Rectal Cancer Clinical Trial
Official title:
An Open-label, Multicenter, Randomized Phase 2 Study Evaluating the Safety and Efficacy of 5 FU/FA and Oxaliplatin (Modified FOLFOX 6) in Combination With Ramucirumab or IMC-18F1 or Without Investigational Therapy as Second Line Therapy in Patients With Metastatic Colorectal Cancer Following Disease Progression on First Line Irinotecan-based Therapy
Verified date | July 2019 |
Source | Eli Lilly and Company |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study is to determine if participants with metastatic colorectal cancer live longer without their cancer progressing when treated with standard chemotherapy, standard chemotherapy plus ramucirumab, or standard chemotherapy plus icrucumab.
Status | Completed |
Enrollment | 158 |
Est. completion date | December 2013 |
Est. primary completion date | December 2013 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Disease progression on an irinotecan-based first-line chemotherapy regimen (ie FOLFIRI or CAPIRI [capecitabine + irinotecan], with or without bevacizumab) - Age = 18 years - Life expectancy of = 6 months - Eastern Cooperative Oncology Group Performance Status (ECOG PS) 0-1 at study entry - Agrees to adequate contraception during the study period and for 12 weeks after the last dose of study medication - Provided signed informed consent Exclusion Criteria: - Has received prior oxaliplatin-based chemotherapy for locally advanced unresectable or metastatic Colorectal Cancer (CRC) (Prior oxaliplatin-based adjuvant chemotherapy is allowed if the last dose of oxaliplatin was administered > 12 months prior to randomization) - Has documented and/or symptomatic brain or leptomeningeal metastases - Has an ongoing or active infection, symptomatic or poorly controlled cardiac arrhythmia, psychiatric illness/social situations, or any other serious uncontrolled medical disorders - On chronic non-topical corticosteroid treatment. A participant discontinuing such treatment > 3 months prior to randomization is eligible - Has uncontrolled or poorly controlled hypertension on a standard regimen of antihypertensive therapy - Has a concurrent active malignancy. A participant with previous history of malignancy is eligible, provided that he/she has been disease free for > 3 years - If female, is pregnant (confirmed by serum beta human chorionic gonadotropin [ßHCG] test) or lactating - Has received a prior autologous or allogeneic organ or tissue transplantation - Has undergone major surgery within 28 days prior to randomization - Has had a serious nonhealing wound, ulcer, or bone fracture within 28 days prior to randomization - Has an elective or planned major surgery to be performed during the course of the trial - Has a history of inflammatory bowel disease requiring pharmacological and/or surgical intervention in the 12 months prior to randomization |
Country | Name | City | State |
---|---|---|---|
Canada | ImClone Investigational Site | Calgary | Alberta |
Canada | ImClone Investigational Site | Edmonton | Alberta |
Canada | ImClone Investigational Site | Halifax | Nova Scotia |
Canada | ImClone Investigational Site | Hamilton | Ontario |
Canada | ImClone Investigational Site | Kelowna | British Columbia |
Canada | ImClone Investigational Site | London | Ontario |
Canada | ImClone Investigational Site | Mississauga | Ontario |
Canada | ImClone Investigational Site | Montreal | Quebec |
Canada | ImClone Investigational Site | Oshawa | Ontario |
Canada | ImClone Investigational Site | Ottawa | Ontario |
Canada | ImClone Investigational Site | Surrey | British Columbia |
Canada | ImClone Investigational Site | Toronto | Ontario |
Canada | ImClone Investigational Site | Vancouver | British Columbia |
Canada | ImClone Investigational Site | Windsor | Ontario |
United States | ImClone Investigational Site | Cincinnati | Ohio |
United States | ImClone Investigational Site | Columbia | South Carolina |
United States | ImClone Investigational Site | Nashville | Tennessee |
