Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 2:12 PM
Ignite Modification Date:
2025-12-24 @ 2:12 PM
NCT ID:
NCT00256295
Brief Summary:
The combination of oxaliplatin and gemcitabine is highly active in a wide variety of tumors including pancreatic, germ cell, breast, biliary, mesothelioma (Mitchell et al, 2002), and lung. In the last study which utilized days 1 and 8 gemcitabine 1000 mg/m2 and days 1 and 8 oxaliplatin 65 mg/m2 in poor prognosis lung cancer patients (PS 1-3) the response rate was 16% with no incidence of febrile neutropenia.
Toxicity is a crucial consideration when designing regimens intended for palliation. Toxicities associated with cisplatin can make it difficult to use in patients with Head and Neck Cancer (HNC), many of whom are elderly and have comorbidities. In addition, many patients with metastatic HNC have previously received cisplatin during neoadjuvant/adjuvant therapy, or as part of their primary chemoradiation treatment. When these patients recur, it is possible their tumors have innate or acquired cisplatin resistance. Oxaliplatin is likely to be better tolerated than cisplatin containing regimens, especially with regards to neurotoxicity. Gemcitabine has shown promising activity as a single agent and in combination chemotherapy in the first line treatment of patients with HNC. A combination chemotherapy regimen using oxaliplatin and gemcitabine administered once every week is logical and worth exploring in patients with metastatic and recurrent head and neck cancer to improve the toxicity profile and patient monitoring while maintaining efficacy of the chemotherapy regimen.
Study:
NCT00256295
Study Brief:
Protocol Section:
NCT00256295