Sarcoma, Soft TissuePhase 2NCT00860015
Alimta Plus Gemcitabine for Advanced Sarcoma
A Phase 2 study testing Alimta and Gemcitabine in people with Sarcoma, Soft Tissue, run by Columbia University at 1 site in United States.
Trial summary
In patients with unresectable soft tissue sarcoma, what is the response rate if treated with Alimta and gemcitabine? Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sarcoma, Soft Tissue
- What is being tested?
- Alimta and Gemcitabine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2005to Apr 2012
- 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
- Histologically proven soft tissue sarcoma (except the following histologies: gastrointestinal stromal tumors (GIST), Kaposi's Sarcoma, mesotheliomas).
- Age ≥ 18 years
- Recurrent or progressive disease defined as an increase in size of any existing tumor mass, or the development of new tumor mass or masses, which is not amenable to definitive surgical therapy.
- Patients may have had another cancer but there must be convincing clinical evidence that the sarcoma is the disease requiring therapeutic intervention. (i.e. Several sarcoma patients have had had a prior cancer [Hodgkin's disease or breast cancer] treated years previously and then developed a clinically active sarcoma.)
- Patients may have received no prior chemotherapy, or may have failed 0-2 prior cytotoxic regimens.
- Measurable disease defined as lesions that can be measured in at least one dimension by physical examination or by means of medical imaging techniques. Ascites and pleural effusions will not be considered measurable disease.
- Karnofsky performance status of greater than or equal to 60%.
- At least 3 weeks since prior chemotherapy or at least 6 weeks since prior radiation therapy.
Who cannot join
- Soft tissue sarcomas with the following histologies: gastrointestinal stromal tumors (GIST), Kaposi's sarcoma, mesotheliomas.
- Active or uncontrolled infection
- Prior treatment with gemcitabine or Alimta
- Pregnant or lactating women
- Uncontrolled central nervous system metastases
- Inability to stop treatment with NSAIDs
Trial locations and contacts
1 site in 1 country.
United States1 site
Columbia University Medical Center
New York, New York, 10032
About this study
Official title: Alimta Plus Gemcitabine as Chemotherapy for Patients With Advanced Sarcoma: A Phase II Clinical
In patients with unresectable soft tissue sarcoma, what is the response rate if treated with Alimta and gemcitabine?
Read the detailed description
Soft tissue sarcomas represent 0.7% of all malignancies diagnosed in the United States. The peak incidence occurs in children and young adults with a second peak occurring in middle age, resulting in significant morbidity and mortality in young, productive individuals. Although limb preserving surgery and radiation therapy have improved the primary treatment of these tumors, the therapy of advanced, metastatic tumors is unsatisfactory. The purpose of this phase II study is to evaluate the efficacy of treatment with Alimta and gemcitabine given on day 1 of a 14 day cycle to patients with unresectable or metastatic soft tissue sarcomas. Gemcitabine is an established salvage therapy for soft tissue sarcomas in combination with docetaxel. Alimta is a multitargeted antifolate drug which inhibits several folate dependent enzymes required for cell proliferation. Alimta has shown efficacy in several solid tumor types both as a single agent and in combination with other agents. The combination of Alimta and gemcitabine is synergistic and is likely to have efficacy against soft tissue sarcomas. The primary objective of this study is to determine the response rate among patients with unresectable soft tissue sarcoma treated with this combination. Secondary endpoints will evaluate the median survival of this patient population, as well as time to objective tumor response, time to treatment failure and overall survival. The toxicities of this regimen in this population will also be analyzed. Given the desperate need for new agents to treat these patients, a phase II trial of this combination therapy should be pursued.
- Conditions
- Sarcoma, Soft Tissue
- Being tested
- Alimta, Gemcitabine
- Medical subject headings
- Sarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AlimtaDrug
Also called Pemetrexed
500 mg/m2 via IV over 10 minutes
A chemotherapy drug with indications to treat pleural mesothelioma and non-small cell lung cancer.
