What side effects are associated with this type of intervention?

Common treatments for intestinal carcinoma, such as Temozolomide and Capecitabine, have several known side effects. Temozolomide often causes nausea, vomiting, fatigue, and myelosuppression. Capecitabine, which is metabolized to 5-fluorouracil, can lead to diarrhea, hand-foot syndrome, nausea, and myelosuppression. Patients undergoing these treatments may experience a combination of these side effects, and it is important to manage them under the guidance of a healthcare provider.

What prior FDA approvals exist?

For the treatment of Intestinal Carcinoma, the FDA has approved several drugs that work through mechanisms similar to Temozolomide and Capecitabine. Capecitabine, which is metabolized to 5-fluorouracil (5-FU), has been approved for use in colorectal cancer, including metastatic cases. 5-FU itself, often combined with leucovorin, is a cornerstone in the treatment of colorectal cancer. Oxaliplatin, another FDA-approved drug, is frequently used in combination with 5-FU and leucovorin (FOLFOX regimen) for colorectal cancer. These treatments focus on inhibiting DNA synthesis and causing DNA damage to kill cancer cells, similar to the mechanisms of Temozolomide and Capecitabine.

What other types of research exist?

Promising novel alternatives to Temozolomide and Capecitabine for Intestinal Carcinoma patients include: <ol> <li>Immunotherapy agents such as Pembrolizumab and Nivolumab, which have shown efficacy in various gastrointestinal cancers.</li> <li></li> </ol> Targeted therapies like Trastuzumab Deruxtecan for HER2-positive cancers. 3. Combination regimens involving newer agents like Tucatinib with Capecitabine and Trastuzumab, particularly for HER2-positive cases. 4. PARP inhibitors such as Olaparib for patients with BRCA mutations. These alternatives are based on recent clinical trials and advancements in the field.

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Anti-metabolites

Chemotherapy for Neuroendocrine Cancer

Phase 2

Waitlist Available

Led By Jennifer Eads

Research Sponsored by ECOG-ACRIN Cancer Research Group

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2

Serum creatinine =< 1.5 X institutional ULN and creatinine clearance >= 60 ml/min

Must not have

Patients with a history of allergic reactions attributed to compounds of similar chemical or biochemical composition to cisplatin, carboplatin, etoposide, temozolomide or capecitabine

Patients with symptomatic heart failure, unstable angina pectoris, cardiac arrhythmia or a serious psychiatric illness/social situation that would limit compliance with study requirements are not eligible

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

Summary

This trial is studying temozolomide and capecitabine to see how well they work compared to standard treatment with cisplatin or carboplatin and etoposide in treating patients with neuroendocrine carcinoma of the gastrointestinal tract or pancreas.

Who is the study for?

This trial is for adults with advanced, inoperable or metastatic neuroendocrine carcinoma of the gastrointestinal tract or pancreas. They should not have had prior systemic treatment for this cancer and must be physically well enough to participate (ECOG 0-2). Participants need functioning major organs, no severe allergies to study drugs, no other cancers unless specific conditions are met, and cannot be pregnant. Effective contraception is advised.Check my eligibility

What is being tested?

The trial compares two chemotherapy regimens: temozolomide plus capecitabine versus cisplatin or carboplatin with etoposide. It aims to determine which combination is more effective against certain types of neuroendocrine carcinomas that haven't responded well to standard treatments.See study design

What are the potential side effects?

Possible side effects include nausea, vomiting, fatigue, low blood cell counts leading to increased infection risk and bleeding problems, liver and kidney function changes. Rarely there may be allergic reactions or hand-foot syndrome where hands or feet become swollen and painful.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I can take care of myself and am up and about more than half of my waking hours.

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My kidney function tests are within normal limits.

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I do not have any serious infections, heart issues, or mental health conditions that would prevent me from following the study's requirements.

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I have no allergies to specific cancer drugs like cisplatin or carboplatin.

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I haven't had a heart attack, unstable angina, or blood clots in my arteries in the last year.

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I do not have problems absorbing medications.

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I am not taking Coumadin but may be on other blood thinners.

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My cancer is confirmed as non-small cell lung cancer through a biopsy.

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I do not have a known DPD deficiency.

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My cancer is a type that started in my stomach or pancreas and cannot be surgically removed.

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I do not have symptoms from peripheral vascular disease.

