Positron Emission Tomography in Predicting Response in Patients Who Are Undergoing Treatment With Pemetrexed Disodium and Cisplatin With or Without Surgery for Stage I, Stage II, or Stage III Non-Small Cell Lung Cancer

University of Washington

Status and phase

Completed

Phase 2

Conditions

Lung Cancer

Treatments

Radiation: fludeoxyglucose F 18

Drug: cisplatin

Procedure: therapeutic conventional surgery

Procedure: adjuvant therapy

Drug: pemetrexed disodium

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT00227539

6228

CDR0000441239 (Registry Identifier)

LILY-UW-04033

UW-04033

P30CA015704 (U.S. NIH Grant/Contract)

UWCC-UW-6228

UWCC-6228

Details and patient eligibility

About

RATIONALE: Diagnostic procedures, such as positron emission tomography (PET), (done before, during, and after chemotherapy) may help doctors predict a patient's response to treatment and help plan the best treatment. 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 combination chemotherapy after surgery may kill any tumor cells that remain after surgery.

PURPOSE: This phase II trial is studying how well PET works in predicting response in patients who are undergoing treatment with pemetrexed disodium and cisplatin with or without surgery for stage I, stage II, or stage III non-small cell lung cancer.

Full description

OBJECTIVES:

Primary

Determine the effectiveness of fludeoxyglucose F 18 positron emission tomography in predicting radiological and pathological response in patients treated with pemetrexed disodium and cisplatin with or without surgery for stage IB-IIIB non-small cell lung cancer (NSCLC).

Secondary

Determine the safety of cisplatin and pemetrexed disodium in these patients.
Determine the radiographic response rate, duration of response, and time to progression in patients treated with cisplatin and pemetrexed disodium.

OUTLINE: This is a multicenter study.

Fludeoxyglucose F 18 (18FDG) positron emission tomography (PET) imaging: All patients undergo positron emission tomography (PET) imaging of the head, neck, thorax, abdomen, and pelvis. Patients receive fludeoxyglucose F 18 (^18FDG) IV followed by 45 minutes of rest. PET imaging is done over 1 hour and 8 minutes. Patients undergo PET imaging at three points during the study: 4 weeks prior to treatment, after the first cycle of treatment, and after 3 courses of chemotherapy. Some patients then undergo surgical resection of the tumor.
Chemotherapy: Patients receive cisplatin IV over 30 minutes and pemetrexed disodium IV over 10 minutes on day 1. Courses repeat every 21 days for up to 3 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed every 3 months for 2 years and then every 6 months for 3 years.

PROJECTED ACCRUAL: A total of 35 patients will be accrued for this study.

Enrollment

25 patients

Sex

All

Ages

18 to 120 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

DISEASE CHARACTERISTICS:

Histologically or cytologically confirmed non-small cell lung cancer (NSCLC)
Stage IB, II, IIIA, or IIIB (T4, N0-1) disease
- Staging must have been performed 4 weeks prior to study entry with a CT scan of chest, upper abdomen, and fludeoxyglucose F 18 (^18FDG) positron emission tomography (PET) scan
- Mediastinal evaluation and staging based on combination of CT scan and FDG-PET results
If N1 or N2 nodes are found by FDG-PET or CT scan, metastases must be ruled out by brain MRI
Measurable and resectable disease
- T4 lesions must be resectable
Eligible for curative surgery
No malignant pleural effusion

PATIENT CHARACTERISTICS:

Age

18 and over

Performance status

ECOG 0-1

Life expectancy

Not specified

Hematopoietic

Absolute neutrophil count ≥ 1,250/mm^3
Platelet count ≥ 100,000/mm^3

Hepatic

Bilirubin ≤ 1.5 times upper limit of normal (ULN)
AST and ALT ≤ 3.0 times ULN

Renal

Creatinine clearance ≥ 45 mL/min

Pulmonary

Adequate pulmonary reserve to undergo surgery
- Predicted FEV_1 > 0.8 L after resection

Other

Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception during and for 3 months after completion of study treatment
Able to take corticosteroids
Able to take folic acid or vitamin B_12 supplements
No other malignancy within the past 5 years except nonmelanoma skin cancer or noninvasive cervical cancer
No concurrent serious or uncontrolled disorder that would preclude study participation
No type I diabetes mellitus
- Type II diabetes mellitus allowed if glucose is 80-150 mg/dL

PRIOR CONCURRENT THERAPY:

Biologic therapy

No concurrent immunotherapy
No concurrent prophylactic filgrastim (G-CSF)
No concurrent thrombopoiesis-stimulating agents

Chemotherapy

At least 5 years since prior chemotherapy

Endocrine therapy

No concurrent anticancer hormonal therapy

Radiotherapy

No prior radiotherapy to the chest
No concurrent curative or palliative radiotherapy

Surgery

Not specified

Other

At least 30 days since prior non-FDA-approved or investigational agents
At least 5 days since prior aspirin or other nonsteroidal anti-inflammatory agents (8 days for long-acting agents [e.g., piroxicam])
No other concurrent anticancer therapy
No other concurrent investigational agents