Breast CancerPhase 1NCT00703638
Sorafenib, Pemetrexed, and Cisplatin in Treating Patients With Advanced Solid Tumors
A Phase 1 study testing cisplatin, pemetrexed disodium and sorafenib in people with Breast Cancer and Colorectal Cancer, run by Masonic Cancer Center, University of Minnesota at 1 site in United States.
Trial summary
RATIONALE: Sorafenib and pemetrexed may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Sorafenib may also stop the growth of tumor cells by blocking blood flow to the tumor. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer, Colorectal Cancer, Head and Neck Cancer
- What is being tested?
- cisplatin, pemetrexed disodium and sorafenib
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- May 2008to Nov 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
- Histologic or cytologic diagnosis of advanced non-hematologic malignancy (except squamous cell of the lung) including, but not limited to breast, lung, colon, pancreatic, prostate, head and neck, or sarcoma
- Must have failed or become intolerant to prior standard therapy and is no longer likely to respond to such therapy except for patients diagnosed with mesothelioma. Mesothelioma patients may be enrolled with no prior therapy requirements since cisplatin and pemetrexed in combination is the current standard of care 1st line therapy.
- At least 21 days must have passed from previous systemic therapy (at least 6 weeks for prior bevacizumab) and the patient must have recovered from the all toxic effects of previous treatment prior to study enrollment. Prior treatment with cisplatin and/or pemetrexed is allowed, but at least 3 months must have passed since the last dose. Prior treatment with sorafenib is not allowed.
- Prior radiation therapy is allowed except to the whole pelvis. At least 14 days from last radiation therapy treatment and must have recovered from the acute toxic effects prior to study enrollment.
- Measurable or non-measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) criteria
- Eastern Cooperative Oncology Group (ECOG) Performance status of 0 to 2
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- 18 years of age and older
- Adequate organ function within 7 days of study enrollment including the following:
- Adequate bone marrow reserve: absolute neutrophil count (ANC) ≥ 1.5 x 10^9/L; platelets ≥100 x 10^9/L; hemoglobin ≥ 9 g/dL
- Hepatic: bilirubin ≤1.5 times the upper limit of normal (× ULN); alkaline phosphatase (ALP), aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 3.0 × ULN (ALP, AST, and ALT ≤ 5× ULN is acceptable if liver has tumor involvement)
- Renal: serum creatinine ≤ 1.5 and calculated creatinine clearance > 45.
- The creatinine clearance is determined by the Cockcroft-Gault formula:
- Males: cr cl (mL)/min) = weight (kg) x (140-age)divided by 72 x serum creatinine (mg/dL)
- Females: cr cl (mL)/min) = weight (kg) x (140-age) x 0.85 divided by 72 x serum creatinine (mg/dL)
- Coagulation: INR < 1.5 or a PT/PTT within normal limits
- Patients receiving anti-coagulation treatment with an agent such as warfarin or heparin may be allowed to participate. For patients on warfarin, the INR should be measured prior to initiation of sorafenib and monitored at least weekly, or as defined by the local standard of care, until INR is stable.
- Women of childbearing potential and sexually active males are required to use an effective method of contraception (barrier method of birth control) during the study and for 2 weeks after the last dose of sorafenib.
- Must be able to take folic acid and vitamin B12.
- Must be able and willing to interrupt aspirin or other nonsteroidal antiinflammatory agents for a 5 day period (8 day period for long acting agents such as piroxicam) prior at the time of each pemetrexed administration.
- Must be able to take oral medications without crushing, dissolving, or chewing tablets.
- Voluntary written informed consent before performance of any study related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care.
Who cannot join
- Squamous cell of the lung
- Pregnant (positive pregnancy test) or breast-feeding. Pemetrexed, cisplatin and sorafenib are pregnancy category D - clear evidence of risk in pregnancy. Women of child bearing potential must have a negative serum or urine pregnancy test within 7 days of prior to the start of treatment. Pregnancy testing is not required for postmenopausal or surgically sterilized women.
