Lung CancerPhase 1/2NCT00387322
Pemetrexed Disodium and Erlotinib in Treating Patients With Advanced Non-Small Cell Lung Cancer or Other Solid Tumors
A Phase 1/2 study testing erlotinib hydrochloride and pemetrexed disodium in people with Lung Cancer and Unspecified Adult Solid Tumor, Protocol Specific, run by University of California, Davis at 1 site in United States.
Trial summary
RATIONALE: Pemetrexed disodium and erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving pemetrexed disodium together with erlotinib may kill more tumor cells. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer, Unspecified Adult Solid Tumor, Protocol Specific
- What is being tested?
- erlotinib hydrochloride and pemetrexed disodium
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2005to May 2009
- Phase
- Phase 1/2
- 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
- For the phase I portion of the study patients must have cytologically or histologically proven advanced solid tumors for which there is no standard effective therapy available. For the phase II portion patients must have cytologically or histologically proven selected stage IIIB (pleural effusion) or IV NSCLC. Patients with NSCLC that have progressed or recurred after first-line therapy for stage IIIA or IIIB may also be considered.
- For the phase II portion patients must have disease that has progressed or recurred after treatment with platinum-based therapy.
- Any number of prior chemotherapy regimens are allowed for the phase I portion and no more than 1 previous treatment for advanced NSCLC is allowed for the phase II portion.
- Patients must have measurable disease by RECIST criteria. Disease in previously irradiated sites is considered measurable if there is clear disease progression following radiation therapy. Patients with evaluable disease (bone metastases, pleural fluid, ascites, etc.) may be included in the phase I portion of the trial.
- Patients must be 18 years of age or older.
- Patients must have a performance status of 0-2 for phase I portion of study and a performance status of 0 -1 for the phase II portion of the trial.
Show all 16Show fewer
- Patients must have an estimated survival of at least 3 months.
- Any prior chemotherapy that patients have received has to have been completed at least 4 weeks prior to start of treatment. For prior mitomycin chemotherapy a 6-week interval is required. Prior radiation must have been completed at least 2 weeks prior to start of therapy. Patients must have recovered from acute reversible side effects of prior chemotherapy regimens or radiotherapy to NCI-CTC < grade 1 (excluding alopecia).
- Patients must have adequate renal function as documented by a serum creatinine < 1.5 mg/dl or a calculated creatinine clearance of > 45 ml/min (see appendix for formula for calculating creatinine clearance).
- Patients must have adequate liver function as documented by serum bilirubin < 1.5 x ULN. AST must be < 2.5 x institutional upper limit of normal.
- Patients must have a pretreatment granulocyte count of >1500/mm3 and platelet count of >100 000/mm3.
- 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. Because of the possibility of treatment related neurological toxicity it is difficult to evaluate for toxicity in the presence of symptomatic brain metastasis.
- All patients must give voluntary written informed consent.
- Patients must be able to take and retain oral medication.
- 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.
- Patients on coumadin should have their INR monitored at least once per week or more frequently depending on the investigators judgement. There have been some case reports of increased INR when coumadin is co-administered with OSI-774/placebo.
Who cannot join
- Patients may not have previously received Pemetrexed or an EGFR-directed therapy.
- Females can not be pregnant or breastfeeding as the effects of these drugs on the unborn fetus are unknown. Documentation of a negative serum pregnancy test is required for all women of reproductive potential.
- Patients with symptomatic brain metastasis or still requiring steroids and anti-convulsants may not be included.
- No other prior malignancy is allowed for the phase II portion except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease-free for over five years.
- Patients cannot take non-steroidal anti-inflammatory agents (NSAIDS) or salicylates 2 days prior and 2 days following (5 days pre and post for long-acting NSAIDS) administration of pemetrexed due to concerns of increased risk of renal toxicity.
- Patients with clinically significant ophthalmologic abnormalities will be excluded. This includes severe dry eye syndrome, keratoconjunctivitis sicca, Sjogren's syndrome, severe exposure keratopathy, or other disorders that might increase the risk of corneal epithelial injury.
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 Study of Two Different Schedules of Pemetrexed (ALIMTA) and Erlotinib (TARCEVA) in Advanced Solid Tumors, With Emphasis on Non-Small Cell Lung Cancer (NSCLC)
RATIONALE: Pemetrexed disodium and erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving pemetrexed disodium together with erlotinib may kill more tumor cells.
PURPOSE: This phase I/II trial is studying the side effects and best dose of two different schedules of pemetrexed disodium and erlotinib and to see how well they work in treating patients with advanced non-small cell lung cancer or other solid tumors.
