed consent prior to performance of any study procedure;
- •2. Age =18 years;
- •3. ECOG Performance Status 0-1;
- •4. Life expectancy of at least 12 weeks in the opinion of the Investigator;
- •5. Histologically or cytologically confirmed adenocarcinoma of the colon or rectum, with RAS wild-type status;
- •6. Metastatic unresectable colorectal cancer not previously treated with standard chemotherapy for advanced or metastatic disease;
- •7. Measurable or non-measurable metastatic lesion(s), as defined by RECIST version 1.1;
- •8. Laboratory requirements:
- •- Neutrophils ¿ 1.5 x 109/L, Platelets ¿100 x 109/L, and Haemoglobin ¿10g/dL
- •- Total bilirubin ¿1.5 time the upper-normal limits (UNL) of the Institutional normal values; ASAT (SGOT) and/or ALAT (SGPT) ¿2.5 x UNL, or ¿5 x UNL in case of liver metastases; alkaline phosphatase ¿ 2.5 x UNL, ¿ 5 x UNL in case of liver metastases, ¿10 x UNL in case of bone metastases; LDH <1500 U/L
- •- Creatinine clearance (calculated according to Cockroft and Gault) > 60 mL/min or serum creatinine ¿1.5 x upper limit of normal (UNL);
- •9. Patients must be accessible for treatment and follow up. Patients registered on this trial must be treated and followed at the participating center.
- •10. Archival tumor tissue is required for exploratory research at enrolment.
- •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 112
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 112
排除标准
- •Exclude a patient from this study if any of the following conditions are observed:
- •1. Has a serious illness or medical condition(s) including, but not limited to the following:
- •a. Other concurrently active malignancies excluding malignancies that are disease free for more than 5 years or carcinoma-in-situ deemed cured by adequate treatment.
- •b. Known brain metastasis or leptomeningeal metastasis.
- •c. Active infection (ie, body temperature =38°C due to infection).
- •d. Ascites, pleural effusion or pericardial fluid requiring drainage in last 4 weeks.
- •e. Intestinal obstruction, pulmonary fibrosis or interstitial pneumonitis, renal failure, liver failure, or cerebrovascular disorder.
- •f. Uncontrolled diabetes.
- •g. Myocardial infarction within the last 12 months, severe/unstable angina, symptomatic congestive heart failure New York Heart Association (NYHA) class III or IV
- •h. Gastrointestinal hemorrhage.
- •i. Known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)-related illness, or hepatitis B or C.
- •j. Autoimmune disorders or history of organ transplantation that require immunosuppressive therapy.
- •k. Psychiatric disease that may increase the risk associated with study participation or study drug administration, or may interfere with the interpretation of study results.
- •2. Patients who had received adjuvant oxaliplatin-based chemotherapy and had recurrence during treatment or within 12 months from its completion are excluded. Patients who had received adjuvant fluoropyrimidine mono-therapy and had recurrence during treatment or within 6 months from its completion are excluded.
- •3. Disease that is deemed potentially resectable after conversion chemotherapy is excluded. In particular, patients must be deemed unresectable by a multidisciplinary team, even when foreseeing a response to treatment. In case of liver metastases, the concept of resectability must take into account both the aim of oncological radicality (R0 resection) and remanent liver function considerations.
- •4. Treatment with any of the following within the specified time frame prior to study drug administration:
- •a. Major surgery within prior 4 weeks (the surgical incision should be fully healed prior to study drug administration).
- •b. Any anticancer therapy or investigational agent within prior 4 weeks
- •c. Extended field radiation within prior 4 weeks or limited field radiation within prior 2 weeks.
- •5. Has unresolved toxicity of greater than or equal to CTCAE Grade 2 attributed to any prior therapies (excluding anemia, alopecia, skin pigmentation). In particular, patients with platinum induced neurotoxicity greater than or equal CTCAE Grade 2 should be excluded.
- •6. Is a pregnant or lactating female, or is planning to become pregnant during treatment and within 2 months after the end of treatment with panitumumab. Women of child-bearing potential with either positive or no pregnancy test at baseline. Women of child-bearing potential or sexually active men not willing to use contraception during study and for at least 2 months after end of treatment with panitumumab. Postmenopausal women must have been amenorrheic for at least 12 months to be considered of non-child bearing potential.
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