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

NCT00129974 | Terminated Phase 2 Results

• 1 other identifier: 7338
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 3

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.

Conditions

Carcinoma, Small Cell

Keywords

Lung cancer; Phase II; Drug Therapy

Outcome Measures

Primary Outcomes (1)

• Response Rate

  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

  Study Termination

Secondary Outcomes (1)

• Number of Participants With at Least One Adverse Event

  Study Termination

Interventions

pemetrexed and gemcitabine DRUG

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tufts Medical Center: lead
• Eli Lilly and Company: collaborator

Study Sites (3)

Tufts-New England Medical Center

Boston, Massachusetts, 02111, United States

Location

Commonwealth Hematology/Oncology

Quincy, Massachusetts, 02169, United States

Location

Baystate Medical Center

Springfield, Massachusetts, 01199, United States

Location

Related Links

• Baystate Cancer Center

MeSH Terms

Conditions

Carcinoma, Small Cell; Lung Neoplasms

Interventions

Pemetrexed; Gemcitabine

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

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; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring

Results Point of Contact

• Title: Research Administration
• Organization: Tufts Medical Center

mcoughlin@tuftsmedicalcenter.org

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

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

Study Record Dates

• First Submitted: August 10, 2005
• First Posted: August 12, 2005
• Study Start: August 1, 2005
• Primary Completion: October 1, 2006
• Study Completion: October 1, 2006
• Last Updated: June 16, 2017
• Results First Posted: June 16, 2017

Record last verified: 2017-03

Locations

US (3)