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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

Primary Purpose

Lung Cancer

Status

Terminated

Phase

Phase 2

Locations

Belgium

Study Type

Interventional

Intervention

cisplatin

pemetrexed disodium

adjuvant therapy

conventional surgery

neoadjuvant therapy

About this trial

This is an interventional treatment trial for Lung Cancer focused on measuring stage I non-small cell lung cancer, stage II non-small cell lung cancer

Eligibility Criteria

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

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

Sites / Locations

Universitair Ziekenhuis Antwerpen

Outcomes

Primary Outcome Measures

Successful treatment delivery

Toxicity (no grade 4) during chemotherapy

Secondary Outcome Measures

Overall toxicity (all grades)

Progression-free survival and overall survival

Overall clinical response rate (neoadjuvant chemotherapy arm)

Pathologic complete response (neoadjuvant chemotherapy arm)

Resectability rate (neoadjuvant chemotherapy arm)

Surgical morbidity and mortality

Fraction of patients that actually receives chemotherapy (adjuvant chemotherapy arm)

Full Information

NCT ID

NCT00389688

First Posted

October 18, 2006

Last Updated

July 17, 2012

Sponsor

European Organisation for Research and Treatment of Cancer - EORTC

1. Study Identification

Unique Protocol Identification Number

NCT00389688

Brief Title

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

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)

Study Type

Interventional

2. Study Status

Record Verification Date

July 2012

Overall Recruitment Status

Terminated

Why Stopped

low accrual

Study Start Date

August 2006 (undefined)

Primary Completion Date

July 2008 (Actual)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

European Organisation for Research and Treatment of Cancer - EORTC

4. Oversight

5. Study Description

Brief 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Lung Cancer

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Masking

None (Open Label)

Allocation

Randomized

Enrollment

13 (Actual)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

cisplatin

Intervention Type

Drug

Intervention Name(s)

pemetrexed disodium

Intervention Type

Procedure

Intervention Name(s)

adjuvant therapy

Intervention Type

Procedure

Intervention Name(s)

conventional surgery

Intervention Type

Procedure

Intervention Name(s)

neoadjuvant therapy

Primary Outcome Measure Information:

Title

Successful treatment delivery

Title

Toxicity (no grade 4) during chemotherapy

Secondary Outcome Measure Information:

Title

Overall toxicity (all grades)

Title

Progression-free survival and overall survival

Title

Overall clinical response rate (neoadjuvant chemotherapy arm)

Title

Pathologic complete response (neoadjuvant chemotherapy arm)

Title

Resectability rate (neoadjuvant chemotherapy arm)

Title

Surgical morbidity and mortality

Title

Fraction of patients that actually receives chemotherapy (adjuvant chemotherapy arm)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Paul Germonpre, MD

Organizational Affiliation

University Hospital, Antwerp

Official's Role

Study Chair

Facility Information:

Facility Name

Universitair Ziekenhuis Antwerpen

City

Edegem

ZIP/Postal Code

B-2650

Country

Belgium

12. IPD Sharing Statement

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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

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