Cisplatin and Pemetrexed With Radiation Followed by Lobectomy - Full Text View

Purpose

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.

Condition	Intervention	Phase
Nonsquamous Nonsmall Cell Neoplasm of Lung Nonsmall Cell Lung Cancer Stage III	Drug: Pemetrexed Drug: Carboplatin Radiation: Radiation Therapy Drug: Cisplatin Procedure: Lobectomy	Phase 1


Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Masking: Open Label Primary Purpose: Treatment
Official Title:	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)

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lung Cancer

Drug Information available for: Cisplatin Carboplatin Pemetrexed Pemetrexed disodium

U.S. FDA Resources

Further study details as provided by Medical University of South Carolina:

Primary Outcome Measures:

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.

Secondary Outcome Measures:

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)


Enrollment:	48
Study Start Date:	May 2011
Study Completion Date:	June 2012
Primary Completion Date:	June 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Arm A Patients will be given the drugs pemetrexed and carboplatin Radiation Participants evaluated for response Lobectomy surgery	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. Procedure: Lobectomy Surgery
Experimental: Arm B Patients will be given the drugs pemetrexed and cisplatin Radiation Participants evaluated for response Lobectomy surgery	Drug: Pemetrexed Pemetrexed by vein every 21 days for 3 cycles Drug: Cisplatin Cisplatin by vein every 21 days for 3 cycles Radiation: Radiation Therapy Radiation treatment 5 days a week for 5-6 weeks. Procedure: Lobectomy Surgery to remove a portion of the lung where the tumor is located.

Eligibility


Ages Eligible for Study:	18 Years to 90 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01373463

Locations


United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29425

Sponsors and Collaborators

Medical University of South Carolina

More Information

No publications provided


Responsible Party:	George Simon, MD, Hollings Cancer Cetner Medical University of South Carolina
ClinicalTrials.gov Identifier:	NCT01373463 History of Changes
Other Study ID Numbers:	101466
Study First Received:	June 13, 2011
Last Updated:	July 24, 2012
Health Authority:	United States: Institutional Review Board

Keywords provided by Medical University of South Carolina:


resectable

Additional relevant MeSH terms:


Carcinoma, Non-Small-Cell Lung Bronchial Neoplasms Carcinoma, Bronchogenic Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms Carboplatin	Cisplatin Pemetrexed Antimetabolites Antimetabolites, Antineoplastic Antineoplastic Agents Enzyme Inhibitors Folic Acid Antagonists Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Radiation-Sensitizing Agents Therapeutic Uses

ClinicalTrials.gov processed this record on February 27, 2015

Cisplatin and Pemetrexed With Radiation Followed by Lobectomy (CisPemXetSrg)