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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)


Phase 1
18 Years
90 Years
Not Enrolling
Both
Nonsquamous Nonsmall Cell Neoplasm of Lung, Nonsmall Cell Lung Cancer Stage III

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Trial Information

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)


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.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Safety and tolerability

Outcome Description:

Determine the safety and tolerability of concurrent chemotherapy with Cisplatin/ Pemetrexed or Carboplatin/Pemetrexed and dose escalated radiation therapy followed by lobectomy.

Safety Issue:

Yes

Authority:

United States: Institutional Review Board

Study ID:

101466

NCT ID:

NCT01373463

Start Date:

May 2011

Completion Date:

June 2012

Related Keywords:

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

Name

Location

Medical University of South Carolina Charleston, South Carolina  29425-0721