Cisplatin and Pemetrexed With Radiation Followed by Lobectomy (CisPemXetSrg)

This study has been terminated.

(Investigator left site)

Sponsor:

Information provided by:

Medical University of South Carolina

ClinicalTrials.gov Identifier:

NCT01373463

First received: June 13, 2011

Last updated: July 24, 2012

Last verified: July 2012

History of Changes

Tracking Information
First Received Date ^ICMJE	June 13, 2011
Last Updated Date	July 24, 2012
Start Date ^ICMJE	May 2011
Primary Completion Date	June 2012 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: January 24, 2012)	Safety and tolerability [ Designated as safety issue: Yes ] Determine the safety and tolerability of concurrent chemotherapy with Cisplatin/ Pemetrexed or Carboplatin/Pemetrexed and dose escalated radiation therapy followed by lobectomy.
Original Primary Outcome Measures ^ICMJE	Not Provided
Change History	Complete list of historical versions of study NCT01373463 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: January 24, 2012)	Response rate, overall survival and progression free survival [ Designated as safety issue: No ] Evaluate the following: Response Rate after concurrent chemoradiation therapy. Overall Survival (OS). Progression Free Survival (PFS)
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Cisplatin and Pemetrexed With Radiation Followed by Lobectomy
Official Title ^ICMJE	A Phase I Trial of Preoperative Carboplatin or Cisplatin and Pemetrexed With Thoracic Radiation Therapy Followed by Lobectomy in Resectable Stage III Patients With Non-Squamous Non Small Cell Lung Cancer (NSCLC)
Brief Summary	This study is open to patients that have been diagnosed with non-squamous Stage III Non Small Cell Lung Cancer (NSCLC) and will have surgery to remove the tumor. The purpose of this study is to: Test a combination of two chemotherapeutic drugs along with radiation therapy, when given prior to surgery and see what effects (good or bad) it has on someone with this type of cancer. Chemotherapeutic drugs selectively destroy diseased cancer cells and tissues. Test the safety of different dose levels of radiation when given with each combination of chemotherapy; Determine what side effects are associated with combining radiation with these two chemotherapy combinations.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 1
Study Design ^ICMJE	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Nonsquamous Nonsmall Cell Neoplasm of Lung Nonsmall Cell Lung Cancer Stage III
Intervention ^ICMJE	Drug: Pemetrexed Pemetrexed by vein every 21 days for 3 cycles Drug: Carboplatin Carboplatin by vein Every 21 days for 3 cycles Radiation: Radiation Therapy Radiation treatment 5 days a week for 5-6 weeks. Drug: Cisplatin Cisplatin by vein every 21 days for 3 cycles Procedure: Lobectomy Surgery Procedure: Lobectomy Surgery to remove a portion of the lung where the tumor is located.
Study Arm (s)	Experimental: Arm A Patients will be given the drugs pemetrexed and carboplatin Radiation Participants evaluated for response Lobectomy surgery Interventions: Drug: Pemetrexed Drug: Carboplatin Radiation: Radiation Therapy Procedure: Lobectomy Experimental: Arm B Patients will be given the drugs pemetrexed and cisplatin Radiation Participants evaluated for response Lobectomy surgery Interventions: Drug: Pemetrexed Drug: Cisplatin Radiation: Radiation Therapy Procedure: Lobectomy
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Terminated
Enrollment ^ICMJE	48
Completion Date	June 2012
Primary Completion Date	June 2012 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: Histologically and cytologically confirmed non-squamous NSCLC. Resectable T3, and or N2 disease (T3N1, and resectable T1-3N2 multi-station non-bulky with no nodal station being more than 2 cm on preoperative workup, T4N0-1 Resectable T3 includes patients with a satellite lesion in the same lobe as the primary. Male or Female, aged > or = 18 years and be able to give informed consent. Tumor should be technically operable with a lobectomy, bilobectomy or a sleeve resection. Patient should be medically operable ECOG Performance Status 0 or 1. Adequate bone marrow, hepatic and renal function assessed within 28 days Signed informed consent. Women of childbearing potential should have negative pregnancy test prior to enrollment to study. Men with partners in the childbearing age group and women of childbearing potential must use effective contraception while on treatment and for 6 months thereafter. The ability to interrupt NSAIDS 2 days before (5 days for long-acting NSAIDs), the day of, and 2 days following administration of Pemetrexed. The ability to take folic acid, Vitamin B12, and dexamethasone according to protocol. Patients must have a negative MRI or CT Scan of the brain. Exclusion Criteria: Patients who have had chemotherapy or radiation therapy within 4 weeks prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier. Patients may not be receiving any other investigational agents. History of allergic reactions attributed to compounds or other agents used in study. Pregnant or lactating women. Male patients with female sexual partners in the reproductive age group who refuse to use effective methods of contraception will be excluded from the trial. Patients with concurrent serious infections. Patients with an unstable or serious concurrent medical condition are excluded. Presence of third space fluid which cannot be controlled by drainage. Weight loss > 10 percent from baseline weight. HIV-positive patients on combination antiretroviral therapy are ineligible Patients with hypercalcemia will be excluded. Patients who require a pneumonectomy will be excluded.
Gender	Both
Ages	18 Years to 90 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT01373463
Other Study ID Numbers ^ICMJE	101466
Has Data Monitoring Committee	Yes
Responsible Party	George Simon, MD, Hollings Cancer Cetner Medical University of South Carolina
Study Sponsor ^ICMJE	Medical University of South Carolina
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Medical University of South Carolina
Verification Date	July 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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