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I am not pregnant or breast-feeding.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am allergic to certain chemotherapy drugs like cisplatin or carboplatin.

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I do not have serious heart issues, unstable chest pain, irregular heartbeats, or major psychiatric/social situations that would prevent me from following the study's requirements.

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I can absorb medications properly.

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I do not have HIV or take antiretroviral therapy.

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I do not have brain metastases or carcinomatous meningitis.

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I do not have any active or uncontrolled infections.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

PFS

Secondary outcome measures

Incidence of toxicity, graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0

Response rate (complete response or partial response) by RECIST 1.1

Other outcome measures

Ki-67 as a continuous measure assessed by immunohistochemistry (IHC)

Ki-67 measured centrally

Ki-67 measured with registering institutions? pathology assessments

+3 more

Side effects data

From 2020 Phase 2 & 3 trial • 151 Patients • NCT03093870

63%

Nausea

58%

Fatigue

54%

Diarrhoea

50%

Decreased Appetite

46%

Vomiting

42%

Pyrexia

42%

Hypokalaemia

38%

Abdominal Pain

33%

Blood Bilirubin Increased

33%

Constipation

29%

Abdominal Distension

29%

Hyponatraemia

29%

Dizziness

29%

Oedema Peripheral

29%

Back Pain

25%

Hypotension

25%

Stomatitis

25%

Palmar-plantar Erythrodysaethesia Syndrome

25%

Dehydration

25%

Anaemia

21%

Dyspnoea

21%

Aspartate Aminotransferase Increased

21%

Chills

21%

Dyspepsia

21%

Asthenia

21%

Proteinuria

17%

Platelet Count Decreased

17%

Alanine Aminotransferase Increased

17%

Rash

17%

Ascites

13%

Cough

13%

Abdominal Pain Upper

13%

Hypomagnesaemia

13%

Blood Creatinine Increased

13%

Hyperbilirubinaemia

13%

Dry mouth

13%

Dyspnoea exertional

13%

Weight Decreased

13%

Hypoalbuminaemia

13%

Muscular weakness

13%

Urinary tract infection

Influenza like illness

Gamma-glutamyltransferase increased

Paraesthesia

Dysphonia

Malaise

Faeces discolored

International normalised ratio increased

Hypoaesthesia

Gastrooesophageal Reflux Disease

Depression

Hypoglycemia

Acute Kidney Injury

Enterocolitis

Hematemesis

Hyperkalaemia

Hypocalcaemia

Blood alkaline phosphatase increased

Epistaxis

Bile duct obstruction

Oral pain

Neutrophil Count Decreased

Myalgia

Insomnia

Early satiety

Rhinitis allergic

Bursitis

Musculoskeletal pain

Anxiety

Dysgeusia

Acute kidney injury

Cholangitis

Cardiac arrest

Rash generalized

Respiratory Failure

Septic shock

Small intestinal obstruction

Spinal cord compression

Toxic leukoencephalopathy

Peripheral Sensory Neuropathy

Haematemesis

Hypercalcaemia

Hyponatremia

Hypoxic-ischaemic encephalopathy

Ischaemic stroke

Lung Infection

Metabolic acidosis

Aspiration

100%

80%

60%

40%

20%

Study treatment Arm

Placebo and Capecitabine - Part 1

Varlitinib and Capecitabine - Safety Lead-In

Varlitinib and Capecitabine - Part 1

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Arm A (capecitabine, temozolomide)Experimental Treatment3 Interventions

Patients receive capecitabine PO BID on days 1-14 and temozolomide PO QD on days 10-14. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Group II: Arm B (cisplatin, carboplatin, etoposide)Active Control4 Interventions

Patients receive cisplatin IV on days 1-3 or carboplatin IV on day 1. Patients also receive etoposide IV on days 1-3. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Temozolomide

2010

Completed Phase 3

~1930

Capecitabine

2013

Completed Phase 3

~3420

0 / 18Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Temozolomide and Capecitabine are common treatments for Intestinal Carcinoma due to their specific mechanisms of action. Temozolomide is an alkylating agent that damages DNA, leading to cancer cell death. Capecitabine is a prodrug that is metabolized into 5-fluorouracil (5-FU), which inhibits DNA synthesis by targeting thymidylate synthase. These mechanisms are crucial as they directly interfere with the cancer cells' ability to replicate and survive, providing a targeted approach to treatment that can improve patient outcomes.