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Study of Pemetrexed and Gemcitabine for Patients With a New Diagnosis of Extensive-Stage Small Cell Lung Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00129974
Recruitment Status : Terminated (failure to accrue)
First Posted : August 12, 2005
Results First Posted : June 16, 2017
Last Update Posted : June 16, 2017
Eli Lilly and Company
Information provided by (Responsible Party):
Tufts Medical Center

Brief Summary:
The purpose of the study is to determine whether pemetrexed and gemcitabine cause good tumour shrinkage when given to patients with previously untreated extensive-stage small cell lung cancer. The second purpose is to see if the side effects appear better than what is expected with standard chemotherapy.

Condition or disease Intervention/treatment Phase
Carcinoma, Small Cell Drug: pemetrexed and gemcitabine Phase 2

Detailed Description:
Extensive-stage small cell lung carcinoma is incurable. Present therapies are toxic and responses are short lived. This phase II, single arm, window of opportunity study will assess the response rate and toxicity of pemetrexed and gemcitabine in this cohort.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Trial of Pemetrexed in Combination With Gemcitabine as First Line Treatment in Extensive-Stage Small Cell Lung Carcinoma
Study Start Date : August 2005
Actual Primary Completion Date : October 2006
Actual Study Completion Date : October 2006

Primary Outcome Measures :
  1. Response Rate [ Time Frame: Study Termination ]
    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; Overall Response (OR) = CR + PR

Secondary Outcome Measures :
  1. Number of Participants With at Least One Adverse Event [ Time Frame: Study Termination ]
    Number of Participants with at least one Adverse Event

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Histological or cytological confirmation of extensive small cell lung cancer. For this study, extensive stage disease will be defined as including those patients whose disease cannot be encompassed in a curative radiation field. While this definition varies by treating center, it will include patients with metastatic disease to contralateral lung parenchyma or other organs (e.g. liver) and may include patients with contralateral supraclavicular, mediastinal, or hilar lymph nodes or a pleural effusion.
  • Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as >20 mm with conventional techniques or as >10 mm with spiral computed tomography (CT) scan.
  • No history of prior chemotherapy or experimental therapy for extensive or recurrent small cell lung cancer (SCLC). Subjects may have received chemotherapy as part of treatment for limited disease, but such chemotherapy must have been completed at least 6 months prior to the diagnosis of recurrent disease.
  • Prior radiation therapy is permitted if acute side effects have resolved; if the site of radiation was not the only measurable tumor site; and if less than 25% of the bone marrow was treated.
  • Age > 18 years. Because no dosing or adverse event data are currently available on the use of pemetrexed in combination with gemcitabine in patients <18 years of age, children are excluded from this study.
  • ECOG performance status 0-1.
  • Patients must have normal organ and marrow function as defined below:

    • leukocytes > 3,000/uL;
    • absolute neutrophil count > 1,500/uL;
    • platelets > 100,000/uL;
    • total bilirubin < 1.5 X institutional limits;
    • AST (SGOT)/ALT (SGPT) < 2 X institutional limits OR < 3 times the upper limit of normal in the presence of liver metastases;
    • serum sodium > 125 mEq/L and no syndrome of inappropriate antidiuretic hormone secretion (SIADH);
    • creatinine within normal institutional limits; AND
    • creatinine clearance > 45 mL/min by the Cockroft and Gault formula for patients with creatinine levels above institutional normal.
  • Brain metastases are permitted if radiation has been administered, the subject has recovered, and corticosteroids are not required.
  • The effects of pemetrexed and gemcitabine on the developing human fetus at the recommended therapeutic dose are unknown. For this reason and because anti-folate agents are known to be teratogenic, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
  • Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

  • Patients may not be receiving any other investigational agents.
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to pemetrexed or gemcitabine.
  • Pleural effusion, unless it is small, is asymptomatic, or a thoracentesis can be performed to render it small and asymptomatic prior to enrollment. Patients with significant ascites are ineligible.
  • Evidence of superior vena cava syndrome or the threat of imminent obstruction of central vessels or major airways.
  • Extensive liver involvement with tumor such that any significant degree of progression would increase the subject's risk of morbidity or mortality.
  • A major, symptomatic, paraneoplastic syndrome such as SIADH, Eaton-Lambert, Cushing's syndrome, encephalomyelitis, etc.
  • A history of prior or concurrent malignancy other than in situ carcinoma of the cervix or adequately treated basal cell carcinoma of the skin or other malignancy treated > 5 years previously without evidence of recurrence.
  • Significant comorbidity that in the judgement of the investigator would increase the subject's risk of toxicity or death while on study.
  • Pregnant women are excluded from this study because pemetrexed is an agent with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with pemetrexed or gemcitabine, breastfeeding should be discontinued if the mother is treated with either agent.
  • Candidates who are unwilling or unable to take vitamin supplementation or dexamethasone as outlined in the protocol; or who are unwilling or unable to interrupt nonsteroidal anti-inflammatories and salicylates (ASA) as outlined in the protocol.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00129974

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United States, Massachusetts
Tufts-New England Medical Center
Boston, Massachusetts, United States, 02111
Commonwealth Hematology/Oncology
Quincy, Massachusetts, United States, 02169
Baystate Medical Center
Springfield, Massachusetts, United States, 01199
Sponsors and Collaborators
Tufts Medical Center
Eli Lilly and Company
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Principal Investigator: John R Goffin, MD FRCPC Tufts Medical Center
Principal Investigator: John McCann, MD Baystate Medical Center
Principal Investigator: Walter A Kagan, MD PhD Commonwealth Hematology/Oncology
Additional Information:
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Responsible Party: Tufts Medical Center Identifier: NCT00129974    
Other Study ID Numbers: 7338
First Posted: August 12, 2005    Key Record Dates
Results First Posted: June 16, 2017
Last Update Posted: June 16, 2017
Last Verified: March 2017
Keywords provided by Tufts Medical Center:
Lung cancer
Phase II
Drug Therapy
Additional relevant MeSH terms:
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Carcinoma, Small Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Folic Acid Antagonists
Nucleic Acid Synthesis Inhibitors