A study to develop individualized dosing strategy of docetaxel based on a mathematical model in elderly patients with cancer.

Not Applicable

Conditions: Health Condition 1: C509- Malignant neoplasm of breast of unspecified siteHealth Condition 2: C760- Malignant neoplasm of head, face and neckHealth Condition 3: C61- Malignant neoplasm of prostateHealth Condition 4: C169- Malignant neoplasm of stomach, unspecifiedHealth Condition 5: C349- Malignant neoplasm of unspecifiedpart of bronchus or lung

Registration Number: CTRI/2020/03/024027

Lead Sponsor: Advanced Cancer for Treatment Research and Education in cancer

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Open to Recruitment

Sex: Not specified

Target Recruitment: 0

Inclusion Criteria

1. Cytological or histological confirmed diagnosis of one of the aforementioned cancers

2. Patients advised docetaxel based chemotherapy and receiving first cycle of treatment

3. Aged 65 years and above

4. Adequate liver function defined as total bilirubin less or equal to 2 times upper limit of normal (ULN), SGOT and SGPT less or equal to 3 times ULN in the absence of liver metastasis and less or equal to 5 times ULN in the presence of liver metastasis

5. Haemoglobin greater or equal to 8 g per dL

7. ECOG PS less or equal to 2

8. Willing to consent for the study

Exclusion Criteria

1. Patients on concomitant drugs which are cytochrome inducers or inhibitors, apart from those which are routinely prescribed along with chemotherapy (eg. Antiemetics and steroids are allowed).

2. Serious co-morbid conditions, including severe cancer cachexia, which in the opinion of the investigator may affect the disposition of drugs.

3. Patients with cancer cachexia (weight loss greater than 5%, or weight loss greater than 2% in individuals already showing depletion according to current body weight and height (BMI less than 20 kg per m2).

4. Patients with known brain metastasis

Study & Design

Study Type: Observational

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Development a PopPK model of docetaxel in geriatric patients (Age greater or equal to 65 years)Timepoint: Development a PopPK model of docetaxel in geriatric patients (Age greater or equal to 65 years)

Secondary Outcome Measures

Name	Time	Method
1. Correlation between docetaxel disposition and response <br/ ><br>2.Correlation between docetaxel disposition and toxicity <br/ ><br>3. Identify the pharmacogenetic factors, co-variates which affect the inter-individual variability of docetaxel in geriatric patients <br/ ><br>Timepoint: 4 Years