Lung CancerPhase 1NCT00890955
Amrubicin + Cyclophosphamide in Advanced Solid Organ Malignancies
A Phase 1 study testing Amrubicin and Cyclophosphamide in people with Lung Cancer, run by Lawrence Einhorn at 10 sites in United States.
Trial summary
Amrubicin has shown single-agent activity in lung cancer. The combination of cyclophosphamide and anthracyclines has been studied and concluded that the combination was tolerable, could be given safely, and therapeutically useful. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer
- What is being tested?
- Amrubicin and Cyclophosphamide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 10 sitesUnited States
- Study dates
- Mar 2009to Jul 2010
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 or cytologically confirmed advanced solid organ malignancy that is refractory to currently available therapies or for which no effective therapy exists.
- Must have measurable or evaluable disease per RECIST as evaluated by imaging within 30 days prior to registration for protocol therapy.
- Must have completed chemotherapy at least 28 days prior to registration for protocol therapy and recovered from the acute toxic effects.
- Prior radiation therapy is allowed to < 25% of the bone marrow. Patients must have recovered from the acute toxic effects of radiation prior to registration for protocol therapy.
- Must be willing to consent to the blood sample collection for SNP analysis.
- Females of childbearing potential and males must be willing to use an effective method of contraception (hormonal or barrier method of birth control; abstinence) from the time of consent until at least 30 days following completion of protocol therapy.
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- Females of childbearing potential must have a negative pregnancy test within 7 days prior to registration for protocol therapy. Patients are considered not of child bearing potential if they are surgically sterile (they have undergone a hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or they are postmenopausal.
- Written informed consent and HIPAA authorization for release of personal health information.
- Age > 18 years.
Who cannot join
- No prior therapy with cyclophosphamide or anthracyclines.
- No treatment with any investigational agent within 28 days prior to registration for protocol therapy.
- No suspected, diffuse idiopathic interstitial lung disease or history of pulmonary fibrosis.
- No evidence of severe or uncontrolled other systemic disease or any concurrent condition which in the investigator's opinion makes it undesirable for the patient to participate in the trial or which would jeopardize compliance with the protocol.
- No symptomatic brain metastases. Patients with treated brain metastasis must be off steroids and must have completed radiation at least 21 days prior to registration for protocol therapy.
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
Cancer Care Center of Southern Indiana
Bloomington, Indiana, 47403
Medical & Surgical Specialists, LLC
Galesburg, Illinois, 61401
Indiana University Simon Cancer Center
Indianapolis, Indiana, 46202
Medical Consultants, P.C.
Muncie, Indiana, 47303
Helen F. Graham Cancer Center
Newark, Delaware, 19713
Providence Portland Medical Center
Portland, Oregon, 97213
Fox Chase Cancer Center Extramural Research Program
Rockledge, Pennsylvania, 19046
Northern Indiana Cancer Research Consortium
South Bend, Indiana, 46601
Highlands Oncology Group
Springdale, Arkansas, 72764
Siteman Cancer Center
St Louis, Missouri, 63110
About this study
Official title: A Phase I Study of Amrubicin and Cyclophosphamide in Patients With Advanced Solid Organ Malignancies
Amrubicin has shown single-agent activity in lung cancer. The combination of cyclophosphamide and anthracyclines has been studied and concluded that the combination was tolerable, could be given safely, and therapeutically useful.
This Phase I study will evaluate the combination of cyclophosphamide with amrubicin in relapsed solid tumors and will define the MTD of the combination in a US population.
Read the detailed description
OUTLINE: This is a multi-center study.
This study will follow the 3+3 design with the following dose levels:
- Dose Level -1: Amrubicin 20mg/m2, Cyclophosphamide 500mg/m2
- Dose Level 1: Amrubicin 25mg/m2, Cyclophosphamide 500mg/m2
- Dose Level 2: Amrubicin 30mg/m2, Cyclophosphamide 500mg/m2
- Dose Level 3: Amrubicin 35mg/m2, Cyclophosphamide 500mg/m2
- Dose Level 4: Amrubicin 40mg/m2, Cyclophosphamide 500mg/m2
Dose escalation starts from dose level 1.
Amrubicin will be given as a slow IV push or infusion over approximately 5 minutes once daily for 3 consecutive days starting on day 1 of each 21 day cycle.
Cyclophosphamide will be given at a fixed dose as an IV infusion over 30-60 minutes on day 1 of each 21 day cycle (following amrubicin).
ECOG Performance Status: 0-1
Life expectancy: not specified
Hematopoietic:
- Hemoglobin (Hgb) > 9 g/dL.
- Platelets > 100 K/mm3
- Absolute Neutrophil Count (ANC) > 1.5 K/mm3
Hepatic:
- Aspartate transaminase (AST) ≤ 2.5 x ULN
- Alanine transaminase (ALT) ≤ 2.5 x ULN
- Total bilirubin < 1.5 x ULN
Renal:
- Calculated creatinine clearance ≥ 60cc/min
Cardiovascular:
- Left Ventricular Ejection Fraction (LVEF) ≥ LLN for institution within 60 days prior to registration for protocol therapy.
