Pemetrexed Disodium and Gemcitabine in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer

NCT00407550 | Completed Phase 2 Results DMC

• 5 other identifiers: CDR0000516012P30CA015083RC052406-002282H3E-US-S061
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: Pemetrexed disodium may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as gemcitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving pemetrexed disodium together with gemcitabine may kill more tumor cells. PURPOSE: This randomized phase II trial is studying two different schedules of pemetrexed disodium and gemcitabine to compare how well they work in treating patients with stage IIIB or stage IV non-small cell lung cancer.

Conditions

Lung Cancer

Keywords

stage IIIB non-small cell lung cancer; stage IV non-small cell lung cancer; recurrent non-small cell lung cancer

Outcome Measures

Primary Outcomes (1)

• Number of Patients With Confirmed Responses

  Confirmed tumor response (complete and partial) as measured by RECIST(Response Evaluation Criteria In Solid Tumors) criteria on 2 consecutive evaluations at least 6 weeks apart. \> \> Confirmed tumor response is at least a 30% decrease in the sum of the longest diameter of target lesions and no new lesions.

  Two consecutive evaluations at least 6 weeks apart (up to 2 years)

Secondary Outcomes (3)

• Progression-free Survival

  Time from registration to progression or death (up to 2 years)

• Overall Survival

  Death or last follow-up (up to 2 years)

• Adverse Event

  Gemzar x2 Arm every 21 days, Gemzar x1 Arm every 14 days (up to 2 years)

Study Arms (2)

Gemzar x2

EXPERIMENTAL

Treat subjects with 2 dosings/cycle of Gemzar x6 cycles.

Drug: gemcitabine HCL; Drug: pemetrexed disodium

Gemzar x1

EXPERIMENTAL

Treat subjects with 1 dosing/cycle of Gemzar x9 cycles.

Drug: pemetrexed disodium; Drug: gemcitabine HCL

Interventions

gemcitabine HCL DRUG

1250 mg/m\^2 administered through 250 cc NS (normal saline) IV (intravenous) infusion over 30 minutes at days 1 \& 8 of each cycle (21 days) x6 cycles.

Also known as: GEMZAR

Gemzar x2

pemetrexed disodium DRUG

500 mg/m\^2 administered through 100 mL NS IV infusion over 10 minutes at day 1 of each cycle.

Also known as: ALIMTA

Gemzar x1; Gemzar x2

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 IIIB (with controlled pleural effusion) OR stage IV disease * At least 1 measurable lesion whose longest diameter is ≥ 20 mm by conventional techniques OR ≥ 10 mm by spiral CT scan * No medically significant third-space fluid collection (e.g., ascites or pleural effusions) that cannot be controlled by drainage or other procedures * No documented brain metastases unless all of the following criteria are met: * Successful local therapy has been completed * At least 2 weeks since prior corticosteroids * Brain imaging required for symptomatic patients only (to rule out brain metastases) * Concurrent enrollment in clinical trial MCCRC-RC0527 required PATIENT CHARACTERISTICS: * Life expectancy ≥ 12 weeks * ECOG performance status 0-1 * Absolute neutrophil count ≥ 1,500/mm³ * Platelet count ≥ 100,000/mm³ * Hemoglobin ≥ 9.0 g/dL * Bilirubin ≤ 1.5 times upper limit of normal (ULN) * Alkaline phosphatase ≤ 3 times ULN * AST and ALT ≤ 3 times ULN (5 times ULN for liver involvement) * Creatinine clearance ≥ 45 mL/min * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * Able to take folic acid, cyanocobalamin (vitamin B12) supplementation, or dexamethasone and corticosteroids * Able to interrupt intake of aspirin and nonsteroidal anti-inflammatory agents for a total of 5 days * No severe and/or uncontrolled medical conditions, including any of the following: * Hypertension, labile hypertension, or history of poor compliance with antihypertensive medication * Angina pectoris * Congestive heart failure within the past 3 months, unless ejection fraction \> 40% * Myocardial infarction within the past 6 months * Cardiac arrhythmia * Diabetes * Interstitial pneumonia or extensive and symptomatic interstitial fibrosis of the lung * New York Heart Association class III or IV heart disease * Clinically significant infection * No other serious medical condition or illness that would preclude study participation * No peripheral neuropathy ≥ grade 2 * No other malignancy within the past 5 years except nonmelanomatous skin cancer, carcinoma in situ of the cervix, or low-grade (Gleason score ≤ 6) localized prostate cancer * No significant weight loss (≥ 10%) within the past 6 weeks * No investigator site personnel directly affiliated with the study, or immediate family (i.e., spouse, parent, child, or sibling, whether biological or legally adopted) * No employees of Eli Lilly (i.e., employees, temporary contract workers, or designees responsible for conducting the study) * Immediate family of Eli Lilly employees may participate in Eli Lilly-sponsored clinical trials, but are not permitted to participate at an Eli Lilly facility PRIOR CONCURRENT THERAPY: * See Disease Characteristics * At least 2 weeks since prior corticosteroids * At least 4 weeks since prior radiation therapy involving \> 25% of the bone marrow and recovered * At least 30 days since prior investigational therapy * No prior radiation therapy to the whole pelvis * No prior systemic chemotherapy for advanced non-small cell lung cancer * No prior pemetrexed disodium and/or gemcitabine hydrochloride * No prior or concurrent sorafenib tosylate and/or temsirolimus * No concurrent Hypericum perforatum (St. John's wort) * No other concurrent antitumor therapy * No concurrent agents that stimulate thrombopoiesis * Concurrent palliative radiation therapy allowed * Concurrent corticosteroids allowed for adrenal insufficiency or severe nausea and vomiting

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

Sponsors & Collaborators

• Mayo Clinic: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Mayo Clinic Cancer Center

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Lung Neoplasms; Carcinoma, Non-Small-Cell Lung

Interventions

Gemcitabine; Pemetrexed

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Dicarboxylic

Results Point of Contact

• Title: Julian R. Molina, M.D., Ph.D.
• Organization: Mayo Clinic

molina.julian@mayo.edu

507-284-8318

Study Officials

• Julian Molina, MD, PhD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 4, 2006
• First Posted: December 5, 2006
• Study Start: November 1, 2006
• Primary Completion: January 1, 2008
• Study Completion: May 12, 2010
• Last Updated: May 2, 2019
• Results First Posted: June 13, 2012

Record last verified: 2016-04

Locations

US (1)