TAS-102 for Cancer

Phase-Based Estimates
1
Effectiveness
1
Safety
University of Wisconsin Carbone Cancer Center, Madison, WI
Cancer+3 More
TAS-102 - Drug
Eligibility
18+
All Sexes
Eligible conditions
Cancer

Study Summary

This study is evaluating whether a combination of two drugs may be more effective than either drug alone.

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Eligible Conditions

  • Cancer
  • Neoplasms
  • Neuroendocrine Tumors
  • Tumors
  • Malignancies

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Compared to trials

Study Objectives

This trial is evaluating whether TAS-102 will improve 2 primary outcomes and 6 secondary outcomes in patients with Cancer. Measurement will happen over the course of Up to 2 years.

Up to 2 years
Part 1: Maximum Tolerated Dose (MTD) of TAS-102
Up to 5 years
Part 2: Biochemical Response defined as normalization or >50% reduction in levels of Chromogranin A
Part 2: Disease Control Rate
Part 2: Duration of Response
Part 2: Overall Response Rate
Part 2: Overall Survival
Part 2: Progression Free Survival (PFS)
Part 2: Safety and Tolerability, Assessed per RECIST Criteria

Trial Safety

Safety Estimate

1 of 3

Compared to trials

Trial Design

2 Treatment Groups

Control
TAS-102 and TMZ

This trial requires 18 total participants across 2 different treatment groups

This trial involves 2 different treatments. TAS-102 is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 1 and are in the first stage of evaluation with people.

TAS-102 and TMZPart 1: dose-escalation phase to determine MTD of TAS-102 in combination with Temozolomide (TMZ). Treatment cycles are 28 days, with TAS-102 administered orally twice daily days 1-5 and 8-12, and TMZ administered orally days 8-12. No treatment medications administered days 13-28 of each cycle. Growth factor support is required during Part 1 and should be dosed per institutional standards. Part 2: expansion phase to evaluate preliminary efficacy of MTD. Subjects treated with the recommended phase 2 drug doses determined in part 1. Treatment will continue for up to 13 cycles (approx. 12 months). Growth factor support is allowed during Part 2 and should be dosed per institutional standards.
ControlNo treatment in the control group
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
TAS-102
Not yet FDA approved
Temozolomide
FDA approved
Filgrastim
FDA approved
Pegfilgrastim
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 5 years
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly up to 5 years for reporting.

Closest Location

University of Wisconsin Carbone Cancer Center - Madison, WI

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Grade 1 and 2 tumors that have not been surgically removed and have spread to other parts of the body are considered to be unresectable or metastatic pNETs. show original
The life expectancy for someone who is suffering from the disease is more than three months. show original
ECOG performance status is a measure of a person's ability to function in their everyday life show original
The patient had measurable disease by RECIST 1.1 criteria in the liver and in the lungs show original
Individuals with metastatic or advanced NETs of any origin or grade can enroll in the study. show original
In order to be evaluable, an individual must have either a measurable disease or evidence of disease by imaging studies or other tests show original
The following medications can be used together as long as the dosage has been stable for at least 8 weeks: somatostatin analogues. show original
Participants must have previously received chemotherapy or radiation therapy (including Y90) at least 2 weeks before study enrollment. show original
or ANC ≥ 1500 A person has an ANC of ≥ 1.5 x 10^9/L or an ANC of ≥ 1500 if their absolute neutrophil count is greater than or equal to 1.5 x 10^9/L or 1,500 respectively. show original
Hemoglobin ≥ 9 g/dL

Patient Q&A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What causes cancer?

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Every cancer is a different disease, and as people get older they develop new diseases that can be hard to diagnose and manage if found. Most cancers cannot be blamed on any single factor, and there is still a great deal to explore in this area of cancer biology.

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What are common treatments for cancer?

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Cancers are often managed with medication and non-specific surgery. Common options include chemotherapy, hormonal therapy, and radiation therapy. Very rarely does curative surgery replace non-specific surgery. When these methods fail or do not work, and when the cancer has already become inoperable, a tumor with many viable cells may be left to shrink spontaneously. This can be used to make life easier for patients with metastatic cancers and for those that are otherwise incurable. However, if life becomes unbearable, even after many months or even years, then a "bridge therapy" will be attempted.

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How many people get cancer a year in the United States?

