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

NCT ID: NCT01947062

Last Updated: 2013-09-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-10-31

Study Completion Date

2014-10-31

Brief Summary

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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

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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.

Conditions

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Lung Cancer Squamous Cell Carcinoma of the Lung Locally Advanced and Metastatic Squamous Cell Carcinoma of the Lung

Keywords

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NSCLC Metronomic chemotherapy Metronomic cyclophosphamide

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Standard intravenous chemotherapy

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

Group Type ACTIVE_COMPARATOR

Intravenous Cisplatin & etoposide

Intervention Type DRUG

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 with metronomic chemotherapy

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

Group Type EXPERIMENTAL

Intravenous Cisplatin & etoposide along with oral cyclophosphamide

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type DRUG

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.

Intervention Type DRUG

Other Intervention Names

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Control arm Standard intravenous chemotherapy Experimental arm Intravenous with metronomic chemotherapy

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Swami Rama Cancer Hospital and Research Institute

INDUSTRY

Sponsor Role lead

Responsible Party

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Swaroop Revannasiddaiah

Assistant Professor, Radiotherapy & Clinical Oncology

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Swami Rama Cancer Hospital & Research Institute

Haldwani, Nainital, Uttarakhand, India

Site Status

Countries

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India

Central Contacts

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Swaroop Revannasiddaiah, MD

Role: CONTACT

Phone: +91

Email: [email protected]

Kailash C Pandey, MD

Role: CONTACT

Phone: +91

Email: [email protected]

Facility Contacts

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Swaroop Revannasiddaiah, MD

Role: primary

Other Identifiers

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MetroCyclo1

Identifier Type: -

Identifier Source: org_study_id