Pemetrexed Disodium Plus Gemcitabine in Treating Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer

NCT00022646 | Completed Phase 2 DMC

• 3 other identifiers: NCCTG-N0026NCI-2012-02399CDR0000068838
• Study Type: interventional
• Target: 157
• Locations: 1 country
• Sites: 22

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Giving more than one drug and giving the drugs in different ways may kill more tumor cells. PURPOSE: Randomized phase II trial to compare the effectiveness of three different regimens of pemetrexed disodium plus gemcitabine in treating patients who have locally advanced or metastatic non-small cell lung cancer.

Conditions

Lung Cancer

Keywords

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

Outcome Measures

Primary Outcomes (1)

• tumor response rate

  Up to 4 years

Secondary Outcomes (4)

• duration of response

  Up to 4 years

• time to treatment failure

  Up to 4 years

• survival

  Up to 4 years

• time to disease progression

  Up to 4 years

Study Arms (3)

Arm I: pemetrexed + gemcitabine

EXPERIMENTAL

Patients receive pemetrexed disodium IV over 10 minutes on day 1 followed by gemcitabine IV over 30 minutes on days 1 and 8.

Drug: gemcitabine hydrochloride; Drug: pemetrexed disodium

Arm II: pemetrexed + gemcitabine

EXPERIMENTAL

Patients receive gemcitabine IV over 30 minutes on days 1 and 8 followed by pemetrexed disodium IV over 10 minutes on day 1.

Drug: gemcitabine hydrochloride; Drug: pemetrexed disodium

Arm III: pemetrexed + gemcitabine

EXPERIMENTAL

Patients receive gemcitabine IV over 30 minutes on day 1 and pemetrexed disodium IV over 10 minutes followed by gemcitabine IV over 30 minutes on day 8.

Drug: gemcitabine hydrochloride; Drug: pemetrexed disodium

Interventions

gemcitabine hydrochloride DRUG

Arm I: pemetrexed + gemcitabine; Arm II: pemetrexed + gemcitabine; Arm III: pemetrexed + gemcitabine

pemetrexed disodium DRUG

Arm I: pemetrexed + gemcitabine; Arm II: pemetrexed + gemcitabine; Arm III: pemetrexed + gemcitabine

Eligibility Criteria

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

DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed locally advanced or metastatic non-small cell lung cancer * Stage IIIB disease that is ineligible for combined modality therapy OR * Stage IV disease * Measurable disease * No clinically detectable (by physical exam) third-space fluid collection (e.g., ascites or pleural effusions) that cannot be controlled by drainage or other procedures * No brain metastases (even if treated) PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * ECOG 0-1 Life expectancy: * At least 12 weeks Hematopoietic: * Absolute neutrophil count at least 1,500/mm\^3 * Platelet count at least 100,000/mm\^3 * Hemoglobin at least 9 g/dL Hepatic: * Bilirubin no greater than 1.5 times upper limit of normal (ULN) * AST and ALT no greater than 3 times ULN (5 times ULN if liver metastases present) * Alkaline phosphatase no greater than 3 times ULN (5 times ULN if liver metastases present) Renal: * Creatinine clearance at least 45 mL/min Other: * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * Able to take folic acid or cyanocobalamin (vitamin B12) supplementation * No uncontrolled infection * No concurrent chronic debilitating disease * No weight loss of 10% or more within the past 6 weeks * No other prior malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or noninvasive carcinoma PRIOR CONCURRENT THERAPY: Biologic therapy: * No prior biologic or genetic therapy for lung cancer * No concurrent immunomodulating agents Chemotherapy: * No prior chemotherapy for lung cancer Endocrine therapy: * Not specified Radiotherapy: * At least 4 weeks since prior radiotherapy to a different site and recovered * No prior radiotherapy to 25% or more of bone marrow * No prior radiotherapy to whole pelvis * No prior radiotherapy for primary disease * No concurrent radiotherapy Surgery: * More than 4 weeks since prior major surgery Other: * No aspirin or nonsteroidal anti-inflammatory agents 2 days before, during, and for 2 days after pemetrexed disodium administration (5 days for long-acting agents such as piroxicam, naproxen, diflunisal, or nabumetone) * No other concurrent cytostatic or cytotoxic therapy

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

Sponsors & Collaborators

• Alliance for Clinical Trials in Oncology: lead
• National Cancer Institute (NCI): collaborator

Study Sites (22)

