Stage IVA Colorectal Cancer AJCC v8 Clinical Trial
Official title:
A Phase II Study of TAS-102, Irinotecan and Bevacizumab in Pre-Treated Metastatic Colorectal Cancer (TABAsCO)
Verified date | August 2023 |
Source | Roswell Park Cancer Institute |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This phase II trial studies how well TAS-102, irinotecan, and bevacizumab work in treating patients with pre-treated colorectal cancer that has spread to other places in the body (metastatic) or cannot be removed by surgery (unresectable). Drugs used in chemotherapy, such as TAS-102, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Irinotecan may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Immunotherapy with bevacizumab, may induce changes in body's immune system and may interfere with the ability of tumor cells to grow and spread. Giving TAS-102, irinotecan, and bevacizumab may work better in treating patients with colorectal cancer compared to traditional chemotherapy and bevacizumab.
Status | Active, not recruiting |
Enrollment | 42 |
Est. completion date | July 17, 2024 |
Est. primary completion date | July 27, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Advanced colorectal cancer (metastatic or unresectable): Histologically or cytological proven adenocarcinoma of the colon or rectum which is metastatic or otherwise incurable - Prior treatment with a fluoropyrimidine (5-fluorouracil [5-FU] or capecitabine) and oxaliplatin in the metastatic/unresectable setting OR, recurrence within 12 months of adjuvant therapy with a regimen that included oxaliplatin - Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-1 - Hemoglobin >= 9 g/dL - Absolute neutrophil count >= 1500/mm^3 - Platelet count >= 100,000/mm^3 - Creatinine < 1.5 upper limit of normal (ULN) or if >= 1.5 x ULN creatinine clearance (CRCL) >= 30 mL/min (by Cockcroft-Gault) - Bilirubin < 1.5 x ULN - Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) =< 2.5 x ULN or =< 5 x ULN if with hepatic metastases - Have measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria present - Participants of child-bearing potential must agree to use adequate contraceptive methods (e.g., hormonal or barrier method of birth control; abstinence) prior to study entry. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately - Participant must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related procedure Exclusion Criteria: - Prior treatment with TAS-102 or irinotecan - Anti-cancer therapy within 2 weeks of the planned first dose of study medication - Unresolved toxicities from prior therapy of > grade 1, excluding alopecia or similar toxicities which are not deemed to be clinically significant or put the participant at greater risk. Grade 2 neuropathy is permitted - Major surgery within 4 weeks of anticipated start of therapy - Uncontrolled hypertension: systolic blood pressure >= 150, diastolic blood pressure >= 100 - Unstable angina, symptomatic congestive heart failure or cardiac arrhythmia requiring anti-arrhythmic therapy (beta-blockers, calcium channel blockers and digoxin are allowed) - Arterial or venous thrombotic or embolic events within 3 months of study initiation, unless well controlled on stable anti-coagulation for >= 2 weeks. This excludes uncomplicated catheter associated venous thrombosis - History of cerebrovascular or myocardial ischemia within 6 months of initiation - National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version (v) 5.0 grade 3 or greater hemorrhage within the past 4 weeks - Proteinuria >= 2+, unless 24 hour urine collection demonstrates =< 1 g of protein OR spot protein: creatinine demonstrates a ratio of =< 1 - Untreated brain metastases - History of abnormal glucuronidation of bilirubin (Gilbert's syndrome) - History of second primary malignancy within 3 years prior to enrollment, excluding in-situ cervical carcinoma, non-melanoma skin cancer or malignancy of equivalent risk which is highly unlikely to require systemic treatment in the next 2 years - Have known active infection which would heighten the risk of complications - Pregnant or nursing female participants - Unwilling or unable to follow protocol requirements - Any condition which in the investigator's opinion deems the participant an unsuitable candidate to receive study drug |
Country | Name | City | State |
---|---|---|---|
United States | Roswell Park Cancer Institute | Buffalo | New York |
United States | Rutgers Cancer Institute of New Jersey | New Brunswick | New Jersey |
United States | Fox Chase Cancer Center | Philadelphia | Pennsylvania |
United States | Moffitt Cancer Center | Tampa | Florida |
Lead Sponsor | Collaborator |
---|---|