GemcitabineDrug
Also called Gemzar
1000 mg/m2 via IV over 90 minutes
A nucleoside analog used as chemotherapy.
| Study group | Role | What they receive |
|---|---|---|
| Alimta/Gemcitabine | Experimental | IV administration of drugs for 14 days for up to 4 cycles Receives: Drug: Alimta; Drug: Gemcitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tumor Best Response Rate
The best response rate will include patients with both Complete Response and Partial Response after 2 months of treatment. 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: Two months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2009 (estimated)
- Study startAug 2005
- Primary completionAug 2009
- Study completionApr 2012
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 Sarcoma, Soft TissueStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Robert N Taub, MD, PhD, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00860015
- Sponsor's protocol ID
- AAAB4160
- Status last verified
- Aug 2020
- First submitted
- 9 Mar 2009
- Last updated
- 25 Aug 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Alimta Plus Gemcitabine as Chemotherapy for Patients With Advanced Sarcoma: A Phase II Clinical
- ClinicalTrials.gov ID
- NCT00860015
- Acronym / sponsor ID
- AAAB4160
- Conditions
- Sarcoma, Soft Tissue
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Study start
- Aug 2005
- Primary completion
- Aug 2009 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 11 Mar 2009 (estimated)
- Results
- Posted 25 Aug 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In patients with unresectable soft tissue sarcoma, what is the response rate if treated with Alimta and gemcitabine?
Detailed description
Soft tissue sarcomas represent 0.7% of all malignancies diagnosed in the United States. The peak incidence occurs in children and young adults with a second peak occurring in middle age, resulting in significant morbidity and mortality in young, productive individuals. Although limb preserving surgery and radiation therapy have improved the primary treatment of these tumors, the therapy of advanced, metastatic tumors is unsatisfactory. The purpose of this phase II study is to evaluate the efficacy of treatment with Alimta and gemcitabine given on day 1 of a 14 day cycle to patients with unresectable or metastatic soft tissue sarcomas. Gemcitabine is an established salvage therapy for soft tissue sarcomas in combination with docetaxel. Alimta is a multitargeted antifolate drug which inhibits several folate dependent enzymes required for cell proliferation. Alimta has shown efficacy in several solid tumor types both as a single agent and in combination with other agents. The combination of Alimta and gemcitabine is synergistic and is likely to have efficacy against soft tissue sarcomas. The primary objective of this study is to determine the response rate among patients with unresectable soft tissue sarcoma treated with this combination. Secondary endpoints will evaluate the median survival of this patient population, as well as time to objective tumor response, time to treatment failure and overall survival. The toxicities of this regimen in this population will also be analyzed. Given the desperate need for new agents to treat these patients, a phase II trial of this combination therapy should be pursued.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Alimta/Gemcitabine | Experimental | Drug: Alimta, Drug: GemcitabineIV administration of drugs for 14 days for up to 4 cycles |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Histologically proven soft tissue sarcoma (except the following histologies: gastrointestinal stromal tumors (GIST), Kaposi's Sarcoma, mesotheliomas).
- Age ≥ 18 years
- Recurrent or progressive disease defined as an increase in size of any existing tumor mass, or the development of new tumor mass or masses, which is not amenable to definitive surgical therapy.
- Patients may have had another cancer but there must be convincing clinical evidence that the sarcoma is the disease requiring therapeutic intervention. (i.e. Several sarcoma patients have had had a prior cancer [Hodgkin's disease or breast cancer] treated years previously and then developed a clinically active sarcoma.)
- Patients may have received no prior chemotherapy, or may have failed 0-2 prior cytotoxic regimens.
Key exclusion criteria (6 listed)
- Soft tissue sarcomas with the following histologies: gastrointestinal stromal tumors (GIST), Kaposi's sarcoma, mesotheliomas.
- Active or uncontrolled infection
- Prior treatment with gemcitabine or Alimta
- Pregnant or lactating women
- Uncontrolled central nervous system metastases
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 |
|---|---|---|
| AlimtaAlso: Pemetrexed500 mg/m2 via IV over 10 minutes A chemotherapy drug with indications to treat pleural mesothelioma and non-small cell lung cancer. | Drug | Alimta/Gemcitabine |
| GemcitabineAlso: Gemzar1000 mg/m2 via IV over 90 minutes A nucleoside analog used as chemotherapy. | Drug | Alimta/Gemcitabine |
Primary outcome
Tumor Best Response Rate
Time frame: Two months
The best response rate will include patients with both Complete Response and Partial Response after 2 months of treatment. 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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
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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.
Robert N Taub, MD, PhD principal investigator
Columbia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Alimta and Gemcitabine in people with Sarcoma, Soft Tissue, run by Columbia University at 1 site 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 8 inclusion and 6 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: finished, as of the sponsor's last update on 25 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 25 Aug 2020). 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?
Tumor Best Response Rate (time frame: Two months). 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 25 Aug 2020.