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

Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01947062
• Other study ID #: MetroCyclo1
• Status: Not yet recruiting
• Phase: Phase 3
• First received: September 10, 2013
• Last updated: September 17, 2013
• Start date: October 2013
• Est. completion date: October 2014

Study information

• Verified date: September 2013
• Source: Swami Rama Cancer Hospital and Research Institute
• Contact: Swaroop Revannasiddaiah, MD
• Phone: +91
• Email: swarooptheone[@]gmail.com
• Is FDA regulated: No
• Health authority: India: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: October 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Squamous Cell
• Locally Advanced and Metastatic Squamous Cell Carcinoma of the Lung
• Lung Cancer
• Lung Neoplasms
• Squamous Cell Carcinoma of the Lung

Intervention

Drug:
• Intravenous Cisplatin & etoposide
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 along with oral cyclophosphamide
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.

Locations

Country	Name	City	State
India	Swami Rama Cancer Hospital & Research Institute	Haldwani, Nainital	Uttarakhand

Sponsors (1)

Lead Sponsor	Collaborator
Swami Rama Cancer Hospital and Research Institute

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression free survival		12 months on average	No
Secondary	Response rate		12 months on average	No