Cisplatin and Pemetrexed With Radiation Followed by Lobectomy (CisPemXetSrg)

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)

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.

Study Overview

• Status: Terminated
• Conditions: Nonsquamous Nonsmall Cell Neoplasm of Lung; Nonsmall Cell Lung Cancer Stage III
• Intervention / Treatment: Drug: Pemetrexed; Drug: Carboplatin; Radiation: Radiation Therapy; Procedure: Lobectomy; Procedure: Lobectomy; Drug: Cisplatin

• Study Type: Interventional
• Enrollment (Actual): 48
• Phase: Phase 1

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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; Procedure: Lobectomy; Surgery to remove a portion of the lung where the tumor is located.
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; Radiation: Radiation Therapy; Radiation treatment 5 days a week for 5-6 weeks.; Procedure: Lobectomy; Surgery; Procedure: Lobectomy; Surgery to remove a portion of the lung where the tumor is located.; Drug: Cisplatin; Cisplatin by vein every 21 days for 3 cycles

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description
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

Outcome Measure	Measure Description
Response rate, overall survival and progression free survival	Evaluate the following: Response Rate after concurrent chemoradiation therapy.; Overall Survival (OS).; Progression Free Survival (PFS)

Collaborators and Investigators

• Sponsor: Medical University of South Carolina

Study record dates

Study Major Dates

• Study Start: May 1, 2011
• Primary Completion (Actual): June 1, 2012
• Study Completion (Actual): June 1, 2012

Study Registration Dates

• First Submitted: June 13, 2011
• First Submitted That Met QC Criteria: June 14, 2011
• First Posted (Estimate): June 15, 2011

Study Record Updates

• Last Update Posted (Estimate): July 26, 2012
• Last Update Submitted That Met QC Criteria: July 24, 2012
• Last Verified: July 1, 2012

More Information

Terms related to this study

• Keywords: resectable
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Molecular Mechanisms of Pharmacological Action; Nucleic Acid Synthesis Inhibitors; Enzyme Inhibitors; Antineoplastic Agents; Folic Acid Antagonists; Carboplatin; Pemetrexed
• Other Study ID Numbers: 101466