Advanced CancersPhase 1NCT01532011
Erlotinib in Combination With Pralatrexate in Advanced Malignancies
A Phase 1 study testing Erlotinib and Pralatrexate in people with Advanced Cancers and Solid Tumors, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
The goal of this clinical research study is to find the highest tolerable dose of the combination of erlotinib and pralatrexate that can be given to patients with advanced cancer. The safety of the drug combination will also be studied. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Advanced Cancers, Solid Tumors
- What is being tested?
- Erlotinib and Pralatrexate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2012to Jun 2016
- 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 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Measurable or non-measurable disease.
- Patients with advanced cancer should be refractory to standard therapy, relapsed after standard therapy, or have no standard therapy that improves survival by at least three months.
- Patients must be at least 3 weeks after cytotoxic therapy and at least 5 half lives after their previous treatment or 3 weeks, whichever shorter, after biologic therapy. Patients may receive palliative radiotherapy immediately before or during treatment provided that not all target lesions are radiated.
- Eastern Cooperative Oncology Group (ECOG) performance status </= 2 (Karnofsky >/= 60%).
- Patients must have normal organ and marrow function defined as: absolute neutrophil count >/=1,000/mL; platelets >/=100,000/mL; creatinine < 2.0; total bilirubin < 2.0; ALT(SGPT) </=3 X upper limit of normal (ULN); Exception for patients with liver metastasis: ALT(SGPT) </= 5 X ULN.
- Women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 30 days after the last dose.
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- Ability to understand and the willingness to sign a written informed consent document.
- For the MTD expansion cohort, patients will be eligible if they meet one of the following criteria: I. Have an epidermal growth factor receptor (EGFR)-sensitive mutation (as G719C in exon 18, E746-A750 in exon 90, L858R in exon 21) and have been previously treated with EGFR inhibitor therapy but have subsequently developed resistance, OR II. Have an EGFR-resistant mutation (as T790M in exon 20), OR III. Do not have an EGFR mutation, but have benefited from EGFR inhibitor therapy (including either >/=4 months of stable disease [SD] OR a >/= partial response [PR]).
- Age >/= 12 years
Who cannot join
- Patients with uncontrolled concurrent illness, including but not limited to: ongoing or active infection requiring hospitalization; psychiatric illness/social situations that would limit compliance with study requirements.
- Exclusion of patients with creatinine >2.0 and bilirubin > 2.0.
- Patients with colorectal carcinoma with tumors that demonstrate a Kirsten rat sarcoma (KRAS) mutation.
- Pregnant or lactating women.
- Patients with a history of bone marrow transplant within the previous two years.
- Patients with a known hypersensitivity to any of the components of the drug products.
- Patients with major surgery within 30 days prior to entering the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
About this study
Official title: A Phase I Dose-Escalation Study of Erlotinib in Combination With Pralatrexate in Subjects With Advanced Cancer
The goal of this clinical research study is to find the highest tolerable dose of the combination of erlotinib and pralatrexate that can be given to patients with advanced cancer. The safety of the drug combination will also be studied.
Pralatrexate is designed to block the body's ability to make folic acid, a protein that may help cancer tissue to develop and spread.
Erlotinib hydrochloride is designed to block proteins that are thought to cause cancer cells to grow. Erlotinib may help slow the growth of tumors.
Read the detailed description
Study Groups:
If you are found to be eligible to take part in this study, you will be assigned to a dose level of erlotinib and pralatrexate based on when you join this study.
Dose Escalation:
Several dose levels of erlotinib and pralatrexate will be tested. Three (3) to 6 participants will start at the lowest planned doses of erlotinib and pralatrexate. Each new group of 3-6 participants will receive a higher dose than the group before it, if no intolerable side effects were seen. This will continue until the highest tolerable dose of erlotinib in combination with pralatrexate is found.
Dose Expansion:
Once the highest tolerable dose or most appropriate combination dose level is found, 10 more participants will take the study drugs at this dose level.
Study Drug Administration:
Each study cycle is 28 days.
Up to 10 days before you start treatment , you will start taking folic acid to help lower the risk of side effects. Although the study drug is designed to prevent the body from making folic acid that could help cancer grow and spread, some folic acid is needed to prevent side effects in non-cancerous tissue. You will take folic acid by mouth 1 time every day during treatment and for at least 30 days after you received the last dose of pralatrexate.
Up to 10 days before you start treatment, you will receive a vitamin B12 injection. You will receive an injection of Vitamin B12 about every 3 months after that.
On Days 1, 8, and 15 of each cycle, you will receive pralatrexate by vein over 3-5 minutes.
You will take erlotinib hydrochloride by mouth 1 time a day every day. You should take erlotinib hydrochloride on an empty stomach either 1 hour before eating or 2 hours after eating.