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Cancer kills an average of 952,000 people in the United States a year, making it the most common cause of death apart from heart disease. This number is based on data derived from the US National Cancer Institute's SEER Program data. Cancer is more the leading cause of death than cardiovascular disease for all non-Hispanic whites, American men, and women.

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Can cancer be cured?

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Cancer must be treated like any other disease, in terms of identifying and treating risk factors and not simply killing cancer cells. In the context of cancer medicine, 'curing cancer' can only be defined by a clinical trial of an agent or regimen that has previously been shown (in trials) to be effective in treating cancers generally, and the definition is limited by the inability to identify all cancers that 'cure' based upon these trials. Furthermore, some cancer treatments, such as immunotherapy agents, may not have 'cure' as an aim of treatment or definition of efficacy, therefore preventing 'curing' by definition.

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What is cancer?

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The study of cancer should include a description of the characteristics of cancer cells and a definition of the different types of cancer. These should also include a description of the cause of cancer and factors that might lead to its cure. Cancer treatment requires information about the histological and molecular characteristics of carcinomas, the response of specific histological subtypes of carcinoma to specific therapies, the specific features of specific carcinomas in relation to each other, and information on the treatment of metastases, which is currently the most significant issue affecting prognosis. Cancer cells must be kept in culture and their morphology compared to normal cells as a method of determining their specific properties.

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What are the signs of cancer?

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Signs of cancer include lump, bump, lumps, or growths in a place not normally found. Also, cancer might cause unexplained weight loss, and bleeding or bruising that does not go away. A routine physical examination can spot and stop bleeding.\n\nFor infants and toddlers, physical signs of cancer that are important to note are the size and nature of the tumours. Infants and toddlers are unaware of their tumours, so the early signs of cancer are often found by accident. These include poor feeding (an increased appetite), weight loss, poor growth, lethargy, swelling in the legs and groin, swollen neck nodes, fever, diarrhoea, vomiting, constipation and jaundice.

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What is the latest research for cancer?

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The following is a sample of some recent research articles that have been cited in this article. These articles are a selection from a large group of recent research.\n\n- Clinical trial participation for cancer treatment should be discouraged because of potential harm.\n- Some treatments, especially the use of taxoids for breast cancer, are associated with an increased risk of death in those treated. Additional trials have shown that taxoids may help women with breast cancer.\n- There are problems with trial methodology and reporting; some trials have not properly reported on important details about trial methodology.\n- There is a need for better communication between researchers, doctors and patients.

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What are the common side effects of tas-102?

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Tas-102 can be administered as an adjunct therapy to chemotherapy. The side effects observed to date indicate that tas-102 may be effective as a prophylaxis in the treatment of cancer.

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Who should consider clinical trials for cancer?

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Most end-users could not benefit adequately from cancer trials. Trial sponsors and patients knew little about the cost; end-users did not fully understand the risks and disadvantages of research. A multistakeholder approach to trial design and evaluation is urgently needed.

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What is the survival rate for cancer?

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Many factors can affect the survival of a cancer patient but the main determinants for survival are the stage of the disease and the type of treatment used. For most cancers, the survival is dependent on the stage of the disease, which can be assessed through imaging studies of the tumor. Imaging studies can allow a doctor to determine the extent of the cancer and determine the best type of treatment needed for this specific patient. For patients with liver cancer, resection is the best form of treatment with regards to survival rates and may be followed by adjuvant therapy. In lung cancer, in addition to resection, chemotherapy is the most common form of treatment.

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How does tas-102 work?

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The effects of aldose reductase inhibition by tas-102 in human renal carcinoma cells were dependent upon the specific cell line and the specific aldose reductase isoform studied. The antiproliferative effects were dose-dependent and aldose reductase inhibition by tas-102 led to increased cellular oxidative stress, p53 induction, and apoptosis. Results from a recent clinical trial are similar to what has been observed with other AR inhibitors. Results from a recent clinical trial further indicate that the effects of aldose reductase inhibition by tas-102 may need to be evaluated at a tumor cell line and isoform selectivity level in order to fully understand tas-102 inhibition of renal carcinomas.

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How quickly does cancer spread?

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Many misconceptions about cancer are rooted in erroneous beliefs about tumor behavior. Misconceptions may impede appropriate cancer-related medical, financial, and psychosocial care for patients and families and can potentially delay treatment.

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