A study of Docetaxel Lipid Suspension for Injection in patients with cancer of the head and neck
- Conditions
- Health Condition 1: C760- Malignant neoplasm of head, face and neck
- Registration Number
- CTRI/2017/12/010938
- Lead Sponsor
- Intas Pharmaceuticals Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
1. Patient willing and able to give informed consent to participate in the study.
2. Male and Female patients >=18 years and <=70 years of age at screening.
3. Patient with inoperable locally advanced squamous cell carcinoma of the head and neck
(SCCHN) who require docetaxel for induction therapy.
4. Patient should have at least one measurable lesion as per RECIST 1.1.
5. Patient must have an adequate bone marrow, renal, cardiac and hepatic function as defined by the following parameters.
6. Patient should be able to comply with study procedures in the opinion of the investigator.
7. Patient with a performance status of <= 1 according to the Eastern Cooperative Oncology
Group (ECOG).
8. Patient with Life expectancy more than six months.
9. Serum pregnancy test at screening and urine pregnancy test on Day 1 (before dosing) of
each cycle must be negative.
10. Male or Female patients or their partner must agree to use effective measures of
contraception during the study.
1. Patient with the history of hypersensitivity reactions to Taxanes or any other
component of formulation.
2. Chronic treatment with systemic steroids or another immunosuppressive agent or patient with severely immune compromised state.
3. Patients with an active, severe infection (e.g., tuberculosis, sepsis and opportunistic
infections).
4. Major surgery within 4 weeks prior to dosing or planned major surgery during the course of administration of study drug. However, surgery can be performed after end of treatment visit.
5. Patient treated with any previous radiotherapy and/or chemotherapy anytime in past for disease condition under study.
6. Patient with known CNS lesions (brain metastasis or carcinomatous meningitis).
7. Any history or presence of clinically significant cardiovascular, respiratory, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic,
neurologic, or psychiatric disease or any other condition which in the opinion of the
investigator could jeopardize the safety of the subject or the validity of the study results.
8. Patients with hepatitis B or hepatitis C infection or known case of HIV infection.
9. Pregnant or breast-feeding patients.
10. Pre-existing motor or sensory neurotoxicity of a severity >= grade 2 as defined by NCI
CTCAE 4.03 criteria.
11. Patients with a cancer diagnosis within the previous 5 years other than the disease condition under study and with the exception of treated non-melanoma skin cancer or carcinoma in situ of the cervix.
12. Patients with another active cancer other than the disease condition under study.
13. Patients who have undergone any previous definitive surgery for squamous-cell carcinoma of the head and neck.
14. Patients who have had severe weight loss ( >20% of body weight) in the preceding 3 months.
15. Patients with chronic obstructive pulmonary disease requiring hospitalization within the previous 12 months.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Evaluation of the efficacy of DOCEAQUALIP 20/80 (Docetaxel Lipid Suspension for Injection, in combination with cisplatin and 5-fluorouracil in the patients with inoperable <br/ ><br>locally advanced squamous cell carcinoma of the head and neck (SCCHN)Timepoint: Visit 1, 8, 14, 15, 16, 17, 18, 19
- Secondary Outcome Measures
Name Time Method safety and tolerability of DOCEAQUALIP in patients.Timepoint: Visit 1 to visit 19