You will take erlotinib at home except on the days when you have a study visit. You should take it at about the same time each day with about a cup (8 ounces) of water.
Study Visits:
At every study visit, you will be asked about any current health conditions you have, any other drugs you are taking, and if you have had any side effects.
If the screening tests were performed within 7 days before Cycle 1, tests and procedures may not have to be repeated.
At any time during Cycle 1:
- You will have a physical exam, including measurement of your weight at least 1 time per cycle.
- Your vital signs will be measured.
- Your performance status will be recorded.
- Blood (about 2 teaspoons) will be drawn for routine tests and to see how well your blood clots.
- If you are taking part in the expansion phase, blood (about 2 teaspoons) will be drawn for pharmacodynamic (PD) testing.
At any time during Cycle 2:
- You will have a physical exam, including measurement of your weight at least 1 time per cycle.
- Your vital signs will be measured.
- Your performance status will be recorded.
- Blood (about 4 teaspoons) will be drawn for routine tests.
- If you are taking part in the expansion phase, blood (about 2 teaspoons) will be drawn for PD testing.
About every 8 weeks, you will have an x-ray, CT scan, MRI scan, and/or positron emission computed tomography (PET)/CT scan to check the status of the disease. Blood (about 1 teaspoon) may be drawn for tumor marker testing depending on the type of tumor. If the study doctor thinks it is needed, they will be performed more or less often.
At any time during Cycle 3 and beyond:
- You will have a physical exam, including measurement of your weight at least 1 time per cycle.
- Your vital signs will be measured.
- Your performance status will be recorded.
- Blood (about 2 teaspoons) will be drawn for routine tests.
Length of Dosing:
You may continue taking the study drugs for as long as the doctor thinks it is in your best interest. You will no longer be able to take the study drugs if the disease gets worse, if intolerable side effects occur, or if you are unable to follow study directions.
Your participation on the study will be over once you have completed the end-of-treatment and follow-up visits.
End of Dosing Visit:
After you are finished taking the study drugs:
- You will have a physical exam, including measurement of your weight and vital signs.
- Your performance status will be recorded.
- Blood (about 2 teaspoons) and urine will be collected for routine tests.
This is an investigational study. Pralatrexate is FDA approved and commercially available for the treatment of cutaneous T-cell lymphoma (CTCL) and peripheral T-cell lymphoma (PTCL). Erlotinib is FDA approved and commercially available for the treatment of pancreatic cancer and non small cell lung cancer (NSCLC). The study drug combination is investigational.
Up to 74 patients will take part in this study. All will be enrolled at MD Anderson.
- Conditions
- Advanced Cancers, Solid Tumors
- Being tested
- Erlotinib, Pralatrexate
- Keywords
- Advanced Cancers, Solid Tumors, Erlotinib, Erlotinib Hydrochloride, OSI-774, Tarceva, Pralatrexate, Folotyn, PDX-010
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ErlotinibDrug
Also called Erlotinib Hydrochloride, OSI-774, Tarceva
Dose escalation group starting dose: 75 mg by mouth daily for a 28 day cycle.
Dose expansion group starting dose: Maximum tolerated dose (MTD) from dose escalation group.
PralatrexateDrug
Also called Folotyn, PDX-010
Dose escalation group starting dose: 15 mg/m2 by vein on days 1, 8, and 15 of a 28 day cycle.
Dose expansion group starting dose: Maximum tolerated dose (MTD) from dose escalation group.
| Study group | Role | What they receive |
|---|---|---|
| Erlotinib + Pralatrexate | Experimental | Dose escalation group starting dose: Erlotinib 75 mg by mouth daily for a 28 day cycle. Starting dose of Pralatrexate 15 mg/m2 by vein on days 1, 8, and 15 of a 28 day cycle.
Dose expansion group starting dose: Maximum tolerated dose (MTD) from dose escalation group. Receives: Drug: Erlotinib; Drug: Pralatrexate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Tolerated Dose (MTD) of Erlotinib with Pralatrexate
MTD defined by dose limiting toxicities (DLTs) that occur in the first cycle. DLT defined as any Grade 3 or 4 non-hematologic toxicity as defined in the NCI Common Toxicity Criteria for Adverse Effects (CTCAE) v3.0. Grade 4 hematologic toxicity lasting 2 weeks or longer despite supportive care. Grade 4 nausea or vomiting > 5 days despite maximum anti-nausea regimens, and any other Grade 3 non-hematologic toxicity, including symptoms/signs of vascular leak or cytokine release syndrome; or any severe or life-threatening complication or abnormality not defined in NCI-CTCAE as attributable to therapy.
