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Durvalumab and Tremelimumab and Best Supportive Care vs Best Supportive Care in Patients With Advanced Colorectal Cancer

ABSTRACT: The standard or usual treatment for this disease is treatment with drugs and other treatments that may help to make a patient better or may improve their quality of life. This treatment is known as "best supportive care" (BSC). Although patients with best supportive care can feel better for some months, the cancer usually continues to grow.

DISEASE(S): Colorectal Cancer,Colorectal Neoplasms

PROVIDER: 2222712 | ecrin-mdr-crc |

REPOSITORIES: ECRIN MDR

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Cetuximab and Best Supportive Care Compared with Best Supportive Care Alone in Treating Patients with Metastatic Epidermal Growth Factor Receptor-Positive Colorectal Cancer.

Project description:Interventions: This is a randomised, open-label, multicenter study. Patients are stratified according to participating center and ECOG performance status (0 or 1 vs 2). Patients are randomised to 1 of 2 treatment arms. Arm I: Patients receive an initial loading dose of cetuximab (Erbitux) IV over 120 minutes on day 1. Patients continue to receive maintenance infusions of cetuximab IV over 60 minutes weekly. Patients also receive best supportive care, defined as measures designed to provide palliation of symptoms and improve quality of life as much as possible. Arm II: Patients receive best supportive care as in arm I. In both arms, treatment continues in the absence of disease progression or unacceptable toxicity. Quality of life is assessed at baseline, and then at 4, 8, 16, and 24 weeks (or until deterioration to ECOG PS 4 or hospitalisation for end of life care). Patients are followed up every 4 weeks. Primary outcome(s): Compare survival of patients with metastatic epidermal growth factor receptor-positive colorectal cancer treated with cetuximab and best supportive care vs best supportive care alone.[Measured from enrolment] Study Design: Purpose: Treatment; Allocation: Randomised controlled trial; Masking: Open (masking not used);Assignment: Parallel;Type of endpoint: Efficacy

| 2452710 | ecrin-mdr-crc

Cetuximab + Best Supportive Care Compared With Best Supportive Care Alone in Metastatic Epidermal Growth Factor Receptor-Positive Colorectal Cancer

Project description:RATIONALE: Monoclonal antibodies, such as cetuximab, can target tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Best supportive care is the use of drugs and other treatments to improve the quality of life of patients. Combining cetuximab with best supportive care may slow the growth of the tumor and help patients live longer and more comfortably. It is not yet known whether cetuximab combined with best supportive care is more effective than best supportive care alone in treating metastatic epidermal growth factor receptor-positive colorectal cancer. PURPOSE: This randomized phase III trial is studying cetuximab and best supportive care to see how well they work compared to best supportive care alone in treating patients with metastatic epidermal growth factor receptor-positive colorectal cancer.

| 2010537 | ecrin-mdr-crc

Trial of Best Supportive Care and Either Cisplatin or Paclitaxel to Treat Patients With Primary Ovarian Cancer, Primary Peritoneal Cancer or Fallopian Tube Cancer and Inoperable Malignant Bowel Obstruction

Project description:The best way to treat MBO in patients with ovarian cancer has not been studied enough by trials that assess how more than one treatment arm (surgical, chemotherapeutic, supportive care approaches) affects clinical outcomes like resolution of bowel obstruction, survival, and quality of life. To improve patient outcomes, we must assess which patients will do better with palliative surgery, chemotherapy, or best supportive care. This study will gather safety information, and how reasonable it is to give chemotherapy and BSC to patients with advanced ovarian cancer and MBO who are non-surgical candidates. This study will also look into the effects of chemotherapy and BSC on the quality of life and resolution of bowel obstruction, in hopes to perform future studies that lead to the best management of MBO.

| 2086061 | ecrin-mdr-crc

A Study to Estimate Overall Survival in Patients Receiving Best Supportive Care for Treatment-Resistant, Metastatic Colorectal Carcinoma

Project description:The primary objective of this study is to estimate overall survival in patients only receiving best supportive care (BSC) for treatment-resistant, metastatic colorectal carcinoma. The primary efficacy outcome is overall survival, defined as the time from the date of the radiographic scan demonstrating disease progression post available treatments (time of origin, T0) to death from any cause.

