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Phase I Study Evaluating Indomethacin in Combination With Platinum-based Chemotherapy

Phase 1
18 Years
70 Years
Open (Enrolling)
Colorectal Neoplasms, Esophageal Neoplasms, Gastric Neoplasms

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Trial Information

Phase I Study Evaluating Indomethacin in Combination With Platinum-based Chemotherapy

Inclusion Criteria:

- Subjects with histological proven esophageal carcinoma receiving ECX (epirubicine,
cisplatin, capecitabine) (Arm I), patients receiving CAPOX (oxaliplatin,
capecitabine) (Arm II).

- Age ≥ 18 years and < 70 years.

- Platinum-based chemotherapy naïve for at least 6 months.

- Subjects with at least one evaluable lesion.

- WHO Performance Status of 0 or 1.

- Female participants should be of non-child bearing potential either physiologic or by
using adequate contraception, have a negative serum pregnancy test, and refrain from
breast feeding.

- Written informed consent.

Exclusion Criteria:

- Known or suspected allergy or hypersensitivity to indomethacin or any agent given in
association with this trial, in particular subjects who have a history of severe
hypersensitivity reactions to anti-emetics (5-HT3 antagonists, metoclopramide or
corticosteroids) and acetylsalicylic acid or other prostaglandin synthethase

- Symptomatic brain or meningeal tumors

- Subjects with seizure disorder requiring medication (such as corticosteroids or

- Any of the following concurrent severe and/or uncontrolled medical conditions which
could compromise participation in the study:

- Uncontrolled high blood pressure, history of labile hypertension, or history of poor
compliance with an antihypertensive regimen

- Unstable angina pectoris

- Symptomatic congestive heart failure NYHA class ≥ 3 (see appendix 13.6)

- Myocardial infarction ≤ 6 months prior to randomization

- Serious uncontrolled cardiac arrhythmia

- Active peptic ulcer disease, gastritis, inflammatory bowel disease.

- History of active gastro-intestinal bleeding

- History of cerebro-vascular disease

- Bleeding diathesis

- Chronic renal disease defined as GFR (MDRD) <60 ml/min

- Absolute Neutrophil Count (ANC) < 1.5 x 109/L (< 1500/mm3)

- Platelets (PLT) < 100 x 109/L (< 100,000/mm3)

- Hemoglobin (Hgb) < 6.0 mmol/l (patients may be transfused to achieve adequate Hb)

- Partial thromboplastin time (PTT) > 1,5 x ULN

- Serum bilirubin > 1.5 ULN

- Aspartate aminotransferase (AST/SGOT) and alanine aminotransferase (ALT/SGPT) > 3.0
x ULN (> 5 x ULN if liver metastases present)

- Patients who are unable or unwilling to comply with the protocol

- Chronic treatment with a corticosteroid agent (nebulized corticosteroids are allowed)

- Patients who received radiation therapy within 4 weeks of the start of the study

- Patients who received an experimental agent less than 4 weeks before start of the

- Patients who used Omega-3/omega-6 containing products, including fish oil products
less than 2 weeks before start of the study.

- Chronic use of NSAID's and/or acetylsalicylic acid and/or other prostaglandin
synthethase inhibitors.

- Use of anticoagulant therapy

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label

Outcome Measure:

Number of dose limiting toxicities at each dosage cohort

Outcome Time Frame:

From first dose of indomethacin until 28 days after last dose of indomethacin

Safety Issue:


Principal Investigator

E.E. Voest, MD/PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

UMC Utrecht


Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Study ID:




Start Date:

September 2012

Completion Date:

July 2014

Related Keywords:

  • Colorectal Neoplasms
  • Esophageal Neoplasms
  • Gastric Neoplasms
  • Colorectal
  • Esophageal
  • Indomethacin
  • PIFA
  • Neoplasms
  • Colorectal Neoplasms
  • Esophageal Diseases
  • Esophageal Neoplasms
  • Stomach Neoplasms