Lead Sponsor | Collaborator |
---|---|
Eli Lilly and Company |
United States, Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Progression-Free Survival (PFS) | PFS is defined as the time from baseline until the date of disease progression as defined by Response Evaluation Criteria in Solid Tumors (RECIST v1.1), or death from any cause, whichever was first. Participants who die without a reported prior progression will be considered to have progressed on the day of their death. Participants who did not progress, are lost to follow-up, or have missed two or more scheduled tumor assessments will be censored at the day of their last radiographic tumor assessment, if there are no post-baseline tumor measurements for a randomized and treated participant, the participant will be censored at the date of randomization. If death or progressive disease (PD) occurs after 2 or more missing radiographic visits, censoring will occur at the date of the last radiographic visit prior to the last visit. | Baseline until Disease Progression or Death from Any Cause (Up to 95 Weeks) | |
Secondary | Percentage of Participants Achieving Complete Response (CR) or Partial Response (PR) (Objective Response Rate [ORR]) | The ORR is the percentage of participants with Complete Response (CR, the disappearance of target lesions and any pathological lymph nodes [target or non-target] taking as reference the baseline sum of diameters in response to treatment) or Partial Response (PR, at least a 30% decrease in the sum of diameter of target lesions, taking as reference the baseline sum diameters in response to treatment) according to RECIST v1.1 from the start of the treatment until disease progression. | Baseline until Disease Progression (Up to 95 Weeks) | |
Secondary | Overall Survival (OS) | Overall survival is defined as the time from baseline to the date of death from any cause. If the participant is alive at the end of the follow-up period or is lost to follow-up, OS will be censored on the last date the participant is known to be alive. | Baseline Until Death from Any Cause (Up to 163 Weeks) | |
Secondary | Duration of Response (DoR) | DoR was measured from the time measurement criteria are first met for Complete Response or Partial Response or until the first date that the criteria for disease progression or death from any cause. whichever is first recorded. As defined according to RECIST v1.1, CR is the disappearance of all non-nodal target lesions, and PR is the short axes of any target lymph nodes reduced to < 10 mm and at least a 30% decrease in the sum of the diameters of target lesions including the short axes of any target lymph nodes.) | Criteria First Met for CR or PR until Disease Progression or Death from Any Cause (Up to 95 Weeks) | |
Secondary | Pharmacokinetics (PK): Maximum Concentration (Cmax) at Cycle 5 | Maximum concentration (1 hour post end of infusion, Cmax) is the concentration measured in serum. | Cycle 5, 1 Hour Post End of Infusion | |
Secondary | Pharmacokinetics (PK): Trough Serum Concentrations (Ctrough) at Cycle 5 | Trough (prior to infusion, Ctrough) concentrations measured in serum. | Cycle 5, Prior to Infusion | |
Secondary | Maximum Concentration (Cmax) at Day 8 | Maximum concentration (Cmax) is the maximum peak concentration measured in blood plasma after drug infusion. | Day 8 (cycles 1 and 5) | |
Secondary | Maximum Concentration (Cmax) at Day 15 | Cmax is the maximum peak concentration measured in blood plasma after drug infusion. | Day 15 (Cycles 1 and 5) | |
Secondary | Minimum Concentration (Cmin) at Day 1 | Cmin is the minimum peak concentration measured in blood plasma after drug infusion. | Day 1 (cycles 1, 5, 9, and 13) | |
Secondary | Minimum Concentration (Cmin) at Day 4 | Cmin is the minimum peak concentration measured in blood plasma after drug infusion. | Day 4 (cycles 1 and 5) | |
Secondary | Minimum Concentration (Cmin) at Day 8 | Minimum concentration (Cmin) is the minimum peak concentration measured in blood plasma after drug infusion. | Day 8 (cycles 1 and 5) | |
