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

NCT ID: NCT00227539

Last Updated: 2017-05-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-07-31
• Study Completion Date: 2013-11-30

Brief Summary

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.

Detailed 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.

Conditions

Lung Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Neoadjuvant therapy, PET scan and surgery

Group Type: EXPERIMENTAL

cisplatin

Intervention Type: DRUG

pemetrexed disodium

Intervention Type: DRUG

adjuvant therapy

Intervention Type: PROCEDURE

therapeutic conventional surgery

Intervention Type: PROCEDURE

fludeoxyglucose F 18

Intervention Type: RADIATION

Interventions

cisplatin

Intervention Type: DRUG

pemetrexed disodium

Intervention Type: DRUG

adjuvant therapy

Intervention Type: PROCEDURE

therapeutic conventional surgery

Intervention Type: PROCEDURE

fludeoxyglucose F 18

Intervention Type: RADIATION

Eligibility Criteria

Inclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 120 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

University of Washington

OTHER

Sponsor Role: lead

Responsible Party

Renato Martins

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Renato Martins, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Seattle Cancer Care Alliance

Locations

Seattle Cancer Care Alliance

Seattle, Washington, United States

University of Washington School of Medicine

Seattle, Washington, United States

Countries

United States

References

Romine PE, Martins RG, Eaton KD, Wood DE, Behnia F, Goulart BHL, Mulligan MS, Wallace SG, Kell E, Bauman JE, Patel SA, Vesselle HJ. Long term follow-up of neoadjuvant chemotherapy for non-small cell lung cancer (NSCLC) investigating early positron emission tomography (PET) scan as a predictor of outcome. BMC Cancer. 2019 Jan 14;19(1):70. doi: 10.1186/s12885-019-5284-2.

Reference Type: DERIVED

PMID: 30642285 (View on PubMed)

Other Identifiers

P30CA015704

Identifier Type: NIH

Identifier Source: secondary_id

View Link

UWCC-6228

Identifier Type: -

Identifier Source: secondary_id

UWCC-UW-6228

Identifier Type: -

Identifier Source: secondary_id

UW-04033

Identifier Type: -

Identifier Source: secondary_id

LILY-UW-04033

Identifier Type: -

Identifier Source: secondary_id

CDR0000441239

Identifier Type: REGISTRY

Identifier Source: secondary_id

6228

Identifier Type: -

Identifier Source: org_study_id