Health Condition 1: C760- Malignant neoplasm of head, face and neck
Conditions
Interventions
Intervention1: DOCEAQUALIP 20/80
(DOCETAXEL LIPID SUSPENSION
FOR INJECTION 20/80 mg/vial of Intas Pharmaceuticals Limited, India: Dose: 75 mg/m2
Frequency: Every 3-weeks, Mode of Administration: Intra
Sponsors
Intas Pharmaceuticals Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patient willing and able to give informed consent to participate in the study. 2. Male and Female patients >=18 years and 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 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.
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 locally advanced squamous cell carcinoma of the head and neck (SCCHN)Timepoint: Visit 1, 8, 14, 15, 16, 17, 18, 19 | — |
Secondary
| Measure | Time frame |
|---|---|
| safety and tolerability of DOCEAQUALIP in patients.Timepoint: Visit 1 to visit 19 | — |
Countries
India
Contacts
Public ContactDr Ravi Alamchandani
Lambda Therapeutic Research Ltd
Outcome results
None listed