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

Lung Cancer Clinical Trial

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)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00389688
• Other study ID #: EORTC-08051
• Secondary ID: EORTC-080512005-
• Status: Terminated
• Phase: Phase 2
• First received: October 18, 2006
• Last updated: July 17, 2012
• Start date: August 2006

Study information

• Verified date: July 2012
• Source: European Organisation for Research and Treatment of Cancer - EORTC
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 13
• Est. primary completion date: July 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Cancer
• Lung Neoplasms

Intervention

Drug:
• cisplatin

• pemetrexed disodium

Procedure:
• adjuvant therapy

• conventional surgery

• neoadjuvant therapy

Locations

Country	Name	City	State
Belgium	Universitair Ziekenhuis Antwerpen	Edegem

Sponsors (1)

Lead Sponsor	Collaborator
European Organisation for Research and Treatment of Cancer - EORTC

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Successful treatment delivery			No
Primary	Toxicity (no grade 4) during chemotherapy			Yes
Secondary	Overall toxicity (all grades)			Yes
Secondary	Progression-free survival and overall survival			No
Secondary	Overall clinical response rate (neoadjuvant chemotherapy arm)			No
Secondary	Pathologic complete response (neoadjuvant chemotherapy arm)			No
Secondary	Resectability rate (neoadjuvant chemotherapy arm)			No
Secondary	Surgical morbidity and mortality			No
Secondary	Fraction of patients that actually receives chemotherapy (adjuvant chemotherapy arm)			No