Clinical trial NCT01947062: Metronomic Cyclophosphamide in Combination With Standard Chemotherapy for Squamous Cell Lung Carcinoma
Official title: Evaluation of the Benefits of Oral Metronomic Cyclophosphamide in Combination With Standard Cisplatin-etoposide Based Chemotherapy for Squamous Cell Lung Carcinoma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Lung Cancer
Squamous Cell Carcinoma of the Lung
Locally Advanced and Metastatic Squamous Cell Carcinoma of the Lung
Keywords: NSCLC
Metronomic chemotherapy
Metronomic cyclophosphamide
Lead sponsor: Swami Rama Cancer Hospital and Research Institute
Sponsor class: INDUSTRY
First posted: 2013-09-20
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Progression free survival
timeFrame: 12 months on average
Secondary outcomes:
measure: Response rate
timeFrame: 12 months on average
Other outcomes:
Locations:
city: Haldwani, Nainital
country: India
facility: Swami Rama Cancer Hospital & Research Institute
state: Uttarakhand
Study officials:
References: