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Cisplatin and Pemetrexed With Radiation Followed by Lobectomy (CisPemXetSrg)

Primary Purpose

Nonsquamous Nonsmall Cell Neoplasm of Lung, Nonsmall Cell Lung Cancer Stage III

Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Pemetrexed
Carboplatin
Radiation Therapy
Pemetrexed
Cisplatin
Radiation Therapy
Lobectomy
Lobectomy
Sponsored by
Medical University of South Carolina
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Nonsquamous Nonsmall Cell Neoplasm of Lung focused on measuring resectable

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Medical University of South Carolina

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Arm A

Arm B

Arm Description

Patients will be given the drugs pemetrexed and carboplatin Radiation Participants evaluated for response Lobectomy surgery

Patients will be given the drugs pemetrexed and cisplatin Radiation Participants evaluated for response Lobectomy surgery

Outcomes

Primary Outcome Measures

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

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

Full Information

First Posted
June 13, 2011
Last Updated
July 24, 2012
Sponsor
Medical University of South Carolina
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1. Study Identification

Unique Protocol Identification Number
NCT01373463
Brief Title
Cisplatin and Pemetrexed With Radiation Followed by Lobectomy
Acronym
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)
Study Type
Interventional

2. Study Status

Record Verification Date
July 2012
Overall Recruitment Status
Terminated
Why Stopped
Investigator left site
Study Start Date
May 2011 (undefined)
Primary Completion Date
June 2012 (Actual)
Study Completion Date
June 2012 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Medical University of South Carolina

4. Oversight

Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nonsquamous Nonsmall Cell Neoplasm of Lung, Nonsmall Cell Lung Cancer Stage III
Keywords
resectable

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
48 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm A
Arm Type
Experimental
Arm Description
Patients will be given the drugs pemetrexed and carboplatin Radiation Participants evaluated for response Lobectomy surgery
Arm Title
Arm B
Arm Type
Experimental
Arm Description
Patients will be given the drugs pemetrexed and cisplatin Radiation Participants evaluated for response Lobectomy surgery
Intervention Type
Drug
Intervention Name(s)
Pemetrexed
Intervention Description
Pemetrexed by vein every 21 days for 3 cycles
Intervention Type
Drug
Intervention Name(s)
Carboplatin
Intervention Description
Carboplatin by vein Every 21 days for 3 cycles
Intervention Type
Radiation
Intervention Name(s)
Radiation Therapy
Intervention Description
Radiation treatment 5 days a week for 5-6 weeks.
Intervention Type
Drug
Intervention Name(s)
Pemetrexed
Intervention Description
Pemetrexed by vein every 21 days for 3 cycles
Intervention Type
Drug
Intervention Name(s)
Cisplatin
Intervention Description
Cisplatin by vein every 21 days for 3 cycles
Intervention Type
Radiation
Intervention Name(s)
Radiation Therapy
Intervention Description
Radiation treatment 5 days a week for 5-6 weeks.
Intervention Type
Procedure
Intervention Name(s)
Lobectomy
Intervention Description
Surgery
Intervention Type
Procedure
Intervention Name(s)
Lobectomy
Intervention Description
Surgery to remove a portion of the lung where the tumor is located.
Primary Outcome Measure Information:
Title
Safety and tolerability
Description
Determine the safety and tolerability of concurrent chemotherapy with Cisplatin/ Pemetrexed or Carboplatin/Pemetrexed and dose escalated radiation therapy followed by lobectomy.
Secondary Outcome Measure Information:
Title
Response rate, overall survival and progression free survival
Description
Evaluate the following: Response Rate after concurrent chemoradiation therapy. Overall Survival (OS). Progression Free Survival (PFS)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States

12. IPD Sharing Statement

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Cisplatin and Pemetrexed With Radiation Followed by Lobectomy

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