Phase I interaction study of Docetaxel and Tolbutamide with supplementation of Milk Thistle

Recruiting

• Conditions: cancer; malignant tumors; 10006291

• Registration Number: NL-OMON39305
• Lead Sponsor: Antoni van Leeuwenhoek Ziekenhuis

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 11 June 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 10

Inclusion Criteria

1. Patients for whom treatment with docetaxel is considered to be of therapeutic benefit, e.g. advanced breast, gastric, esophagus, bladder, ovarian cancer and non-small cell lung cancer, head and neck cancer and prostate cancer
2. Histological or cytological proof of cancer
3. Age >= 18 years
4. WHO performance status of 0, 1 or 2
5. Patient is able and willing to give written informed consent
6. Patient is able and willing to swallow and retain oral medication
7. Patient is able and willing to undergo blood sampling for pharmacokinetics
8. Patient is willing to comply to the protocol and to follow dietary restrictions
9. Life expectancy > 3 months allowing adequate follow up of toxicity evaluation and antitumor activity
10. Minimal acceptable safety laboratory values
a. ANC of >= 1.5 x 10^9 /L
b. Platelet count of >= 100 x 10^9 /L
c. Hepatic function as defined by serum bilirubin <= 1.5 x ULN, ALAT and ASAT <= 2.5 x ULN
d. Renal function as defined by serum creatinine <= 1.5 x ULN or creatinine clearance >= 50 ml/min (by Cockcroft-Gault formula).
11. No radio- or chemotherapy within the last 4 weeks prior to study entry, except for pain palliation.

Exclusion Criteria

1. Any treatment with investigation drugs within 30 days before the start of the study
2. Women who are pregnant or breast feeding
3. Concomitant use of MDR, CYP2C9 and CYP3A modulating drugs, food or drinks such as amiodaron, fluconazole, ketoconazole, clarithromycin, rifampicin, Ca2+-entry blockers (verapamil, dihydropyridines), cyclosporine, quinidine, quinine, tamoxifen, megestrol, grapefruit juice, concomitant use of HIV medications; other protease inhibitors, (non) nucleoside analogs, or St. John*s wort;
4.Unreliable contraceptive methods. Both men and women enrolled in this trial must agree to use a reliable contraceptive method throughout the study (adequate contraceptive methods are: condom, contraceptive pill (female partner), abstinence from sexual intercourse, sterilisation of man or woman).
5. Legal incapacity
6. Type I and II diabetes mellitus patients
7. Chronic use of H2-receptor antagonists or proton pump inhibitors
8. Unresolved (>grade 1) toxicities of previous chemotherapy
9. Bowel obstruction or motility disorders that may influence the absorption of drugs
10. Neurologic disease that may render a patient at increased risk for peripheral or central neurotoxicity
11. Symptomatic cerebral or leptomeningeal metastases
12. Uncontrolled infectious disease or known HIV-1 or HIV-2 type patients
13. Use of herbal supplements, especially milk thistle, within 6 weeks prior to study treatment.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The most important parameter is the plasma concentration of docetaxel and<br /><br>tolbutamide and the course of this concentration with time in the presence or<br /><br>absence of milk thistle. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary parameters are toxicities that patients experience from docetaxel in<br /><br>the presence or absence of milk thistle. </p><br>