Breast CancerPhase 1/2NCT00470548
Abraxane and Alimta in Advanced Solid Tumors
A Phase 1/2 study testing Abraxane and Alimta in people with Breast Cancer and Lung Cancer, run by University of California, Davis at 1 site in United States.
Trial summary
RATIONALE: Drugs used in chemotherapy, such as paclitaxel albumin-stabilized nanoparticle formulation, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer, Lung Cancer, Unspecified Adult Solid Tumor, Protocol Specific
- What is being tested?
- Abraxane and Alimta
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2007to Oct 2014
- Phase
- Phase 1/2
- 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
- For the phase II portion patients must have cytologically or histologically proven selected stage IIIB (pleural effusion) or IV NSCLC.
- For the phase II portion patients must have NSCLC that has progressed or recurred after treatment with platinum-based therapy.
- No prior pemetrexed. Prior Taxol is allowed. Prior ABI 007 is not allowed.
- Patients must have measurable disease by RECIST criteria for the phase II portion.
- Patients must be 18 years of age or older.
- Patients must have a performance status of 0 -2
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- Patients must have an estimated survival of at least 3 months.
- Any prior chemotherapy must have been completed at least 4 weeks prior to start of treatment.
- Patients must have adequate renal function as documented by a calculated creatinine clearance of > 45 ml/min
- Patients must have adequate liver functions: AST and ALT < 2.5 X upper limit of normal, and bilirubin < upper limit of normal.
- Patients must have adequate bone marrow function: Platelets >100,000 cells/mm3 and ANC > 1,500 cells/mm3.
- For patients who have baseline clinically significant pleural or peritoneal effusions (on the basis of symptoms or clinical examination) before initiation of pemetrexed therapy, consideration should be given to draining the effusion prior to dosing.
- Patients with asymptomatic treated brain metastasis (surgical resection or radiotherapy) may be included if they are neurologically stable and have been off steroids and anticonvulsants for at least 4 weeks.
- Patients must be able to take and retain oral medication.
- Ability to take folic acid, vitamin B12 and dexamethasone according to protocol.
- Ability to interrupt NSAIDS 2 days before, the day of, and 2 days following administration of pemetrexed.
- Patients of reproductive potential must agree to use effective contraceptive method while on treatment and for 3 months afterwards as the effects of these drugs on the unborn fetus are unknown.
- No other current active malignancy.
- Patient or his/her legally authorized representative or guardian signed the Informed Consent form prior to participation in any study-related activities.
Who cannot join
- Pregnant or breastfeeding women.
- Patient with pre-existing peripheral neuropathy of NCI CTCAE Version 3.0 of grade 2.
- Patient has a clinically significant concurrent illness.
- Patient is currently enrolled in a different clinical study in which investigational procedures are performed or investigational therapies are administered.
- Patient has a history of allergy or hypersensitivity to the study drugs or a taxane.
- Patient has serious medical risk factors involving any of the major organ systems such that the investigator considers it unsafe for the patient to receive an experimental research drug.
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- Prior therapy with pemetrexed, or ABI-007.
- Patient is receiving treatment with any excluded concomitant medication.
- Presence of third space fluid which cannot be controlled by drainage.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California Davis Cancer Center
Sacramento, California, 95817
About this study
Official title: Phase I/II Trial of Abraxane® (ABI-007) and Alimta® (Pemetrexed) in Advanced Solid Tumors With Emphasis on Non-Small Cell Lung Cancer (NSCLC) and Breast Cancer
RATIONALE: Drugs used in chemotherapy, such as paclitaxel albumin-stabilized nanoparticle formulation, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Pemetrexed may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving paclitaxel albumin-stabilized nanoparticle formulation together with pemetrexed may kill more tumor cells.
PURPOSE: This phase I/II trial is studying the side effects and best dose of paclitaxel albumin-stabilized nanoparticle formulation when given together with pemetrexed and to see how well they work in treating patients with advanced non-small cell lung cancer, breast cancer, or other solid tumors.
