Study of Pemetrexed and Gemcitabine for Patients With a New Diagnosis of Extensive-Stage Small Cell Lung Cancer
Study Details
Study Description
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 |
|---|---|---|
|
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.
Study Design
Outcome Measures
Primary Outcome Measures
- Response Rate [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
- Number of Participants With at Least One Adverse Event [Study Termination]
Number of Participants with at least one Adverse Event
Eligibility Criteria
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.
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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.
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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.
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ECOG performance status 0-1.
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Patients must have normal organ and marrow function as defined below:
-
leukocytes > 3,000/uL;
-
absolute neutrophil count > 1,500/uL;
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platelets > 100,000/uL;
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total bilirubin < 1.5 X institutional limits;
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AST (SGOT)/ALT (SGPT) < 2 X institutional limits OR < 3 times the upper limit of normal in the presence of liver metastases;
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serum sodium > 125 mEq/L and no syndrome of inappropriate antidiuretic hormone secretion (SIADH);
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creatinine within normal institutional limits; AND
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creatinine clearance > 45 mL/min by the Cockroft and Gault formula for patients with creatinine levels above institutional normal.
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Brain metastases are permitted if radiation has been administered, the subject has recovered, and corticosteroids are not required.
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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.
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Ability to understand and the willingness to sign a written informed consent document.
Exclusion Criteria:
-
Patients may not be receiving any other investigational agents.
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History of allergic reactions attributed to compounds of similar chemical or biologic composition to pemetrexed or gemcitabine.
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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.
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Evidence of superior vena cava syndrome or the threat of imminent obstruction of central vessels or major airways.
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Extensive liver involvement with tumor such that any significant degree of progression would increase the subject's risk of morbidity or mortality.
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A major, symptomatic, paraneoplastic syndrome such as SIADH, Eaton-Lambert, Cushing's syndrome, encephalomyelitis, etc.
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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.
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Significant comorbidity that in the judgement of the investigator would increase the subject's risk of toxicity or death while on study.
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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.
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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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Tufts-New England Medical Center | Boston | Massachusetts | United States | 02111 |
| 2 | Commonwealth Hematology/Oncology | Quincy | Massachusetts | United States | 02169 |
| 3 | Baystate Medical Center | Springfield | Massachusetts | United States | 01199 |
Sponsors and Collaborators
- Tufts Medical Center
- Eli Lilly and Company
Investigators
- 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
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- 7338
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Arm 1 |
|---|---|
| Arm/Group Description | Pemetrexed and Gemcitabine |
| Period Title: Overall Study | |
| STARTED | 1 |
| COMPLETED | 0 |
| NOT COMPLETED | 1 |
Baseline Characteristics
| Arm/Group Title | Arm 1 |
|---|---|
| Arm/Group Description | Pemetrexed and Gemcitabine |
| Overall Participants | 1 |
| Age (Count of Participants) | |
| <=18 years |
0
0%
|
| Between 18 and 65 years |
1
100%
|
| >=65 years |
0
0%
|
| Sex: Female, Male (Count of Participants) | |
| Female |
0
0%
|
| Male |
1
100%
|
| Region of Enrollment (participants) [Number] | |
| United States |
1
100%
|
Outcome Measures
| Title | Response Rate |
|---|---|
| Description | 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 |
| Time Frame | Study Termination |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Arm 1 |
|---|---|
| Arm/Group Description | Pemetrexed and Gemcitabine |
| Measure Participants | 0 |
| Title | Number of Participants With at Least One Adverse Event |
|---|---|
| Description | Number of Participants with at least one Adverse Event |
| Time Frame | Study Termination |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Arm 1 |
|---|---|
| Arm/Group Description | Pemetrexed and Gemcitabine |
| Measure Participants | 0 |
Adverse Events
| Time Frame | ||
|---|---|---|
| Adverse Event Reporting Description | ||
| Arm/Group Title | Arm 1 | |
| Arm/Group Description | ||
All Cause Mortality |
||
| Arm 1 | ||
| Affected / at Risk (%) | # Events | |
| Total | / (NaN) | |
Serious Adverse Events |
||
| Arm 1 | ||
| Affected / at Risk (%) | # Events | |
| Total | 0/1 (0%) | |
Other (Not Including Serious) Adverse Events |
||
| Arm 1 | ||
| Affected / at Risk (%) | # Events | |
| Total | 0/1 (0%) | |
Limitations/Caveats
More Information
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Research Administration |
|---|---|
| Organization | Tufts Medical Center |
| Phone | |
| mcoughlin@tuftsmedicalcenter.org |
- 7338