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

NCT00227539 | Completed Phase 2 Results

• 7 other identifiers: 6228P30CA015704UWCC-6228UWCC-UW-6228UW-04033LILY-UW-04033CDR0000441239
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 2

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.

Conditions

Lung Cancer

Keywords

stage I non-small cell lung cancer; stage II non-small cell lung cancer; stage IIIA non-small cell lung cancer; stage IIIB non-small cell lung cancer

Outcome Measures

Primary Outcomes (1)

• Positron Emission Tomography as a Predictor of Response Measured by the Decrease in Standard Uptake Variable (SUV) After 1 Course of Therapy

  Number of Participants with Decrease in Standard Uptake Variable (SUV) After 1 Course of Therapy

  Between days 18 and 22 prior to second chemotherapy infusion

Secondary Outcomes (2)

• Safety of Neoadjuvant Chemotherapy

  Up to 4 weeks after last dose of chemotherapy

• Efficacy of Neoadjuvant Chemotherapy as Measured by Radiologic Response Rate

  Up to 4 weeks after last dose of chemotherapy

Study Arms (1)

Neoadjuvant therapy, PET scan and surgery

EXPERIMENTAL

Drug: cisplatin; Drug: pemetrexed disodium; Procedure: adjuvant therapy; Procedure: therapeutic conventional surgery; Radiation: fludeoxyglucose F 18

Interventions

cisplatin DRUG

Neoadjuvant therapy, PET scan and surgery

pemetrexed disodium DRUG

Neoadjuvant therapy, PET scan and surgery

adjuvant therapy PROCEDURE

Neoadjuvant therapy, PET scan and surgery

therapeutic conventional surgery PROCEDURE

Neoadjuvant therapy, PET scan and surgery

fludeoxyglucose F 18 RADIATION

Neoadjuvant therapy, PET scan and surgery

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• University of Washington: lead
• National Cancer Institute (NCI): collaborator

Study Sites (2)

Seattle Cancer Care Alliance

Seattle, Washington, 98109-1023, United States

Location

University of Washington School of Medicine

Seattle, Washington, 98195, United States

Location

Related Publications (1)

• 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.

  PMID: 30642285 DERIVED

MeSH Terms

Conditions

Lung Neoplasms; Carcinoma, Non-Small-Cell Lung

Interventions

Cisplatin; Pemetrexed; Chemotherapy, Adjuvant; Fluorodeoxyglucose F18

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Dicarboxylic; Combined Modality Therapy; Therapeutics; Drug Therapy; Deoxyglucose; Deoxy Sugars; Carbohydrates

Results Point of Contact

• Title: Renato G. Martins
• Organization: University of Washington

rgmart@uw.edu

206-288-6680

Study Officials

• Renato Martins, MD, MPH

  Seattle Cancer Care Alliance

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 26, 2005
• First Posted: September 28, 2005
• Study Start: July 1, 2005
• Primary Completion: March 1, 2010
• Study Completion: November 1, 2013
• Last Updated: May 9, 2017
• Results First Posted: April 4, 2017

Record last verified: 2017-02

Locations

US (2)