Active clinical trials for "Colorectal Neoplasms"

RATIONALE: ISIS 2503 may kill cancer cells by inhibiting a gene that promotes the development and growth of cancer. PURPOSE: Phase II trial to study the effectiveness of ISIS 2503 in treating patients who have metastatic and/or locally recurrent colorectal cancer.

Management of older cancer patients is challenging, due to a lack of good quality evidence to guide treatment decisions, as well as the wide variability in the level of fitness for treatment of elderly patients. Oncologists are faced with the challenge of determining the most suitable treatment for an individual taking into account their comorbidities, competing causes of death, quality of life and functional reserve. Colorectal cancer (CRC) is the second leading cause of cancer-related deaths in the western world and ranks second among the most frequent malignancies in Europe in both men and women. The incidence and mortality of CRC strongly increases with age. Approximately 60% of new cases of CRC and 70% of CRC-related deaths occur in patients aged 65 years and older, with about 40% of patients aged 75 years or older. The oncologists' therapeutic decision-making for elderly patients with metastatic colorectal cancer (mCRC) has been largely debated in the last few years, mainly because of the lack of trial-based recommendations, due to the underrepresentation of patients more than 65 years old in clinical trials. As a consequence, therapeutic choices in this setting are frequently driven by data from retrospective, pooled and meta-analyses. These results do not necessarily reflect the general population affected with mCRC and are often limited by potential confounding factors. It is well recognized that chronological age is not an effective criterion on which to base therapeutic decisions. Rather, treatment tolerability in an older cancer patient is primarily related to physiological or biological age, that is the level of fitness, which takes into account factors such as functional status and comorbidities. Physiological age is better assessed with a comprehensive geriatric assessment (CGA), a multidisciplinary evaluation covering domains such as cognitive and mood status, functionality, comorbidities, and nutrition. These deficits are prevalent in older patients but which may be missed with routine evaluation. There is now strong evidence that use of a CGA assessment in a general geriatric patient population can improve health outcomes. While some form of geriatric assessment have been recommended by specialist advisory panels for all elderly patients in whom chemotherapy is considered, evidence of CGA leading to improved outcomes in a geriatric population with cancer is very limited. CGA for older patients with cancer does appear to provide information relating to prognosis, likelihood of toxicity from chemotherapy, and has been shown to influence treatment decisions. However, this approach is time-consuming, leading cancer specialists to seek an easier screening tool that can separate fit older patients with cancer, who are able to receive standard cancer treatment, from vulnerable patients that should subsequently receive a full assessment to guide tailoring of their treatment regimen. The G8 is a simple 8-items screening tool, developed specifically for older patients with cancer. This tool, addressed by the clinician, covers multiple domains, focusing on nutritional status, mobility, neuropsychological problems, medication use, self-rated health status and age. The G8 demonstrated a good sensitivity in identifying patients with impairments across multiple domains when a cut-off of 14 points is adopted. Patients with a score < 14 would be candidate to a CGA. Nevertheless, this cut-off showed poor specificity and negative predictive value. Furthermore, some evidences suggested that the G8 might be able to predict survival, while its predictive value for treatment-related toxicities has not been extensively explored. While literature data support a promising role for G8 as a simple cost-effective screening tool in elderly patients, to date its use in clinical practice is not widespread, and only selected centers with a focus in geriatric oncology routinely perform this assessment to enhance the baseline evaluation of patients before treatment choice. The lack of ''real life population'' data makes it difficult to evaluate the role of G8 in the setting of common practice in an unselected population and to prove its efficacy and reliability outside selected cases. Moreover, recent data suggest how a physical performance test, such as Timed Up and Go, could be a useful indicators of prognosis, functional decline and treatment-related complications. This study is designed to promote a comprehensive evaluation of elderly patients before treatment decisions and to prospectively evaluate the association of G8 assessment with clinical outcome and treatment-related severe toxicity in the real life population of elderly patients with colorectal cancer in Veneto. Additionally, preliminary data on feasibility and reliability of Timed Up and Go measurement as prognostic determinant and dynamic marker, will be collected.