Secondary | Minimum Concentration (Cmin) at Day 15 | Minimum concentration (Cmin) is the minimum peak concentration measured in blood plasma after drug infusion. | Day 15 (cycles 1 and 5) | |
Secondary | Number of Participants With Serum Ramucirumab Antibody Assessment | A sample will be considered positive for anti-Ramucirumab antibodies if it exhibits a post-baseline antibody level exceeding the normal anti-Ramucirumab antibody level seen in healthy untreated individuals. | 31 Weeks | |
Secondary | Serum Anti-Icrucumab Antibody Assessment | A sample will be considered positive for anti-icrucumab antibodies if it exhibits a post-baseline antibody level exceeding the normal anti-icrucumab antibody level seen in healthy untreated individuals. | 31 Weeks | |
Secondary | Number of Participants With Adverse Events | A summary of serious AEs (SAEs) and all other non-serious AEs regardless of causality, is located in the Reported Adverse Events module. | Baseline up to 165 weeks |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT06380101 -
Evaluating a Nonessential Amino Acid Restriction (NEAAR) Medical Food With Total Neoadjuvant Therapy for Locally Advanced Rectal Cancer (LARC)
|
N/A | |
Active, not recruiting |
NCT05551052 -
CRC Detection Reliable Assessment With Blood
|
||
Recruiting |
NCT04323722 -
Impact of Bladder Depletion on Mesorectal Movements During Radiotherapy in Rectal Cancer
|
N/A | |
Recruiting |
NCT06006390 -
CEA Targeting Chimeric Antigen Receptor T Lymphocytes (CAR-T) in the Treatment of CEA Positive Advanced Solid Tumors
|
Phase 1/Phase 2 | |
Active, not recruiting |
NCT04088955 -
A Digimed Oncology PharmacoTherapy Registry
|
||
Active, not recruiting |
NCT01347697 -
Collagen Implant (Biological Mesh) Versus GM Flap for Reconstruction of Pelvic Floor After ELAPE in Rectal Cancer
|
N/A | |
Recruiting |
NCT04495088 -
Preoperative FOLFOX Versus Postoperative Risk-adapted Chemotherapy in Patients With Locally Advanced Rectal Cancer
|
Phase 3 | |
Withdrawn |
NCT03007771 -
Magnetic Resonance-guided High-Intensity Focused Ultrasound (MR-HIFU) Used for Mild Hyperthermia
|
Phase 1 | |
Terminated |
NCT01347645 -
Irinotecan Plus E7820 Versus FOLFIRI in Second-Line Therapy in Patients With Locally Advanced or Metastatic Colon or Rectal Cancer
|
Phase 1/Phase 2 | |
Not yet recruiting |
NCT03520088 -
PROSPECTIVE CONTROLLED AND RANDOMIZED STUDY OF THE GENITOURINARY FUNCTION AFTER RECTAL CANCER SURGERY IN RELATION TO THE DISSECTION OF THE INFERIOR MESENTERIC VESSELS
|
N/A | |
Recruiting |
NCT05556473 -
F-Tryptophan PET/CT in Human Cancers
|
Phase 1 | |
Recruiting |
NCT04749381 -
The Role of TCM on ERAS of Rectal Cancer Patients
|
Phase 2 | |
Enrolling by invitation |
NCT05028192 -
Mitochondria Preservation by Exercise Training: a Targeted Therapy for Cancer and Chemotherapy-induced Cachexia
|
||
Recruiting |
NCT03283540 -
Transanal Total Mesorectal Excision for Rectal Cancer on Anal Physiology + Fecal Incontinence
|
||
Completed |
NCT04534309 -
Behavioral Weight Loss Program for Cancer Survivors in Maryland
|
N/A | |
Recruiting |
NCT05914766 -
An Informational and Supportive Care Intervention for Patients With Locally Advanced Rectal Cancer
|
N/A | |
Recruiting |
NCT04852653 -
A Prospective Feasibility Study Evaluating Extracellular Vesicles Obtained by Liquid Biopsy for Neoadjuvant Treatment Response Assessment in Rectal Cancer
|
||
Recruiting |
NCT03190941 -
Administering Peripheral Blood Lymphocytes Transduced With a Murine T-Cell Receptor Recognizing the G12V Variant of Mutated RAS in HLA-A*11:01 Patients
|
Phase 1/Phase 2 | |
Completed |
NCT02810652 -
Perioperative Geriatrics Intervention for Older Cancer Patients Undergoing Surgical Resection
|
N/A | |
Terminated |
NCT02933944 -
Exploratory Study of TG02-treatment as Monotherapy or in Combination With Pembrolizumab to Assess Safety and Immune Activation in Patients With Locally Advanced Primary and Recurrent Oncogenic RAS Exon 2 Mutant Colorectal Cancer
|
Phase 1 |