- Cardiac disease: Congestive heart failure > class II New York Heart Association Classification (NYHA). Patients must not have unstable angina (anginal symptoms at rest) or new onset angina (began within the last 3 months) or myocardial infarction within the past 6 months.
- Symptomatic or active brain metastases. Patients with neurological symptoms or previously treated CNS metastases must undergo a CT scan/MRI of the brain within 14 days of study enrollment to rule-out brain metastasis.
- The presence of clinically significant third space fluid such as pleural effusion or ascites. Patients in whom the third space fluid can be completely drained may be enrolled.
- Cardiac ventricular arrhythmias requiring anti-arrhythmic therapy
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- Uncontrolled hypertension defined as systolic blood pressure > 150 mmHg or diastolic pressure > 90 mmHg, despite optimal medical management
- Known or suspected allergy to sorafenib, pemetrexed, cisplatin or any agent given in the course of this trial
- Known human immunodeficiency virus (HIV) infection or chronic Hepatitis B or C
- Patients must not have a second primary malignancy except in situ carcinoma of the cervix or breast or other in situ malignancies or adequately treated basal cell carcinoma of the skin or other malignancy treated at least 3 years previously with no evidence of recurrence
- Active clinically serious infection > Common Toxicity Criteria for Adverse Events (CTCAE) Grade 2
- Thrombolic or embolic events such as a cerebrovascular accident including transient ischemic attacks within the past 6 months
- Pulmonary hemorrhage/bleeding event ≥ CTCAE Grade 2 within 4 weeks of first dose of study drug
- Any other hemorrhage/bleeding event ≥ CTCAE Grade 3 within 4 weeks of first dose of study drug
- Serious non-healing wound, ulcer, or bone fracture
- Evidence or history of bleeding diathesis or coagulopathy
- Peripheral neuropathy ≥ CTCAE Grade 2
- Major surgery, open biopsy or significant traumatic injury within 4 weeks of first study drug
- Use of St. John's Wort or rifampin (rifampicin)
- Any condition that impairs patient's ability to swallow whole pills
- Any malabsorption problem
Trial locations and contacts
1 site in 1 country.
United States1 site
Masonic Cancer Center, University of Minnesota
Minneapolis, Minnesota, 55455
About this study
Official title: Phase I Study of Sorafenib, Pemetrexed, and Cisplatin for the Treatment of Advanced Solid Tumors.
RATIONALE: Sorafenib and pemetrexed may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Sorafenib may also stop the growth of tumor cells by blocking blood flow to the tumor. Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving sorafenib together with pemetrexed and cisplatin may kill more tumor cells.
PURPOSE: This phase I trial is studying the side effects and best dose of sorafenib when given together with pemetrexed and cisplatin in treating patients with advanced solid tumors.
Read the detailed description
OBJECTIVES:
Primary
- To determine the maximum tolerated dose of sorafenib tosylate when given in combination with pemetrexed disodium and cisplatin in patients with advanced non-squamous cell solid tumor malignancy including, but not limited to, breast, lung, colon, pancreatic, prostate, or head and neck cancer or sarcoma.
Secondary
- To characterize the quantitative and qualitative toxicities of this regimen in these patients.
- To obtain preliminary information about the antitumor activity of this regimen in these patients.
OUTLINE: This is a dose-escalation study of sorafenib tosylate.
Patients receive oral sorafenib tosylate once daily on days 1-21 and cisplatin IV over 1-2 hours and pemetrexed disodium IV over 10 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed at 30 days, every 8 weeks until disease progression, and then every 3 months for up to 6 months.