This randomized trial studies how well panitumumab, leucovorin calcium, and fluorouracil after combination chemotherapy and panitumumab induction work in treating patients with RAS wild type colorectal cancer that has spread from where it started to nearby tissue or lymph nodes or other places in the body or cannot be removed by surgery. Monoclonal antibodies, such as panitumumab, may interfere with the ability of tumor cells to grow and spread. Drugs used in chemotherapy, such as leucovorin calcium, fluorouracil, and oxaliplatin, 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. Giving panitumumab, leucovorin calcium, and fluorouracil after combination chemotherapy and panitumumab induction may work better in treating patients with colorectal cancer.

This study will include two parts: In the phase I part: safety will be assessed in consecutive cohorts of 3 to 6 patients at increasing doses of TG6002 in combination with oral flucytosine (5-FC) in patients with advanced gastro-intestinal (GI) tumors. In the phase IIa part: evaluation of efficacy and further evaluation of safety of multiple administrations of TG6002 in combination with flucytosine (5-FC) in patients with colorectal cancer and liver metastases. In both parts, tumor response will be evaluated on local assessment using RECIST 1.1. All patients will be followed up until disease progression or death due to any cause or the date of data cut-off, whichever occurs first.

This is a Phase 2, randomized, open-label, 3-arm trial in the ratio of 1:1:1 to either Sym004 (Arm A) versus each of its component monoclonal antibodies (mAbs), futuximab (Arm B) or modotuximab (Arm C), in genomically-selected patients with chemotherapy-refractory metastatic colorectal carcinoma (mCRC) and acquired resistance to anti-epidermal growth factor receptor (anti-EGFR) mAb therapy. The study is designed to evaluate the relative antitumor activity of each agent as assessed by imaging studies performed after 8 weeks of treatment.

This is a multicenter, open-label, Phase 1 study of SC-006 given as a single agent and in combination with ABBV-181 in participants with advanced colorectal cancer (CRC), and consists of Part A (single agent SC-006 dose regimen finding), followed by Part B (single agent SC-006 dose expansion), and Part C (SC-006 and ABBV-181 combination escalation and expansion). Part A (dose regimen finding) will involve dose escalation and possible dose interval modification to define the maximum tolerated dose (MTD) and/or recommended Part B dose and schedule. Part B (dose expansion) will enroll additional participants who will be treated with a study drug dose at or below the MTD determined in Part A. Part C is dose escalation of SC-006 and fixed dose of ABBV-181 in combination. Recommended dose cohort of SC-006 with ABBV-181 will be expanded.

This is a single arm open label pilot phase II trial of Regorafenib PO plus 5-FU/LV infusion in 15 mCRC patients who progressed on prior Regorafenib monotherapy as well as 5-FU containing chemotherapy combinations.The study will enroll mCRC patients with prior progression on standard multi-agent combination chemotherapy and progression on regorafenib monotherapy.

This is a first-in-human, Phase 1, open label, multicenter, multiple dose, dose escalation and dose expansion study intended to evaluate the safety, pharmacokinetic, pharmacodynamic, and potential clinical benefit of PF-07209960, an anti-PD-1 targeting IL-15 fusion protein, in participants with selected locally advanced or metastatic solid tumors for whom no standard therapy is available, or would not be an appropriate option in the opinion of the participant and their treating physician, or participants who have refused standard therapy. The study contains 2 parts, single agent Dose Escalation (Part 1) to determine the recommended dose of PF-07209960, followed by Dose Expansion (Part 2) in selected tumor types at the recommended dose.

This is a single center, open-label, nonrandomized, Phase 1b, dose-escalation study designed to determine maximum tolerated dose (MTD) of CKD-516 in combination with durvalumab and evaluate the safety and tolerability profile, efficacy of CKD-516 and durvalumab treatment.

The purpose of this study is to evaluate the efficacy and safety of selinexor alone or with pembrolizumab in participants with advanced or metastatic colorectal cancer (CRC). Approximately 78 participants with advanced or metastatic CRC will be enrolled, and randomized (1:1:1) into three arms A (selinexor only), B (selinexor and pembrolizumab), and C (standard of care [Combination of trifluridine and tipiracil]). Randomization will be based on stratification factors: Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 versus 2. The end of treatment (EoT) visit will occur less than or equal to (<=30) days post-treatment discontinuation. A survival follow-up visit will be performed every 3 months from EoT and will continue for 12 months.