Pemetrexed Disodium and Cisplatin Before or After Surgery in Treating Patients With Stage IB or Stage II Non-Small Cell Lung Cancer That Can be Removed by Surgery - Full Text View

Sponsored by:	European Organization for Research and Treatment of Cancer
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00389688

Purpose

RATIONALE: Drugs used in chemotherapy, such as pemetrexed disodium and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving combination chemotherapy after surgery may kill any tumor cells that remain after surgery. It is not yet known whether combination chemotherapy is more effective before or after surgery in treating non-small cell lung cancer.

PURPOSE: This randomized phase II trial is studying the side effects of pemetrexed disodium and cisplatin and comparing how well they work when given before or after surgery in treating patients with stage IB or stage II non-small cell lung cancer that can be removed by surgery.

Condition	Intervention	Phase
Lung Cancer	Drug: cisplatin Drug: pemetrexed disodium Procedure: adjuvant therapy Procedure: conventional surgery Procedure: neoadjuvant therapy	Phase II

MedlinePlus related topics: Cancer Lung Cancer

Drug Information available for: Cisplatin Pemetrexed disodium Pemetrexed

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label
Official Title:	Randomized Phase II Study of Pemetrexed and Cisplatin as Either Induction or Adjuvant Chemotherapy in Stage IB-II Non-Small Cell Lung Cancer (NSCLC)

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Successful treatment delivery [ Designated as safety issue: No ]
Toxicity (no grade 4) during chemotherapy [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Overall toxicity (all grades) [ Designated as safety issue: Yes ]
Progression-free survival and overall survival [ Designated as safety issue: No ]
Overall clinical response rate (neoadjuvant chemotherapy arm) [ Designated as safety issue: No ]
Pathologic complete response (neoadjuvant chemotherapy arm) [ Designated as safety issue: No ]
Resectability rate (neoadjuvant chemotherapy arm) [ Designated as safety issue: No ]
Surgical morbidity and mortality [ Designated as safety issue: No ]
Fraction of patients that actually receives chemotherapy (adjuvant chemotherapy arm) [ Designated as safety issue: No ]

Estimated Enrollment:	132
Study Start Date:	August 2006
Estimated Primary Completion Date:	December 2010 (Final data collection date for primary outcome measure)

Detailed Description:

OBJECTIVES:

Primary

Compare the tolerability (in terms of drug delivery and toxicity) of neoadjuvant vs adjuvant chemotherapy comprising cisplatin and pemetrexed disodium in patients with resectable stage IB or II non-small cell lung cancer.

Secondary

Determine the overall toxicity of this regimen in these patients.
Determine the progression-free and overall survival of patients treated with this regimen.
Determine the overall clinical response rate, pathologic complete response, and resectability rate in patients treated with neoadjuvant chemotherapy.
Determine the surgical morbidity and mortality of patients treated with these regimens.
Determine the fraction of patients in the adjuvant arm that receives chemotherapy.

OUTLINE: This is a randomized, open-label, multicenter study. Patients are stratified according to institution, histological subtype (squamous vs nonsquamous) and clinical stage (IB vs II). Patients are randomized to 1 of 2 treatment arms.

Arm I (neoadjuvant chemotherapy): Patients receive cisplatin IV over 3-6 hours and pemetrexed disodium IV on day 1. Treatment repeats every 21 days for up to 3 courses in the absence of disease progression or unacceptable toxicity. Four to six weeks after completion of chemotherapy, patients undergo surgery.
Arm II (adjuvant chemotherapy): Patients undergo surgery. Beginning 4-8 weeks after surgery, patients receive cisplatin and pemetrexed disodium as in arm I.

After completion of study treatment, patients are followed periodically for 5 years and then annually thereafter.

PROJECTED ACCRUAL: A total of 132 patients will be accrued for this study.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

DISEASE CHARACTERISTICS:

Pathologically confirmed non-small cell lung cancer (NSCLC)
- Stage IB or II disease
Resectable disease
At least 1 measurable lesion
No mediastinal involvement by mediastinoscopy and/or positron emission tomography with fludeoxyglucose F 18 scan
No evidence of metastatic disease

PATIENT CHARACTERISTICS:

WHO performance status 0-2
Absolute neutrophil count > 1,500/mm³
Platelet count > 100,000/mm³
Hemoglobin > 10 g/dL
Creatinine clearance ≥ 60 mL/min
Bilirubin ≤ 1.5 times upper limit of normal (ULN)
Alkaline phosphatase ≤ 3.0 times ULN
AST and ALT ≤ 3.0 times ULN
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception
No other malignant disease, except for the following:
- Basocellular carcinoma of the skin
- Adequately treated carcinoma in situ of the cervix
- Low-grade prostate cancer
- Other cancer for which the patient has been disease-free for ≥ 5 years
No congestive heart failure or angina pectoris unless medically controlled
No myocardial infarction within the past 6 months
No uncontrolled hypertension or arrhythmia
No active uncontrolled infection requiring antibiotics
No illness or medical condition that would preclude study participation
No pre-existing motor or sensory neurotoxicity ≥ grade 2

PRIOR CONCURRENT THERAPY:

No prior surgery for NSCLC
No prior or other concurrent chemotherapy for NSCLC
No prior or concurrent radiotherapy for NSCLC
No concurrent immunotherapy
No concurrent targeted agents
No concurrent hormonal cancer therapy
No concurrent routine colony-stimulating factor (e.g., prophylactic filgrastim [G-CSF])
No aspirin or nonsteroidal anti-inflammatory drugs within 5 days before or after chemotherapy
No other concurrent experimental treatments
No other concurrent anticancer treatments

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00389688

Locations

Belgium
Universitair Ziekenhuis Antwerpen
Edegem, Belgium, B-2650

Sponsors and Collaborators

European Organization for Research and Treatment of Cancer

Investigators

Study Chair:

Paul Germonpre, MD

Universitair Ziekenhuis Antwerpen

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Study ID Numbers:	CDR0000508880, EORTC-08051, EUDRACT-2005-003822-25
Study First Received:	October 18, 2006
Last Updated:	July 29, 2008
ClinicalTrials.gov Identifier:	NCT00389688
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

stage I non-small cell lung cancer
stage II non-small cell lung cancer

Study placed in the following topic categories:

Folic Acid
Pemetrexed
Thoracic Neoplasms
Non-small cell lung cancer
Cisplatin
Respiratory Tract Diseases

Lung Neoplasms
Lung Diseases
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial
Carcinoma

Additional relevant MeSH terms:

Antimetabolites
Respiratory Tract Neoplasms
Neoplasms by Histologic Type
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Physiological Effects of Drugs

Enzyme Inhibitors
Folic Acid Antagonists
Pharmacologic Actions
Neoplasms
Neoplasms by Site
Radiation-Sensitizing Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on January 16, 2009