Cisplatin and Pemetrexed With Radiation Followed by Lobectomy (CisPemXetSrg)

• ClinicalTrials.gov Identifier: NCT01373463
• Recruitment Status: Terminated
• First Posted: June 15, 2011
• Last Update Posted: July 26, 2012
• Sponsor: Medical University of South Carolina
• Information provided by: Medical University of South Carolina

Study Description

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.

Condition or disease	Intervention/treatment	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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 48 participants
• Allocation: Non-Randomized
• Masking: None (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)
• Study Start Date: May 2011
• Actual Primary Completion Date: June 2012
• Actual Study Completion Date: June 2012

Arms and Interventions

Arm	Intervention/treatment
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.

Outcome Measures

Primary Outcome Measures :

1. Safety and tolerability
   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 :

1. Response rate, overall survival and progression free survival

   Evaluate the following:

   • Response Rate after concurrent chemoradiation therapy.
   • Overall Survival (OS).
   • Progression Free Survival (PFS)

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 90 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• 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

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

• Responsible Party: George Simon, MD, Hollings Cancer Cetner Medical University of South Carolina
• ClinicalTrials.gov Identifier: NCT01373463
• Other Study ID Numbers: 101466
• First Posted: June 15, 2011
• Last Update Posted: July 26, 2012
• Last Verified: July 2012

Keywords provided by Medical University of South Carolina:

resectable

Additional relevant MeSH terms:

Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms; Cisplatin; Carboplatin; Pemetrexed; Antineoplastic Agents; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Folic Acid Antagonists; Nucleic Acid Synthesis Inhibitors