Health Condition 1: null- Gastric adenocarcinoma failed one line of chemotherapy
Conditions
Interventions
Intervention1: Carbazitaxel: 20mg/m2 Intravenous given every 3 weeks.
Control Intervention1: Nil: Nil
Sponsors
Dr Raju Titus Chacko
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male or female patient >= 18 years of age. 2. Written informed consent must be obtained prior to any study related procedures. 3. Life expectancy of at least 3 months. 4. Histologically or cytologically confirmed gastric or esophagogastric junction adenocarcinoma with or without prior taxane therapy. 5. Measurable disease as per RECIST criteria (Version 1.1). 6. Eastern Cooperative Oncology Group (ECOG) performance status 0-1. 7. Adequate hematologic function (ANC >= 1500 cells/µL: Hemoglobin>= 9gm/dl, Platelets >= 1.0 lakh/mm3). 8. Adequate renal function (Serum creatinine 9. Serum bilirubin 10. Female patients must have a negative serum pregnancy test at baseline (not applicable to patients with bilateral oophrectomy and/ or hysterectomy or to those patients who are > 1 year postmenopausal). 11. All patients of reproductive age group must agree to use of an approved form of contraception. 12. Patients who have failed at least one line of therapy for stage IV stomach cancer or should have relapsed with either local and unresectable or metastatic disease within 6 months prior after end of (neo) adjuvant chemotherapy for localized gastric cancer (prior chemotherapy given to increase radiosensitivity will not be considered as prior palliative chemotherapy if it was not continued after end of radiotherapy). 13. Should have completed at least 4 weeks from last chemotherapy. 14. Should have completed at least 6 weeks from last radiotherapy.
Exclusion criteria
Exclusion criteria: 1. Known allergy to taxanes and GCSF. 2. Grade 2 or higher peripheral neuropathy (e.g. numbness, tingling and/or pain in distal extremities. 3. Prior hypersensitivity to polysorbate 80. 4. Symptomatic or clinically active CNS disease or metastatic lesions (prior radiotherapy to brain metastases is allowed). 5. Major surgery within last 4 weeks and end of prior radiotherapy within last 6 weeks. 6. Pregnant or breast feeding women. 7. Uncontrolled intercurrent disease (diabetes, hypertension, thyroid disease). 8. Any history of angina pectoris, coronary artery disease or cerebrovascular disease or transient ischemic attack. 9. Cardiac arrhythmia requiring medical therapy. 10. Known chronic infection with HIV, Hepatitis B and C. 11. History of gastric bleeding or presence of deeply ulcerated tumor. 12. History of gastric inlet or outlet obstruction. 13. Other gastric tumor type (lymphoma, leyomyosarcoma etc.) 14. Patients unwilling to comply with the study procedures.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Disease control rate defined as the clinical benefit rateTimepoint: 6 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| identification of known and novel gene modifications involved in Chemo-resistance to Carbazitaxel.Timepoint: beginning of study and at progression;Overall SurvivalTimepoint: one year;Quality of lifeTimepoint: before each cycle of chemotherapy;safety of CarbazitaxelTimepoint: During and after the administration of carbazitaxel | — |
Countries
India
Contacts
Public ContactDr Raju Titus Chacko
Christian Medical College
Outcome results
None listed