Read the detailed description
OBJECTIVES:
Primary
- Determine the safety of paclitaxel albumin-stabilized nanoparticle formulation when administered with pemetrexed disodium in patients with advanced non-small cell lung cancer, breast cancer, or other solid tumors. (Phase I)
- Determine the efficacy of this regimen, as measured by objective tumor response rate (RECIST criteria), in these patients. (Phase II)
Secondary
- Determine the preliminary efficacy of paclitaxel albumin-stabilized nanoparticle formulation and pemetrexed disodium in these patients. (Phase I)
- Determine the overall survival of patients treated with this regimen. (Phase II)
- Evaluate the frequency and severity of toxicities associated with this regimen. (Phase II)
OUTLINE: This is a phase I, dose-escalation study of paclitaxel albumin-stabilized nanoparticle formulation followed by an open-label, phase II study.
- Phase I: Patients receive pemetrexed disodium IV over 10 minutes and paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of paclitaxel albumin-stabilized nanoparticle formulation until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.
- Phase II: Patients receive pemetrexed disodium and paclitaxel albumin-stabilized nanoparticle formulation at the MTD as in phase I.
After completion of study treatment, patients are followed periodically.
- Being tested
- Abraxane, Alimta
- Keywords
- male breast cancer, recurrent breast cancer, stage IIIA breast cancer, stage IIIB breast cancer, stage IIIC breast cancer, stage IV breast cancer, stage IIIA non-small cell lung cancer, stage IIIB non-small cell lung cancer, stage IV non-small cell lung cancer, recurrent non-small cell lung cancer, unspecified adult solid tumor, protocol specific
- Medical subject headings
- Breast Neoplasms, Lung Neoplasms, Breast Neoplasms, Male, Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AbraxaneDrug
Also called paclitaxel albumin-stabilized nanoparticle formulation, ABI-007
ABI-007 IV administration following pemetrexed on Day 1 of each cycle (infused over 30 minutes)
AlimtaDrug
Also called pemetrexed disodium
Pemetrexed IV administration on Day 1 of each cycle (infused over 10 minutes)
| Study group | Role | What they receive |
|---|---|---|
| Phase I: Abraxane and Alimta | Experimental | Three dose levels were tested. Pemetrexed 500mg/m2 day 1 and nab-paclitaxel day 1 at 180, 220, and 260 mg/m2 every 21 days. Receives: Drug: Abraxane; Drug: Alimta |
| Phase II: Abraxane and Alimta | Experimental | Pemetrexed 500mg/m2 day 1 and nab-paclitaxel day 1 at 260 mg/m2 every 21 days. Receives: Drug: Abraxane; Drug: Alimta |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Dose Limiting Toxicities
Dose limiting toxicity (DLT) was defined as any of the following occurring during the first cycle: Grade 4 thrombocytopenia, or grade 3 thrombocytopenia associated with bleeding, requirement for transfusion, febrile neutropenia, neutropenia with documented infection. Non-hematologic DLT included any other ≥ grade 3 non-hematologic toxicity that was clinically significant and considered by the investigator to be related to study drug. Alopecia and grade 3 allergic reaction/hypersensitivity with infusion were not considered DLTs.
Measured: Up to21 days
Number of Patients With Toxicities
Toxicities was evaluated based on the standard NCI CTCAE Version 3.0 grading criteria. Attributable grade ≥ 3 hematologic and non-hematologic toxicities are presented here.
Measured: Up to 1 year
Secondary outcomes (5)
Duration of Overall Survival
From time of enrollment to the first observation of disease progression or death.
Measured: Up to 2 years
Number of Participants With Complete Response
Per RECIST criteria, complete response (CR) is defined as the disappearance of all target lesions.