Roswell Park Cancer Institute | National Comprehensive Cancer Network |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Median progression free survival (PFS) | Will be assessed via the Response Evaluation Criteria in Solid Tumors (RECIST) version (v)1.1 guidelines. The PFS will be summarized using standard Kaplan-Meier methods, where estimates of the median PFS and 6/12-month PFS rates will be obtained with 90% confidence intervals. | From treatment until disease progression, death due to disease, or last follow-up, assessed up to 2 years post-treatment | |
Secondary | Objective response rate (ORR) | ill be tabulated based upon RECIST v1.1 criteria. Will be summarized using frequencies and relative frequencies. Using Jeffrey's prior method, a 90% confidence interval about the true ORR will be obtained for each treatment group. | Up to 2 years post-treatment | |
Secondary | Median overall survival (OS) | OS will be summarized using standard Kaplan-Meier methods; where estimates of the median survival and 12-month rates are obtained with 90% confidence intervals | From the date of enrollment to the time of death, assessed up to 2 years post-treatment | |
Secondary | Disease-specific survival (DSS) | DSS will be summarized using standard Kaplan-Meier methods; where estimates of the median survival and 12-month rates are obtained with 90% confidence intervals. | From treatment until death due to disease or last follow-up, assessed up to 2 years post-treatment | |
Secondary | Aggregate rates of adverse events | easured by Common Terminology Criteria for Adverse Events (CTCAE) v5.0 and recorded to objectively measure toxicities of the combination therapy. Treatment related adverse events (as per CTCAE v5.0) will be summarized by grade using frequencies and | Up to 30 days after last dose of study drug |
Status | Clinical Trial | Phase | |
---|---|---|---|
Terminated |
NCT04832763 -
Medical and Psychosocial Issues in Adolescents and Young Adults With Colorectal Cancer
|
N/A | |
Active, not recruiting |
NCT04164069 -
Dasatinib for the Prevention of Oxaliplatin-Induced Neuropathy in Patients With Metastatic Gastrointestinal Cancer Receiving FOLFOX Chemotherapy With or Without Bevacizumab
|
Phase 1 | |
Active, not recruiting |
NCT03981614 -
Binimetinib and Palbociclib or TAS-102 in Treating Patients With KRAS and NRAS Mutant Metastatic or Unresectable Colorectal Cancer
|
Phase 2 | |
Completed |
NCT04597151 -
Diet Education Program for Stage I-IV Colorectal Cancer Survivors
|
N/A | |
Recruiting |
NCT04739072 -
Minimal Residual Disease Assessment in Patients With Colorectal Cancer, the MiRDA-C Study
|
||
Suspended |
NCT04111172 -
A Vaccine (Ad5.F35-hGCC-PADRE) for the Treatment of Gastrointestinal Adenocarcinoma
|
Phase 2 | |
Active, not recruiting |
NCT04362839 -
Regorafenib, Ipilimumab and Nivolumab for the Treatment of Chemotherapy Resistant Microsatellite Stable Metastatic Colorectal Cancer
|
Phase 1 | |
Active, not recruiting |
NCT04117945 -
Regorafenib, With Cetuximab or Panitumumab, for the Treatment of Unresectable, Locally Advanced, or Metastatic Colorectal Cancer
|
Phase 2 | |
Active, not recruiting |
NCT02983578 -
Danvatirsen and Durvalumab in Treating Patients With Advanced and Refractory Pancreatic, Non-Small Cell Lung Cancer, and Mismatch Repair Deficient Colorectal Cancer
|
Phase 2 | |
Recruiting |
NCT04693377 -
Cryoablation Combined With Stereotactic Body Radiation Therapy for the Treatment of Painful Bone Metastases, the CROME Trial
|
N/A | |
Completed |
NCT00862680 -
4D PET/CT in Diagnosing Participants With Lung and Colorectal Cancer With Liver and Lung Metastasis
|
||
Recruiting |
NCT04511039 -
Trifluridine/Tipiracil and Talazoparib for the Treatment of Patients With Locally Advanced or Metastatic Colorectal or Gastroesophageal Cancer
|
Phase 1 | |
Completed |
NCT04067960 -
Pharmacogenomics Testing in Directing the Optimal Use of Supportive Care Medications in Patients With Stage III-IV Cancer
|
Early Phase 1 | |
Recruiting |
NCT04017650 -
Encorafenib, Cetuximab, and Nivolumab in Treating Patients With Microsatellite Stable, BRAFV600E Mutated Unresectable or Metastatic Colorectal Cancer
|
Phase 1/Phase 2 | |
Recruiting |
NCT03844750 -
Preoperative Immunotherapy (Pembrolizumab) for Patients With Colorectal Cancer and Resectable Hepatic Metastases
|
Phase 2 | |
Active, not recruiting |
NCT03599752 -
Chemotherapy and/or Metastasectomy in Treating Patients With Metastatic Colorectal Adenocarcinoma With Lung Metastases
|
Phase 2 | |
Active, not recruiting |
NCT03993327 -
An Imaging Agent (I-124 M5A) in Detecting CEA-Positive Liver Metastases in Patients With Colorectal Cancer
|
Phase 1 | |
Withdrawn |
NCT03576963 -
Guadecitabine and Nivolumab in Treating Refractory Metastatic Colorectal Cancer
|
Phase 1/Phase 2 | |
Active, not recruiting |
NCT03844620 -
Circulating Cell-Free Tumor DNA Testing in Guiding Treatment for Patients With Advanced or Metastatic Colorectal Cancer
|
Phase 2 | |
Recruiting |
NCT04771520 -
Avapritinib for the Treatment of CKIT or PDGFRA Mutation-Positive Locally Advanced or Metastatic Malignant Solid Tumors
|
Phase 2 |