Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Lung Neoplasms

Carcinoma

Carcinoma, Squamous Cell

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Neoplasms, Squamous Cell

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Antineoplastic Agents

All Drugs and Chemicals

Antirheumatic Agents

Etoposide

Cyclophosphamide

Cisplatin

Etoposide phosphate

Immunosuppressive Agents

Immunologic Factors

Antineoplastic Agents, Alkylating

Alkylating Agents

Enzyme Inhibitors

Patients will receive standard intravenous chemotherapy based on cisplatin and etoposide.

Patients will receive both intravenous (cisplatin and etoposide based) and metronomic chemotherapy (with oral cyclophosphamide).

Patients will receive standard intravenous cisplatin and etoposide based chemotherapy, for a total of six cycles, delivered at three-weekly intervals. In each cycle, the dose of cisplatin will be at 50mg/m2 on days 1 \& 2. The dose of etoposide will be 100mg/m2 on days 1, 2 \& 3.

Intravenous Cisplatin & etoposide

Patients will be treated with oral cyclophosphamide at a daily dose of 50mg. Patients will also receive standard intravenous cisplatin and etoposide based chemotherapy, for a total of six cycles, delivered at three-weekly intervals. In each cycle, the dose of cisplatin will be at 50mg/m2 on days 1 \& 2. The dose of etoposide will be 100mg/m2 on days 1, 2 \& 3.

Intravenous Cisplatin & etoposide along with oral cyclophosphamide

Swaroop Revannasiddaiah, MD

Kailash C Pandey, MD

Sridhar P Susheela, MD

Treatment of locally advanced and metastatic squamous cell carcinoma of the lung involves the use of chemotherapy as the therapeutic mainstay. Platinum-etoposide regimens (such as cisplatin-etoposide) are the most commonly used chemotherapeutic regimen, which is delivered intravenously in the standard three-weekly intervals.

Recent interest in oral metronomic chemotherapy has arisen, especially due to its beneficial effects in delaying disease progression among heavily pre-treated patients with various malignancies.

This study attempts to combine the use of metronomic chemotherapy concurrently during standard intravenous chemotherapy.

Adenocarinoma and squamous cell carinoma are the two major types of non-small cell lung carcinoma. While patients with adenocarcinoma of the lung have the feasibility of treatment with tyrosine kinase inhibitors, the patients with squamous cell carcinoma can only be treated with standard chemotherapy due to the ineffectiveness of tyrosine kinase inhibitors. Thus, the current standard is to treat patients of squamous cell lung cancers with standard intravenous chemotherapy, which is mostly delivered once in three weeks.

Metronomic chemotherapy, meaning the delivery of low doses of chemotherapy, often by an oral approach, on a daily basis so as to maintain a low but definite level of the chemotherapy has received great interest in recent times due to its beneficial effects in terms of extending progression free survival among patients of various malignancies, even after failure with previous conventional therapies. Metronomic chemotherapy is proposed to be active by alternate mechanisms, such as the predominant anti-angiogenic effect, in contrast to the cytotoxic and genotoxic effects of standard chemotherapy.

Metronomic chemotherapy with oral cyclophosphamide has been shown to extend progression free survival when used as a single agent in various malignancies. Given the fact that progression after varying time spans is a rule (rather than the exception) among patients of squamous cell lung cancer being treated with conventional chemotherapy, we have intended to combine the use of oral metronomic chemotherapy given concurrently with standard intravenous cisplatin-etoposide based chemotherapy. We intend to observe a prolongation of progression free survival.

Metronomic Cyclophosphamide in Combination With Standard Chemotherapy for Squamous Cell Lung Carcinoma

Evaluation of the Benefits of Oral Metronomic Cyclophosphamide in Combination With Standard Cisplatin-etoposide Based Chemotherapy for Squamous Cell Lung Carcinoma

Swami Rama Cancer Hospital and Research Institute

Assistant Professor, Radiotherapy & Clinical Oncology

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Metronomic Cyclophosphamide in Combination With Standard Chemotherapy for Squamous Cell Lung Carcinoma	NCT01947062	Lung Cancer Squamous Cell C... Locally Advance...	Intravenous Cis... Intravenous Cis...	18 Years - 75 Years	Swami Rama Cancer Hospital and Research Institute
Metronomic Cyclophosphamide in Combination With Standard Chemotherapy for Squamous Cell Lung Carcinoma	NCT01947062	Lung Cancer Squamous Cell C... Locally Advance...	Intravenous Cis... Intravenous Cis...	18 Years - 75 Years	Swami Rama Cancer Hospital and Research Institute

Spots Global Cancer Trial Database for intravenous cisplatin & etoposide along with oral cyclophosphamide