- Conditions
- Breast Cancer, Colorectal Cancer, Head and Neck Cancer, Lung Cancer, Mesothelioma, Pancreatic Cancer
- Medical subject headings
- Breast Neoplasms, Colorectal Neoplasms, Head and Neck Neoplasms, Lung Neoplasms, Mesothelioma, Pancreatic Neoplasms, Prostatic Neoplasms, Sarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cisplatinDrug
Also called CDDP, Platinol
Cisplatin administered intravenously, 75 mg/m^2 over 1-2 hours on day 1 of a 21 day cycle
pemetrexed disodiumDrug
Also called Alimta, MTA, LY231514
Pemetrexed 500 mg/m^2 intravenously (IV) will be given as a 10-minute intravenous infusion (after cisplatin) on day 1 of a 21 day cycle
sorafenibDrug
Also called BAY 43-9006 tosylate, NSC 724772
daily oral sorafenib (200 mg or 400 mg bid)
| Study group | Role | What they receive |
|---|---|---|
| Sorafenib/Pemetrexed/Cisplatin | Experimental | Patients receiving a dose escalation scheme of daily oral sorafenib (200 mg or 400 mg bid) when given in combination with fixed dose intravenous pemetrexed and cisplatin for the treatment of solid tumors. Receives: Drug: cisplatin; Drug: pemetrexed disodium; Drug: sorafenib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum tolerated dose of sorafenib tosylate
This dose level is declared to be above the maximum tolerated dose (MTD) and dose escalation is stopped. Declare the next lower dose the MTD if 6 patients have already been treated at that dose.
Measured: From first dose to toxicity event
Secondary outcomes (2)
Disease Response
Each patient will be assigned one of the following Response Evaluation Criteria in Solid Tumors (RECIST) categories:
- complete response;
- partial response;
- stable disease;
- progressive disease;
- early death from malignant disease;
- unknown (insufficient evaluation to determine response status).
Measured: At 6- 8 weeks
Maximum, Minimum and AUC Concentrations of Sorafenib
Maximum and minimum serum concentrations and area under the concentration time curve (AUC) for sorafenib will be predicted using standard pharmacokinetic software
Measured: Day 1 to Day 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2008 (estimated)
- Study startMay 2008
- Primary completionSep 2010
- Study completionNov 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Masonic Cancer Center, University of MinnesotaThe 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Masonic Cancer Center, University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Priya Kumar, MD, Principal investigator, Masonic Cancer Center, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00703638
- Sponsor's protocol ID
- 2007LS086
- Other IDs
- 0712M22703
- Status last verified
- Nov 2017
- First submitted
- 20 Jun 2008
- Last updated
- 29 Nov 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Study of Sorafenib, Pemetrexed, and Cisplatin for the Treatment of Advanced Solid Tumors.
- ClinicalTrials.gov ID
- NCT00703638
- Acronym / sponsor ID
- 2007LS086
- Conditions
- Breast Cancer, Colorectal Cancer, Head and Neck Cancer, Lung Cancer, Mesothelioma, Pancreatic Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Masonic Cancer Center, University of MinnesotaUniversity, hospital or other
- Study start
- May 2008
- Primary completion
- Sep 2010 (actual)
- Study completion
- Nov 2010 (actual)
- First posted
- 23 Jun 2008 (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.
RATIONALE: Sorafenib and pemetrexed may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Sorafenib may also stop the growth of tumor cells by blocking blood flow to the tumor. Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving sorafenib together with pemetrexed and cisplatin may kill more tumor cells.
PURPOSE: This phase I trial is studying the side effects and best dose of sorafenib when given together with pemetrexed and cisplatin in treating patients with advanced solid tumors.
Detailed description
OBJECTIVES:
Primary
- To determine the maximum tolerated dose of sorafenib tosylate when given in combination with pemetrexed disodium and cisplatin in patients with advanced non-squamous cell solid tumor malignancy including, but not limited to, breast, lung, colon, pancreatic, prostate, or head and neck cancer or sarcoma.
Secondary
- To characterize the quantitative and qualitative toxicities of this regimen in these patients.
- To obtain preliminary information about the antitumor activity of this regimen in these patients.
OUTLINE: This is a dose-escalation study of sorafenib tosylate.
