Cisplatin and Pemetrexed With Radiation Followed by Lobectomy

Nonsquamous Nonsmall Cell Neoplasm of Lung Clinical Trial

— CisPemXetSrg  

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)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01373463
• Other study ID #: 101466
• Status: Terminated
• Phase: Phase 1
• First received: June 13, 2011
• Last updated: July 24, 2012
• Start date: May 2011
• Est. completion date: June 2012

Study information

• Verified date: July 2012
• Source: Medical University of South Carolina
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 48
• Est. completion date: June 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Nonsmall Cell Lung Cancer Stage III
• Nonsquamous Nonsmall Cell Neoplasm of Lung

Intervention

Drug:
• Pemetrexed
Pemetrexed by vein every 21 days for 3 cycles
• Carboplatin
Carboplatin by vein Every 21 days for 3 cycles

Radiation:
• Radiation Therapy
Radiation treatment 5 days a week for 5-6 weeks.

Drug:
• Pemetrexed
Pemetrexed by vein every 21 days for 3 cycles
• 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
• Lobectomy
Surgery to remove a portion of the lung where the tumor is located.

Locations

Country	Name	City	State
United States	Medical University of South Carolina	Charleston	South Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of South Carolina

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		Yes
Secondary	Response rate, overall survival and progression free survival	Evaluate the following: Response Rate after concurrent chemoradiation therapy.; Overall Survival (OS).; Progression Free Survival (PFS)		No