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

Swami Rama Cancer Hospital and Research Institute

Status and phase: Unknown; Phase 3

Conditions: Lung Cancer; Locally Advanced and Metastatic Squamous Cell Carcinoma of the Lung; Squamous Cell Carcinoma of the Lung

Treatments: Drug: Intravenous Cisplatin & etoposide; Drug: Intravenous Cisplatin & etoposide along with oral cyclophosphamide

Study type: Interventional

Funder types: Industry

Identifiers

NCT01947062

MetroCyclo1

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Histopathologically proven squamous cell carcinoma of the lung
• Surgically unresectable or metastatic disease

Exclusion criteria

• Severe life limiting diabetes, hypertension or cardiac co-morbidities
• Co-existing tuberculosis
• Brain metastases at presentation
• Non-consenting patients
• Previously treated with any regimen of chemotherapy for existing or previous malignancy

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Standard intravenous chemotherapy

Active Comparator group

Description:

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

Treatment:

Drug: Intravenous Cisplatin & etoposide

Intravenous with metronomic chemotherapy

Experimental group

Description:

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

Treatment:

Drug: Intravenous Cisplatin & etoposide along with oral cyclophosphamide