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Cisplatin and Pemetrexed With Radiation Followed by Lobectomy (CisPemXetSrg)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01373463
Recruitment Status : Terminated (Investigator left site)
First Posted : June 15, 2011
Last Update Posted : July 26, 2012
Information provided by:

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
Primary Completion Date : June 2012
Study Completion Date : June 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Arm A
  1. Patients will be given the drugs pemetrexed and carboplatin
  2. Radiation
  3. Participants evaluated for response
  4. 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
Experimental: Arm B
  1. Patients will be given the drugs pemetrexed and cisplatin
  2. Radiation
  3. Participants evaluated for response
  4. 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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01373463

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     History of Changes
Other Study ID Numbers: 101466
First Posted: June 15, 2011    Key Record Dates
Last Update Posted: July 26, 2012
Last Verified: July 2012

Keywords provided by Medical University of South Carolina:

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Folic Acid Antagonists
Nucleic Acid Synthesis Inhibitors