| 2240059 | ecrin-mdr-crc

Comparison of Survival Benefit of Panitumumab With Supportive Care to Best Supportive Care Alone in Patients With Metastatic Colorectal Cancer

Project description:The purpose of this study is to evaluate the benefit of panitumumab in addition to best supportive care compared to best supportive care alone in patients with chemorefractory wild-type KRAS (Kirsten rat sarcoma viral oncogene homolog) metastatic colorectal cancer.

| 2111195 | ecrin-mdr-crc

A Phase III Randomized Study of BBI608 and Best Supportive Care versus Placebo and Best Supportive Care in Patients with Pretreated Advanced Colorectal Carcinoma

Project description:Interventions: Group 1: Best supportive care plus BBI608. Best supportive care defined as those measures designed to provide palliation of symptoms and improve quality of life as much as possible. BBI608 will be self-administered by participants at 480mg (6 x 80mg tablets) orally twice daily (960mg total daily dose) in 28 day cycles. Patients may continue to receive protocol therapy as long as they have not experienced any adverse events requiring permanent discontinuation of study medication and are, in the opinion of the investigator, continuing to derive benefit from protocol therapy. Patients will be asked to keep a diary of when they take the capsules and if they miss any doses to monitor adherance. Patients will also be asked to return any tablets which were not taken. Primary outcome(s): Overall survival (death from any cause)[Patient status updates will be sought every 2-4 weeks at clinic visit whilst on treatment and then every 8 weeks until death.] Study Design: Purpose: Treatment; Allocation: Randomised controlled trial

| 2459551 | ecrin-mdr-crc

BBI608 and Best Supportive Care vs Placebo and Best Supportive Care in Pretreated Advanced Colorectal Carcinoma

Project description:The purpose of this study is to find out whether it is better to receive a new drug, BBI608, or better to receive no further treatment for colon or rectal cancer. To do this, half of the patients in this study will get BBI608 and the other half will receive a placebo (a substance that is designed not to do anything).

| 2143054 | ecrin-mdr-crc

A PHASE 3, MULTICENTER, RANDOMIZED, OPEN-LABEL TRIAL TO EVALUATE THE SURVIVAL BENEFIT OF PANITUMUMAB AND BEST SUPPORTIVE CARE, COMPARED TO BEST SUPPORTIVE CARE ALONE, IN SUBJECTS WITH CHEMOREFRACTORY WILD-TYPE KRAS METASTATIC COLORECTAL CANCER

Project description:Interventions: THE SUBJECT ACCRUAL PERIOD IS PLANNED AL APPROXIMATELY 30 MONTHS. SUBJECTS WILL BE FOLLOWED FOR SURVIVAL FOR UP TO 24 MONTHS AFTER THE LAST SUBJECT IS RANDOMIZED IN THE STUDY OR UNTIL APPROXIMATELY 250 DEATHS ARE OBSERVED, WHICHEVER IS LATER. THEREFORE, THE STUDY DURATION WILL BE APPROXIMATELY 54 MONTHS. SUBJECTS WILL BE STRATIFIED ACCORDING TO GEOGRAPHIC REGION (EUROPE VS. ASIA VS. REST OF THE WORLD) AND EASTERN COOPERATIVE ONCOLOGY GROUP (ECOG) PERFORMANCE STATUS (0 OR 1 VS. 2) AND RANDOMIZED (1:1 RATIO) TO RECEIVE EITHER PANITUMUMAB (ADMINISTERED INTRAVENOUSLY 6 mg/kg EVERY 14 DAYS) PLUS BSC OR BSC AS DETERMINED BY INSTITUTIONAL STANDARDS. CROSS-OVER FROM THE BSC ARM TO THE PANITUMUMAB PLUS BSC ARM IS NOT PERMITTED ON STUDY. RADIOGRAPHIC TUMOR ASSESSMENTS AND INVESTIGATOR´S ASSESSMENT OF RESPONSE USING RECIST VERSION 1.1 (EISENHAUER ET AL, 2009, APENDIX G), WILL BE PERFORMED AT WEEK 4 (+1 WEEK), WEEK 8 (± 1 WEEK) AND THEN EVERY 8 WEEKS (± 1 WEEK), UNTIL DISEASE PROGRESSION (RADIOGRAPHIC OR CLINICAL PROGRESSION) (SEE APPENDIX 7). SUBJECTS WIL BE TREATED UNTIL DISEASE PROGRESSION, WITHDRAWAL OF CONSENT, DEATH, INTOLERANCE OF STUDY DRUG (FOR THOSE ON THE PANITUMUMAB PLUS BSC ARM), AND WILL BE FOLLOWED FOR SURVIVAL UNTIL WITHDRAWAL OF CONSENT, DEATH, OR THE END OF THE LONG-TERM FOLLOW-UP PERIOD (SEE SECTION 7.1.5.1). Study Design: THIS IS AN OPEN-LABEL, MULTICENTER, RANDOMIZED PHASE 3 STUDY WITH A PLANNED ENROLLMENT OF APPROXIMATELY 350 PATIENTS.

