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

Phase 2

Completed

• Conditions: Lung Cancer
• Interventions: Drug: cisplatin; Drug: pemetrexed disodium; Procedure: adjuvant therapy; Procedure: therapeutic conventional surgery; Radiation: fludeoxyglucose F 18

• Registration Number: NCT00227539
• Lead Sponsor: University of Washington

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.

Study Timeline

• Study Start: 2005-07
• Study First Submitted: 2005-09-26
• Study First Submitted QC: 2005-09-26
• Study First Posted: 2005-09-28
• Primary Completion: 2010-03
• Study Completion: 2013-11
• Status Verified: 2017-02
• Results First Submitted: 2017-02-14
• Results First Submitted QC: 2017-02-14
• Last Update Submitted: 2017-03-31
• Results First Posted: 2017-04-04
• Last Update Posted: 2017-05-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Neoadjuvant therapy, PET scan and surgery	pemetrexed disodium	-
Neoadjuvant therapy, PET scan and surgery	adjuvant therapy	-
Neoadjuvant therapy, PET scan and surgery	therapeutic conventional surgery	-
Neoadjuvant therapy, PET scan and surgery	fludeoxyglucose F 18	-
Neoadjuvant therapy, PET scan and surgery	cisplatin	-

Primary Outcome Measures

Name	Time	Method
Positron Emission Tomography as a Predictor of Response Measured by the Decrease in Standard Uptake Variable (SUV) After 1 Course of Therapy	Between days 18 and 22 prior to second chemotherapy infusion	Number of Participants with Decrease in Standard Uptake Variable (SUV) After 1 Course of Therapy

Secondary Outcome Measures

Name	Time	Method
Safety of Neoadjuvant Chemotherapy	Up to 4 weeks after last dose of chemotherapy	The number of patients that experienced a grade 3 or higher adverse event.
Efficacy of Neoadjuvant Chemotherapy as Measured by Radiologic Response Rate	Up to 4 weeks after last dose of chemotherapy	The number of patients that had either a CR, PR or SD after the completion of chemotherapy. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Progression, as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions; Stable Disease (SD), neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for disease progression.

Trial Locations

Locations (2)

Seattle Cancer Care Alliance; 🇺🇸 Seattle, Washington, United States

University of Washington School of Medicine; 🇺🇸 Seattle, Washington, United States