Carcinoma, Small CellPhase 2NCT00129974
Study of Pemetrexed and Gemcitabine for Patients With a New Diagnosis of Extensive-Stage Small Cell Lung Cancer
A Phase 2 study testing pemetrexed and gemcitabine in people with Carcinoma, Small Cell, run by Tufts Medical Center at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carcinoma, Small Cell
- What is being tested?
- pemetrexed and gemcitabine
- How many people
- 1 participants
- Where
- 3 sitesUnited States
- Study dates
- Aug 2005to Oct 2006
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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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;
- 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.
Who cannot join
- 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.
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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.
- 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.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Tufts-New England Medical Center
Boston, Massachusetts, 02111
Commonwealth Hematology/Oncology
Quincy, Massachusetts, 02169
Baystate Medical Center
Springfield, Massachusetts, 01199
About this study
Official title: A Phase II Trial of Pemetrexed in Combination With Gemcitabine as First Line Treatment in Extensive-Stage Small Cell Lung Carcinoma
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.
Read the 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.
- Conditions
- Carcinoma, Small Cell
- Being tested
- pemetrexed and gemcitabine
- Keywords
- Lung cancer, Phase II, Drug Therapy
- Medical subject headings
- Carcinoma, Small Cell, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pemetrexed and gemcitabineDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Study Termination
Secondary outcomes (1)
Number of Participants With at Least One Adverse Event
Number of Participants with at least one Adverse Event
Measured: Study Termination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2005 (estimated)
- Study startAug 2005
- Primary completionOct 2006
- Study completionOct 2006
Why it stopped: failure to accrue
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Carcinoma, Small CellStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tufts Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Eli Lilly and Company
- Responsible party
- Sponsor
- Investigators
- John R Goffin, MD FRCPC, Principal investigator, Tufts Medical CenterJohn McCann, MD, Principal investigator, Baystate Medical CenterWalter A Kagan, MD PhD, Principal investigator, Commonwealth Hematology/Oncology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00129974
- Sponsor's protocol ID
- 7338
- Status last verified
- Mar 2017
- First submitted
- 10 Aug 2005
- Last updated
- 16 Jun 2017
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Trial of Pemetrexed in Combination With Gemcitabine as First Line Treatment in Extensive-Stage Small Cell Lung Carcinoma
- ClinicalTrials.gov ID
- NCT00129974
- Acronym / sponsor ID
- 7338
- Conditions
- Carcinoma, Small Cell
- Keywords
- Lung cancer, Phase II, Drug Therapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: failure to accrue
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Tufts Medical CenterUniversity, hospital or other
- Collaborators
- Eli Lilly and Company
- Study start
- Aug 2005
- Primary completion
- Oct 2006 (actual)
- Study completion
- Oct 2006 (actual)
- First posted
- 12 Aug 2005 (estimated)
- Results
- Posted 16 Jun 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| pemetrexed and gemcitabine | Drug | – |
Primary outcome
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
1 secondary outcome
Number of Participants With at Least One Adverse Event
Time frame: Study Termination
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Tufts-New England Medical Center Division of Hematology OncologyLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John R Goffin, MD FRCPC principal investigator
Tufts Medical Center
John McCann, MD principal investigator
Baystate Medical Center
Walter A Kagan, MD PhD principal investigator
Commonwealth Hematology/Oncology
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing pemetrexed and gemcitabine in people with Carcinoma, Small Cell, run by Tufts Medical Center at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 18 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 16 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 Jun 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Response Rate (time frame: Study Termination). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2017.