| 2563336 | ecrin-mdr-crc

Decision-making factors for best supportive care alone and prognostic factors after best supportive care in non-small cell lung cancer patients.

Project description:Among patients with non-small cell lung cancer (NSCLC), best supportive care (BSC) is well-known to improve patient's quality of life and prolong survival. This study aimed to clarify (1) the decision-making factors of BSC alone and (2) the prognostic factors after selection of no further anticancer therapies. We retrospectively reviewed the clinical data of patients with NSCLC between November 2004 and February 2014, who received BSC as only therapy and BSC after completion of anticancer therapies. One hundred eighteen patients received BSC alone. Among 860 patients treated with anticancer therapies, 236 were selected as control group, 160 of whom received BSC after anticancer therapy. The significant reasons for receiving BSC alone were: comorbidities of dementia, poor Eastern Cooperative Oncology Group performance status (ECOG-PS), patients' wishes, pulmonary comorbidities, wild type epidermal growth factor receptor (EGFR), relevant social background and psychiatric comorbidities. Poor prognostic factors at the start of BSC were poor ECOG-PS, presence of disseminated intravascular coagulation (DIC), and history of anticancer therapy. NSCLC patients with comorbidities, wild type EGFR, and relevant social background factors tended to receive BSC alone. Post-cancer therapy NSCLC patients and those with DIC and declining ECOG-PS have a shorter survival period from the start of BSC.

| S-EPMC6934749 | biostudies-literature

Chemotherapy plus best supportive care versus best supportive care in patients with non-small cell lung cancer: a meta-analysis of randomized controlled trials.

Project description:BackgroundThe use of chemotherapy has been proposed to increase the effectiveness of best supportive care (BSC) in patients with non-small cell lung cancer (NSCLC). Previous trials reported inconsistent findings regarding the efficacy and safety of chemotherapy on overall survival (OS) and treatment-related mortality. We performed a systematic review and meta-analysis to evaluate the effects of chemotherapy plus BSC versus BSC alone on survival of patients with NSCLC.Methodology and principal findingsWe systematically searched PubMed, EmBase, and the Cochrane Central Register of Controlled Trials for relevant literature. All eligible studies included patients with NSCLC who had received chemotherapy and BSC or BSC alone. All eligible studies measured at least 1 of the following outcomes: OS or treatment-related mortality. Overall, patients that received chemotherapy plus BSC had significant longer OS than those that received BSC alone (HR, 0.76; 95%CI, 0.69-0.84; P<0.001). Additionally, chemotherapy plus BSC as compared to BSC alone resulted in a 28% RR reduction (95%CI: 12-40; P = 0.001) in 6-month mortality, 11% RR reduction (95%CI: 8-15; P<0.001) in 12-month mortality, and 5% RR reduction (95%CI: 1-8; P = 0.02) in 2-year mortality. Toxicity was greater in patients that received chemotherapy plus BSC.Conclusion/significanceChemotherapy plus BSC increased the OS and reduced the 6-month, 12-month, and 2-year mortality of NSCLC patients.

| S-EPMC3603584 | biostudies-literature

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