A Phase II Trial of Pemetrexed in Combination With Gemcitabine as First Line Treatment in Extensive-Stage Small Cell Lung Carcinoma

Tufts Medical Center3 sites in 1 country1 target enrollmentAugust 2005

ConditionsCarcinoma, Small Cell

Drugspemetrexed and gemcitabine

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Carcinoma, Small Cell
Sponsor: Tufts Medical Center
Enrollment: 1
Locations: 3
Primary Endpoint: Response Rate
Status: Terminated
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

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.

Registry

clinicaltrials.gov

Start Date

August 2005

End Date

October 2006

Last Updated

8 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Tufts Medical Center

Responsible Party

Sponsor

Eligibility Criteria

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-
•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;

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.

Outcomes

Primary Outcomes

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