Measured: Up to 2 years
Number of Participants With Stable Disease
Stable Disease is measured from the start of the treatment until the criteria for disease progression are met. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions
Measured: Up to 2 years
Number of Participants With Partial Response
At least a 30% decrease in the sum of the longest diameter of target lesions
Measured: Up to 2 years
Number of Participants With Disease Control
Disease control is complete response plus partial response plus stable disease from the start of treatment to death or disease progression.
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2007 (estimated)
- Study startApr 2007
- Primary completionOct 2014
- Study completionOct 2014
Why it stopped: Practice patterns with pemetrexed have evolved.
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Davis
- Sponsor type
- University, hospital or other
- Collaborators
- Celgene, Eli Lilly and Company
- Responsible party
- Sponsor
- Investigators
- David R. Gandara, MD, Study chair, University of California, Davis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00470548
- Sponsor's protocol ID
- UCDCC#185
- Other IDs
- 224355, ABX027, H3E-US-I017
- Status last verified
- Jan 2018
- First submitted
- 3 May 2007
- Last updated
- 10 Jan 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Ho C, Davies AM, Sangha RS, Lau D, Lara P Jr, Chew HK, Beckett L, Mack PC, Riess JW, Gandara DR. Phase I/II trial of pemetrexed plus nab-paclitaxel in advanced solid tumor patients with emphasis on non-small cell lung cancer. Invest New Drugs. 2013 Dec;31(6):1587-91. doi: 10.1007/s10637-013-0024-y. Epub 2013 Sep 8.
PubMed 24013936
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I/II Trial of Abraxane® (ABI-007) and Alimta® (Pemetrexed) in Advanced Solid Tumors With Emphasis on Non-Small Cell Lung Cancer (NSCLC) and Breast Cancer
- ClinicalTrials.gov ID
- NCT00470548
- Acronym / sponsor ID
- UCDCC#185
- Keywords
- male breast cancer, recurrent breast cancer, stage IIIA breast cancer, stage IIIB breast cancer, stage IIIC breast cancer, stage IV breast cancer, stage IIIA non-small cell lung cancer, stage IIIB non-small cell lung cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Practice patterns with pemetrexed have evolved.
- Enrolment
- 49 participants (actual)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Collaborators
- Celgene, Eli Lilly and Company
- Study start
- Apr 2007
- Primary completion
- Oct 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 7 May 2007 (estimated)
- Results
- Posted 8 Mar 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
RATIONALE: Drugs used in chemotherapy, such as paclitaxel albumin-stabilized nanoparticle formulation, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Pemetrexed may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving paclitaxel albumin-stabilized nanoparticle formulation together with pemetrexed may kill more tumor cells.
PURPOSE: This phase I/II trial is studying the side effects and best dose of paclitaxel albumin-stabilized nanoparticle formulation when given together with pemetrexed and to see how well they work in treating patients with advanced non-small cell lung cancer, breast cancer, or other solid tumors.
Detailed description
OBJECTIVES:
Primary
- Determine the safety of paclitaxel albumin-stabilized nanoparticle formulation when administered with pemetrexed disodium in patients with advanced non-small cell lung cancer, breast cancer, or other solid tumors. (Phase I)
- Determine the efficacy of this regimen, as measured by objective tumor response rate (RECIST criteria), in these patients. (Phase II)
Secondary
- Determine the preliminary efficacy of paclitaxel albumin-stabilized nanoparticle formulation and pemetrexed disodium in these patients. (Phase I)
- Determine the overall survival of patients treated with this regimen. (Phase II)
- Evaluate the frequency and severity of toxicities associated with this regimen. (Phase II)
OUTLINE: This is a phase I, dose-escalation study of paclitaxel albumin-stabilized nanoparticle formulation followed by an open-label, phase II study.
- Phase I: Patients receive pemetrexed disodium IV over 10 minutes and paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of paclitaxel albumin-stabilized nanoparticle formulation until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.
- Phase II: Patients receive pemetrexed disodium and paclitaxel albumin-stabilized nanoparticle formulation at the MTD as in phase I.