- No history of cardiomyopathy or uncontrolled heart arrhythmia.
Pulmonary:
- No suspected, diffuse idiopathic interstitial lung disease or history of pulmonary fibrosis.
- Conditions
- Lung Cancer
- Being tested
- Amrubicin, Cyclophosphamide
- Keywords
- Solid tumors
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AmrubicinDrug
- Dose Level -1: 20mg/m2
- Dose Level 1: 25mg/m2
- Dose Level 2: 30mg/m2
- Dose Level 3: 35mg/m2
- Dose Level 4: 40mg/m2
Amrubicin will be given as a slow IV push or infusion over approximately 5 minutes once daily for 3 consecutive days starting on day 1 of each 21 day cycle.
CyclophosphamideDrug
Cyclophosphamide will be given at a fixed dose as 500mg/m2 IV infusion over 30-60 minutes on day 1 of each 21 day cycle (following amrubicin).
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Amrubicin + Cyclophosphamide 3+3 design with the following dose levels:
Dose Level -1: Amrubicin 20mg/m2, Cyclophosphamide 500mg/m2
Dose Level 1: Amrubicin 25mg/m2, Cyclophosphamide 500mg/m2
Dose Level 2: Amrubicin 30mg/m2, Cyclophosphamide 500mg/m2
Dose Level 3: Amrubicin 35mg/m2, Cyclophosphamide 500mg/m2
Dose Level 4: Amrubicin 40mg/m2, Cyclophosphamide 500mg/m2 Receives: Drug: Amrubicin; Drug: Cyclophosphamide |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the maximum tolerated dose (MTD) and dose limiting toxicities (DLTs) of the combination of amrubicin and cyclophosphamide in patients with advanced solid tumors.
Measured: 24 months
Secondary outcomes (2)
To determine the toxicities of the combination of amrubicin and cyclophosphamide in patients with advanced solid tumors.
Measured: 24 months
To assess response to the combination of amrubicin and cyclophosphamide
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2009 (estimated)
- Study startMar 2009
- Primary completionJul 2010
- Study completionJul 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lung 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lawrence Einhorn
- Sponsor type
- University, hospital or other
- Collaborators
- Celgene Corporation, Hoosier Cancer Research Network
- Responsible party
- Sponsor-investigator, Lawrence Einhorn, Hoosier Cancer Research Network
- Investigators
- Lawrence Einhorn, M.D., Principal investigator, Hoosier Cancer Research Network
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00890955
- Sponsor's protocol ID
- HOG LUN07-130
- Status last verified
- Dec 2015
- First submitted
- 29 Apr 2009
- Last updated
- 23 Dec 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Jalal SI, Hanna N, Zon R, Masters GA, Borghaei H, Koneru K, Badve S, Prasad N, Somaiah N, Wu J, Yu Z, Einhorn L. Phase I Study of Amrubicin and Cyclophosphamide in Patients With Advanced Solid Organ Malignancies: HOG LUN 07-130. Am J Clin Oncol. 2017 Aug;40(4):329-335. doi: 10.1097/COC.0000000000000160.
PubMed 25503432
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study of Amrubicin and Cyclophosphamide in Patients With Advanced Solid Organ Malignancies
- ClinicalTrials.gov ID
- NCT00890955
- Acronym / sponsor ID
- HOG LUN07-130
- Conditions
- Lung Cancer
- Keywords
- Solid tumors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Lawrence EinhornUniversity, hospital or other
- Collaborators
- Celgene Corporation, Hoosier Cancer Research Network
- Study start
- Mar 2009
- Primary completion
- Jul 2010 (actual)
- Study completion
- Jul 2010 (actual)
- First posted
- 30 Apr 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Amrubicin has shown single-agent activity in lung cancer. The combination of cyclophosphamide and anthracyclines has been studied and concluded that the combination was tolerable, could be given safely, and therapeutically useful.
This Phase I study will evaluate the combination of cyclophosphamide with amrubicin in relapsed solid tumors and will define the MTD of the combination in a US population.
Detailed description
OUTLINE: This is a multi-center study.
This study will follow the 3+3 design with the following dose levels:
- Dose Level -1: Amrubicin 20mg/m2, Cyclophosphamide 500mg/m2
- Dose Level 1: Amrubicin 25mg/m2, Cyclophosphamide 500mg/m2
- Dose Level 2: Amrubicin 30mg/m2, Cyclophosphamide 500mg/m2
- Dose Level 3: Amrubicin 35mg/m2, Cyclophosphamide 500mg/m2
- Dose Level 4: Amrubicin 40mg/m2, Cyclophosphamide 500mg/m2
Dose escalation starts from dose level 1.
Amrubicin will be given as a slow IV push or infusion over approximately 5 minutes once daily for 3 consecutive days starting on day 1 of each 21 day cycle.