Measured: 8 weeks
Secondary outcomes (1)
Tumor Response
Tumor response defined as one or more of the following: (1) stable disease for more than or equal to 4 months, (2) decrease in measurable tumor (sentinel lesions) by more than or equal to 20% by Response Evaluation Criteria in Solid Tumors (RECIST) criteria, (3) decrease in tumor markers by more than or equal to 25% (for example, a >/= 25% decrease in CA125 for patients with ovarian cancer), or (4) a partial response according to the Choi criteria, i.e. decrease in size by 10% or more, or a decrease in tumor density, as measured in Hounsfield units (HU), by more than or equal to 15% (28).
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2012 (estimated)
- Study startMar 2012
- Primary completionJun 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced CancersStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe 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
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Shumei Kato, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01532011
- Sponsor's protocol ID
- 2011-0916
- Other IDs
- NCI-2012-00219
- Status last verified
- Jul 2016
- First submitted
- 9 Feb 2012
- Last updated
- 4 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Dose-Escalation Study of Erlotinib in Combination With Pralatrexate in Subjects With Advanced Cancer
- ClinicalTrials.gov ID
- NCT01532011
- Acronym / sponsor ID
- 2011-0916
- Conditions
- Advanced Cancers, Solid Tumors
- Keywords
- Advanced Cancers, Solid Tumors, Erlotinib, Erlotinib Hydrochloride, OSI-774, Tarceva, Pralatrexate, Folotyn
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- Mar 2012
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 13 Feb 2012 (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.
The goal of this clinical research study is to find the highest tolerable dose of the combination of erlotinib and pralatrexate that can be given to patients with advanced cancer. The safety of the drug combination will also be studied.
Pralatrexate is designed to block the body's ability to make folic acid, a protein that may help cancer tissue to develop and spread.
Erlotinib hydrochloride is designed to block proteins that are thought to cause cancer cells to grow. Erlotinib may help slow the growth of tumors.
Detailed description
Study Groups:
If you are found to be eligible to take part in this study, you will be assigned to a dose level of erlotinib and pralatrexate based on when you join this study.
Dose Escalation:
Several dose levels of erlotinib and pralatrexate will be tested. Three (3) to 6 participants will start at the lowest planned doses of erlotinib and pralatrexate. Each new group of 3-6 participants will receive a higher dose than the group before it, if no intolerable side effects were seen. This will continue until the highest tolerable dose of erlotinib in combination with pralatrexate is found.
Dose Expansion:
Once the highest tolerable dose or most appropriate combination dose level is found, 10 more participants will take the study drugs at this dose level.
Study Drug Administration:
Each study cycle is 28 days.
Up to 10 days before you start treatment , you will start taking folic acid to help lower the risk of side effects. Although the study drug is designed to prevent the body from making folic acid that could help cancer grow and spread, some folic acid is needed to prevent side effects in non-cancerous tissue. You will take folic acid by mouth 1 time every day during treatment and for at least 30 days after you received the last dose of pralatrexate.
Up to 10 days before you start treatment, you will receive a vitamin B12 injection. You will receive an injection of Vitamin B12 about every 3 months after that.
On Days 1, 8, and 15 of each cycle, you will receive pralatrexate by vein over 3-5 minutes.
You will take erlotinib hydrochloride by mouth 1 time a day every day. You should take erlotinib hydrochloride on an empty stomach either 1 hour before eating or 2 hours after eating.
You will take erlotinib at home except on the days when you have a study visit. You should take it at about the same time each day with about a cup (8 ounces) of water.
Study Visits:
At every study visit, you will be asked about any current health conditions you have, any other drugs you are taking, and if you have had any side effects.
If the screening tests were performed within 7 days before Cycle 1, tests and procedures may not have to be repeated.
At any time during Cycle 1:
- You will have a physical exam, including measurement of your weight at least 1 time per cycle.
- Your vital signs will be measured.
- Your performance status will be recorded.
- Blood (about 2 teaspoons) will be drawn for routine tests and to see how well your blood clots.
- If you are taking part in the expansion phase, blood (about 2 teaspoons) will be drawn for pharmacodynamic (PD) testing.
At any time during Cycle 2:
- You will have a physical exam, including measurement of your weight at least 1 time per cycle.
- Your vital signs will be measured.
- Your performance status will be recorded.
- Blood (about 4 teaspoons) will be drawn for routine tests.
- If you are taking part in the expansion phase, blood (about 2 teaspoons) will be drawn for PD testing.
About every 8 weeks, you will have an x-ray, CT scan, MRI scan, and/or positron emission computed tomography (PET)/CT scan to check the status of the disease. Blood (about 1 teaspoon) may be drawn for tumor marker testing depending on the type of tumor. If the study doctor thinks it is needed, they will be performed more or less often.
At any time during Cycle 3 and beyond:
- You will have a physical exam, including measurement of your weight at least 1 time per cycle.
- Your vital signs will be measured.
- Your performance status will be recorded.