After completion of study treatment, patients are followed periodically.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Phase I: Abraxane and Alimta | Experimental | Drug: Abraxane, Drug: AlimtaThree dose levels were tested. Pemetrexed 500mg/m2 day 1 and nab-paclitaxel day 1 at 180, 220, and 260 mg/m2 every 21 days. |
| Phase II: Abraxane and Alimta | Experimental | Drug: Abraxane, Drug: AlimtaPemetrexed 500mg/m2 day 1 and nab-paclitaxel day 1 at 260 mg/m2 every 21 days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- For the phase II portion patients must have cytologically or histologically proven selected stage IIIB (pleural effusion) or IV NSCLC.
- For the phase II portion patients must have NSCLC that has progressed or recurred after treatment with platinum-based therapy.
- No prior pemetrexed. Prior Taxol is allowed. Prior ABI 007 is not allowed.
- Patients must have measurable disease by RECIST criteria for the phase II portion.
- Patients must be 18 years of age or older.
Key exclusion criteria (9 listed)
- Pregnant or breastfeeding women.
- Patient with pre-existing peripheral neuropathy of NCI CTCAE Version 3.0 of grade 2.
- Patient has a clinically significant concurrent illness.
- Patient is currently enrolled in a different clinical study in which investigational procedures are performed or investigational therapies are administered.
- Patient has a history of allergy or hypersensitivity to the study drugs or a taxane.
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 |
|---|---|---|
| AbraxaneAlso: paclitaxel albumin-stabilized nanoparticle formulation, ABI-007ABI-007 IV administration following pemetrexed on Day 1 of each cycle (infused over 30 minutes) | Drug | Phase I: Abraxane and Alimta, Phase II: Abraxane and Alimta |
| AlimtaAlso: pemetrexed disodiumPemetrexed IV administration on Day 1 of each cycle (infused over 10 minutes) | Drug | Phase I: Abraxane and Alimta, Phase II: Abraxane and Alimta |
Primary outcome
Number of Participants With Dose Limiting Toxicities
Time frame: Up to21 days
Dose limiting toxicity (DLT) was defined as any of the following occurring during the first cycle: Grade 4 thrombocytopenia, or grade 3 thrombocytopenia associated with bleeding, requirement for transfusion, febrile neutropenia, neutropenia with documented infection. Non-hematologic DLT included any other ≥ grade 3 non-hematologic toxicity that was clinically significant and considered by the investigator to be related to study drug. Alopecia and grade 3 allergic reaction/hypersensitivity with infusion were not considered DLTs.
Number of Patients With Toxicities
Time frame: Up to 1 year
Toxicities was evaluated based on the standard NCI CTCAE Version 3.0 grading criteria. Attributable grade ≥ 3 hematologic and non-hematologic toxicities are presented here.
5 secondary outcomes
Duration of Overall Survival
Time frame: Up to 2 years
Number of Participants With Complete Response
Time frame: Up to 2 years
Number of Participants With Stable Disease
Time frame: Up to 2 years
Number of Participants With Partial Response
Time frame: Up to 2 years
Number of Participants With Disease Control
Time frame: Up to 2 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 24013936Ho C, Davies AM, Sangha RS, Lau D, Lara P Jr, Chew HK, Beckett L, Mack PC, Riess JW, Gandara DR. Phase I/II trial of pemetrexed plus nab-paclitaxel in advanced solid tumor patients with emphasis on non-small cell lung cancer. Invest New Drugs. 2013 Dec;31(6):1587-91. doi: 10.1007/s10637-013-0024-y. Epub 2013 Sep 8.
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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.
David R. Gandara, MD study chair
University of California, Davis
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Abraxane and Alimta in people with Breast Cancer and Lung Cancer, run by University of California, Davis 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 19 inclusion and 9 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 10 Jan 2018. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 8 Mar 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?
Number of Participants With Dose Limiting Toxicities (time frame: Up to21 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00470548, which also lists 1 linked publication.
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 10 Jan 2018.