Patients receive oral sorafenib tosylate once daily on days 1-21 and cisplatin IV over 1-2 hours and pemetrexed disodium IV over 10 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed at 30 days, every 8 weeks until disease progression, and then every 3 months for up to 6 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sorafenib/Pemetrexed/Cisplatin | Experimental | Drug: cisplatin, Drug: pemetrexed disodium, Drug: sorafenibPatients receiving a dose escalation scheme of daily oral sorafenib (200 mg or 400 mg bid) when given in combination with fixed dose intravenous pemetrexed and cisplatin for the treatment of solid tumors. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- Histologic or cytologic diagnosis of advanced non-hematologic malignancy (except squamous cell of the lung) including, but not limited to breast, lung, colon, pancreatic, prostate, head and neck, or sarcoma
- Must have failed or become intolerant to prior standard therapy and is no longer likely to respond to such therapy except for patients diagnosed with mesothelioma. Mesothelioma patients may be enrolled with no prior therapy requirements since cisplatin and pemetrexed in combination is the current standard of care 1st line therapy.
- At least 21 days must have passed from previous systemic therapy (at least 6 weeks for prior bevacizumab) and the patient must have recovered from the all toxic effects of previous treatment prior to study enrollment. Prior treatment with cisplatin and/or pemetrexed is allowed, but at least 3 months must have passed since the last dose. Prior treatment with sorafenib is not allowed.
- Prior radiation therapy is allowed except to the whole pelvis. At least 14 days from last radiation therapy treatment and must have recovered from the acute toxic effects prior to study enrollment.
- Measurable or non-measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) criteria
Key exclusion criteria (21 listed)
- Squamous cell of the lung
- Pregnant (positive pregnancy test) or breast-feeding. Pemetrexed, cisplatin and sorafenib are pregnancy category D - clear evidence of risk in pregnancy. Women of child bearing potential must have a negative serum or urine pregnancy test within 7 days of prior to the start of treatment. Pregnancy testing is not required for postmenopausal or surgically sterilized women.
- Cardiac disease: Congestive heart failure > class II New York Heart Association Classification (NYHA). Patients must not have unstable angina (anginal symptoms at rest) or new onset angina (began within the last 3 months) or myocardial infarction within the past 6 months.
- Symptomatic or active brain metastases. Patients with neurological symptoms or previously treated CNS metastases must undergo a CT scan/MRI of the brain within 14 days of study enrollment to rule-out brain metastasis.
- The presence of clinically significant third space fluid such as pleural effusion or ascites. Patients in whom the third space fluid can be completely drained may be enrolled.
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 |
|---|---|---|
| cisplatinAlso: CDDP, PlatinolCisplatin administered intravenously, 75 mg/m^2 over 1-2 hours on day 1 of a 21 day cycle | Drug | Sorafenib/Pemetrexed/Cisplatin |
| pemetrexed disodiumAlso: Alimta, MTA, LY231514Pemetrexed 500 mg/m^2 intravenously (IV) will be given as a 10-minute intravenous infusion (after cisplatin) on day 1 of a 21 day cycle | Drug | Sorafenib/Pemetrexed/Cisplatin |
| sorafenibAlso: BAY 43-9006 tosylate, NSC 724772daily oral sorafenib (200 mg or 400 mg bid) | Drug | Sorafenib/Pemetrexed/Cisplatin |
Primary outcome
Maximum tolerated dose of sorafenib tosylate
Time frame: From first dose to toxicity event
This dose level is declared to be above the maximum tolerated dose (MTD) and dose escalation is stopped. Declare the next lower dose the MTD if 6 patients have already been treated at that dose.
2 secondary outcomes
Disease Response
Time frame: At 6- 8 weeks
Maximum, Minimum and AUC Concentrations of Sorafenib
Time frame: Day 1 to Day 8
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 29 Nov 2017.
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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.
Priya Kumar, MD principal investigator
Masonic Cancer Center, University of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing cisplatin, pemetrexed disodium and sorafenib in people with Breast Cancer and Colorectal Cancer, run by Masonic Cancer Center, University of Minnesota 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 21 inclusion and 21 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 29 Nov 2017. 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 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?
Maximum tolerated dose of sorafenib tosylate (time frame: From first dose to toxicity event). 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 29 Nov 2017.