Cyclophosphamide will be given at a fixed dose as an IV infusion over 30-60 minutes on day 1 of each 21 day cycle (following amrubicin).
ECOG Performance Status: 0-1
Life expectancy: not specified
Hematopoietic:
- Hemoglobin (Hgb) > 9 g/dL.
- Platelets > 100 K/mm3
- Absolute Neutrophil Count (ANC) > 1.5 K/mm3
Hepatic:
- Aspartate transaminase (AST) ≤ 2.5 x ULN
- Alanine transaminase (ALT) ≤ 2.5 x ULN
- Total bilirubin < 1.5 x ULN
Renal:
- Calculated creatinine clearance ≥ 60cc/min
Cardiovascular:
- Left Ventricular Ejection Fraction (LVEF) ≥ LLN for institution within 60 days prior to registration for protocol therapy.
- No history of cardiomyopathy or uncontrolled heart arrhythmia.
Pulmonary:
- No suspected, diffuse idiopathic interstitial lung disease or history of pulmonary fibrosis.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Amrubicin, Drug: CyclophosphamideAmrubicin + Cyclophosphamide 3+3 design with the following dose levels: Dose Level -1: Amrubicin 20mg/m2, Cyclophosphamide 500mg/m2 Dose Level 1: Amrubicin 25mg/m2, Cyclophosphamide 500mg/m2 Dose Level 2: Amrubicin 30mg/m2, Cyclophosphamide 500mg/m2 Dose Level 3: Amrubicin 35mg/m2, Cyclophosphamide 500mg/m2 Dose Level 4: Amrubicin 40mg/m2, Cyclophosphamide 500mg/m2 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Histologically or cytologically confirmed advanced solid organ malignancy that is refractory to currently available therapies or for which no effective therapy exists.
- Must have measurable or evaluable disease per RECIST as evaluated by imaging within 30 days prior to registration for protocol therapy.
- Must have completed chemotherapy at least 28 days prior to registration for protocol therapy and recovered from the acute toxic effects.
- Prior radiation therapy is allowed to < 25% of the bone marrow. Patients must have recovered from the acute toxic effects of radiation prior to registration for protocol therapy.
- Must be willing to consent to the blood sample collection for SNP analysis.
Key exclusion criteria (5 listed)
- No prior therapy with cyclophosphamide or anthracyclines.
- No treatment with any investigational agent within 28 days prior to registration for protocol therapy.
- No suspected, diffuse idiopathic interstitial lung disease or history of pulmonary fibrosis.
- No evidence of severe or uncontrolled other systemic disease or any concurrent condition which in the investigator's opinion makes it undesirable for the patient to participate in the trial or which would jeopardize compliance with the protocol.
- No symptomatic brain metastases. Patients with treated brain metastasis must be off steroids and must have completed radiation at least 21 days prior to registration for protocol therapy.
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 |
|---|---|---|
| Amrubicin* Dose Level -1: 20mg/m2 * Dose Level 1: 25mg/m2 * Dose Level 2: 30mg/m2 * Dose Level 3: 35mg/m2 * Dose Level 4: 40mg/m2 Amrubicin will be given as a slow IV push or infusion over approximately 5 minutes once daily for 3 consecutive days starting on day 1 of each 21 day cycle. | Drug | 1 |
| CyclophosphamideCyclophosphamide will be given at a fixed dose as 500mg/m2 IV infusion over 30-60 minutes on day 1 of each 21 day cycle (following amrubicin). | Drug | 1 |
Primary outcome
To determine the maximum tolerated dose (MTD) and dose limiting toxicities (DLTs) of the combination of amrubicin and cyclophosphamide in patients with advanced solid tumors.
Time frame: 24 months
2 secondary outcomes
To determine the toxicities of the combination of amrubicin and cyclophosphamide in patients with advanced solid tumors.
Time frame: 24 months
To assess response to the combination of amrubicin and cyclophosphamide
Time frame: 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2015.
- Results publication: PubMed 25503432Jalal SI, Hanna N, Zon R, Masters GA, Borghaei H, Koneru K, Badve S, Prasad N, Somaiah N, Wu J, Yu Z, Einhorn L. Phase I Study of Amrubicin and Cyclophosphamide in Patients With Advanced Solid Organ Malignancies: HOG LUN 07-130. Am J Clin Oncol. 2017 Aug;40(4):329-335. doi: 10.1097/COC.0000000000000160.
- Hoosier Oncology Group HomepageLink 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.
Lawrence Einhorn, M.D. principal investigator
Hoosier Cancer Research Network
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Amrubicin and Cyclophosphamide in people with Lung Cancer, run by Lawrence Einhorn at 10 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 9 inclusion and 5 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 23 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 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 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.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
To determine the maximum tolerated dose (MTD) and dose limiting toxicities (DLTs) of the combination of amrubicin and cyclophosphamide in patients with advanced solid tumors. (time frame: 24 months). 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 NCT00890955, 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 23 Dec 2015.