- Blood (about 2 teaspoons) will be drawn for routine tests.
Length of Dosing:
You may continue taking the study drugs for as long as the doctor thinks it is in your best interest. You will no longer be able to take the study drugs if the disease gets worse, if intolerable side effects occur, or if you are unable to follow study directions.
Your participation on the study will be over once you have completed the end-of-treatment and follow-up visits.
End of Dosing Visit:
After you are finished taking the study drugs:
- You will have a physical exam, including measurement of your weight and vital signs.
- Your performance status will be recorded.
- Blood (about 2 teaspoons) and urine will be collected for routine tests.
This is an investigational study. Pralatrexate is FDA approved and commercially available for the treatment of cutaneous T-cell lymphoma (CTCL) and peripheral T-cell lymphoma (PTCL). Erlotinib is FDA approved and commercially available for the treatment of pancreatic cancer and non small cell lung cancer (NSCLC). The study drug combination is investigational.
Up to 74 patients will take part in this study. All will be enrolled at MD Anderson.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Erlotinib + Pralatrexate | Experimental | Drug: Erlotinib, Drug: PralatrexateDose escalation group starting dose: Erlotinib 75 mg by mouth daily for a 28 day cycle. Starting dose of Pralatrexate 15 mg/m2 by vein on days 1, 8, and 15 of a 28 day cycle. Dose expansion group starting dose: Maximum tolerated dose (MTD) from dose escalation group. |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (9 listed)
- Measurable or non-measurable disease.
- Patients with advanced cancer should be refractory to standard therapy, relapsed after standard therapy, or have no standard therapy that improves survival by at least three months.
- Patients must be at least 3 weeks after cytotoxic therapy and at least 5 half lives after their previous treatment or 3 weeks, whichever shorter, after biologic therapy. Patients may receive palliative radiotherapy immediately before or during treatment provided that not all target lesions are radiated.
- Eastern Cooperative Oncology Group (ECOG) performance status </= 2 (Karnofsky >/= 60%).
- Patients must have normal organ and marrow function defined as: absolute neutrophil count >/=1,000/mL; platelets >/=100,000/mL; creatinine < 2.0; total bilirubin < 2.0; ALT(SGPT) </=3 X upper limit of normal (ULN); Exception for patients with liver metastasis: ALT(SGPT) </= 5 X ULN.
Key exclusion criteria (7 listed)
- Patients with uncontrolled concurrent illness, including but not limited to: ongoing or active infection requiring hospitalization; psychiatric illness/social situations that would limit compliance with study requirements.
- Exclusion of patients with creatinine >2.0 and bilirubin > 2.0.
- Patients with colorectal carcinoma with tumors that demonstrate a Kirsten rat sarcoma (KRAS) mutation.
- Pregnant or lactating women.
- Patients with a history of bone marrow transplant within the previous two years.
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 |
|---|---|---|
| ErlotinibAlso: Erlotinib Hydrochloride, OSI-774, TarcevaDose escalation group starting dose: 75 mg by mouth daily for a 28 day cycle. Dose expansion group starting dose: Maximum tolerated dose (MTD) from dose escalation group. | Drug | Erlotinib + Pralatrexate |
| PralatrexateAlso: Folotyn, PDX-010Dose escalation group starting dose: 15 mg/m2 by vein on days 1, 8, and 15 of a 28 day cycle. Dose expansion group starting dose: Maximum tolerated dose (MTD) from dose escalation group. | Drug | Erlotinib + Pralatrexate |
Primary outcome
Maximum Tolerated Dose (MTD) of Erlotinib with Pralatrexate
Time frame: 8 weeks
MTD defined by dose limiting toxicities (DLTs) that occur in the first cycle. DLT defined as any Grade 3 or 4 non-hematologic toxicity as defined in the NCI Common Toxicity Criteria for Adverse Effects (CTCAE) v3.0. Grade 4 hematologic toxicity lasting 2 weeks or longer despite supportive care. Grade 4 nausea or vomiting > 5 days despite maximum anti-nausea regimens, and any other Grade 3 non-hematologic toxicity, including symptoms/signs of vascular leak or cytokine release syndrome; or any severe or life-threatening complication or abnormality not defined in NCI-CTCAE as attributable to therapy.
1 secondary outcome
Tumor Response
Time frame: 8 weeks
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 4 Jul 2016.
- University of Texas MD Anderson Cancer Center WebsiteLink 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.
Shumei Kato, MD principal investigator
M.D. Anderson Cancer Center
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 Erlotinib and Pralatrexate in people with Advanced Cancers and Solid Tumors, run by M.D. Anderson Cancer Center 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 9 inclusion and 7 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 4 Jul 2016. 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 (MTD) of Erlotinib with Pralatrexate (time frame: 8 weeks). 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 4 Jul 2016.