CCOP - Scottsdale Oncology Program

Scottsdale, Arizona, 85259-5404, United States

Location

Mayo Clinic

Jacksonville, Florida, 32224, United States

Location

CCOP - Illinois Oncology Research Association

Peoria, Illinois, 61602, United States

Location

CCOP - Carle Cancer Center

Urbana, Illinois, 61801, United States

Location

CCOP - Cedar Rapids Oncology Project

Cedar Rapids, Iowa, 52403-1206, United States

Location

CCOP - Iowa Oncology Research Association

Des Moines, Iowa, 50309-1016, United States

Location

Siouxland Hematology-Oncology

Sioux City, Iowa, 51101-1733, United States

Location

CCOP - Wichita

Wichita, Kansas, 67214-3882, United States

Location

CCOP - Ann Arbor Regional

Ann Arbor, Michigan, 48106, United States

Location

CCOP - Duluth

Duluth, Minnesota, 55805, United States

Location

Mayo Clinic Cancer Center

Rochester, Minnesota, 55905, United States

Location

CentraCare Health Plaza

Saint Cloud, Minnesota, 56303, United States

Location

CCOP - Metro-Minnesota

Saint Louis Park, Minnesota, 55416, United States

Location

CCOP - Missouri Valley Cancer Consortium

Omaha, Nebraska, 68106, United States

Location

Medcenter One Health System

Bismarck, North Dakota, 58501, United States

Location

CCOP - Merit Care Hospital

Fargo, North Dakota, 58122, United States

Location

Altru Health Systems

Grand Forks, North Dakota, 58201, United States

Location

CCOP - Toledo Community Hospital

Toledo, Ohio, 43623-3456, United States

Location

CCOP - Geisinger Clinic and Medical Center

Danville, Pennsylvania, 17822-2001, United States

Location

Allegheny General Hospital

Pittsburgh, Pennsylvania, 15212-4772, United States

Location

Rapid City Regional Hospital

Rapid City, South Dakota, 57709, United States

Location

CCOP - Sioux Community Cancer Consortium

Sioux Falls, South Dakota, 57104, United States

Location

Related Publications (5)

• An MW, Mandrekar SJ, Branda ME, Hillman SL, Adjei AA, Pitot HC, Goldberg RM, Sargent DJ. Comparison of continuous versus categorical tumor measurement-based metrics to predict overall survival in cancer treatment trials. Clin Cancer Res. 2011 Oct 15;17(20):6592-9. doi: 10.1158/1078-0432.CCR-11-0822. Epub 2011 Aug 31.

  PMID: 21880789 BACKGROUND

• Campbell ME, Mandrekar SJ, Hillman SL, et al.: What is the added value of actual tumor measurements (TM) in predicting overall survival (OS)? The North Central Cancer Treatment Group (NCCTG) findings. [Abstract] J Clin Oncol 26 (Suppl 15): A-6520, 2008.

  BACKGROUND

• Jatoi A, Hillman S, Stella P, Green E, Adjei A, Nair S, Perez E, Amin B, Schild SE, Castillo R, Jett JR; North Central Cancer Treatment Group. Should elderly non-small-cell lung cancer patients be offered elderly-specific trials? Results of a pooled analysis from the North Central Cancer Treatment Group. J Clin Oncol. 2005 Dec 20;23(36):9113-9. doi: 10.1200/JCO.2005.03.7465.

  PMID: 16361618 BACKGROUND

• Adjei AA, Salavaggione OE, Mandrekar SJ, Dy GK, Ziegler KL, Endo C, Molina JR, Schild SE, Adjei AA. Correlation between polymorphisms of the reduced folate carrier gene (SLC19A1) and survival after pemetrexed-based therapy in non-small cell lung cancer: a North Central Cancer Treatment Group-based exploratory study. J Thorac Oncol. 2010 Sep;5(9):1346-53. doi: 10.1097/JTO.0b013e3181ec18c4.

  PMID: 20651609 RESULT

• Ma CX, Nair S, Thomas S, Mandrekar SJ, Nikcevich DA, Rowland KM, Fitch TR, Windschitl HE, Hillman SL, Schild SE, Jett JR, Obasaju C, Adjei AA; North Central Cancer Treatment Group; Mayo Clinic; Eli Lilly & Company. Randomized phase II trial of three schedules of pemetrexed and gemcitabine as front-line therapy for advanced non-small-cell lung cancer. J Clin Oncol. 2005 Sep 1;23(25):5929-37. doi: 10.1200/JCO.2005.13.953.

  PMID: 16135464 RESULT

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

Study Officials

• Alex A. Adjei, MD, PhD

  Mayo Clinic

  STUDY CHAIR

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: August 10, 2001
• First Posted: January 27, 2003
• Study Start: August 1, 2001
• Primary Completion: November 1, 2003
• Study Completion: October 1, 2008
• Last Updated: December 7, 2016

Record last verified: 2016-12

Locations

US (22)