Read the detailed description
OBJECTIVES:
Primary
- Determine the safety and feasibility of combining pemetrexed disodium with erlotinib hydrochloride in patients with advanced non-small lung cancer (NSCLC) or other solid tumors. (Phase I)
- Determine the response rate in patients with NSCLC treated with pemetrexed disodium in combination with erlotinib hydrochloride. (Phase II)
Secondary
- Compare toxicity differences between different schedules of pemetrexed disodium and erlotinib hydrochloride. (Phase I)
- Determine the maximum tolerated dose (MTD) of 2 different schedules of pemetrexed disodium and erlotinib hydrochloride. (Phase I)
- Determine, preliminarily, the efficacy of the combination of pemetrexed disodium and erlotinib hydrochloride in patients with advanced solid tumors. (Phase I)
- Assess the overall survival and progression-free survival. (Phase II)
- Determine the frequency and severity of toxicities associated with the administration of pemetrexed disodium and erlotinib hydrochloride. (Phase II)
OUTLINE: This is a multicenter, phase I dose-escalation study followed by a phase II open-label study.
- Phase I: Patients are assigned to 1 of 2 treatment groups in an alternating fashion. Once accrual to the first dose level in group 1 is complete, group 2 will open for accrual to its first dose level.
- Group 1: Patients receive oral erlotinib hydrochloride once on days 2, 9, and 16 and pemetrexed disodium IV over 10 minutes on day 1. Treatment repeats every 21 days for 6 courses in the absence of unacceptable toxicity or disease progression.
- Group 2: Patients receive oral erlotinib hydrochloride once daily on days 2-16 and pemetrexed disodium IV over 10 minutes on day 1. Treatment repeats every 21 days for 6 courses in the absence of unacceptable toxicity or disease progression.
In both groups, patients may continue to receive erlotinib hydrochloride alone after completion of 6 courses of erlotinib hydrochloride in combination with pemetrexed disodium.
In both groups, cohorts of 3-6 patients receive escalating doses of erlotinib hydrochloride and pemetrexed disodium 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 at the MTD and erlotinib hydrochloride at the MTD as in group 1 or 2 (whichever is more favorable).
After completion of study treatment, patients are followed periodically.
PROJECTED ACCRUAL: A total of 92 patients will be accrued for this study.
- Being tested
- erlotinib hydrochloride, pemetrexed disodium
- Keywords
- unspecified adult solid tumor, protocol specific, recurrent non-small cell lung cancer, stage IIIB non-small cell lung cancer, stage IV non-small cell lung cancer
- Medical subject headings
- Lung Neoplasms, Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
erlotinib hydrochlorideDrug
Also called Tarceva
Given orally
pemetrexed disodiumDrug
Also called Alimta
Given IV
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | Patients receive oral erlotinib hydrochloride once on days 2, 9, and 16 and pemetrexed disodium IV over 10 minutes on day 1. Treatment repeats every 21 days for 6 courses in the absence of unacceptable toxicity or disease progression Receives: Drug: erlotinib hydrochloride; Drug: pemetrexed disodium |
| Group 2 | Experimental | Patients receive oral erlotinib hydrochloride once daily on days 2-16 and pemetrexed disodium IV over 10 minutes on day 1. Treatment repeats every 21 days for 6 courses in the absence of unacceptable toxicity or disease progression. Receives: Drug: erlotinib hydrochloride; Drug: pemetrexed disodium |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and feasibility (Phase I)
Measured: October 2007
Response rate (Phase II)
Measured: Phase II not performed
Secondary outcomes (6)
Toxicity (Phase I)
Measured: October 2007
Maximum tolerated dose (Phase I)
Measured: October 2007
Preliminary efficacy (Phase I)
Measured: October 2007
Overall survival (Phase II)
Measured: Phase II not performed
Progression-free survival (Phase II)
Measured: Phase II not performed
Frequency and severity of toxicity (Phase II)
Measured: Phase II not performed
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2006 (estimated)
- Study startMar 2005
- Primary completionOct 2007
- Study completionMay 2009
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.
- More trials run by University of California, DavisThe 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Davis
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- David Gandara, MD, Study chair, University of California, Davis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00387322
- Sponsor's protocol ID
- CDR0000505895
- Other IDs
- P30CA093373, UCDCC-159, 200412741
- Status last verified
- Mar 2010
- First submitted
- 12 Oct 2006
- Last updated
- 29 Mar 2010
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Davies AM, Ho C, Beckett L, Lau D, Scudder SA, Lara PN, Perkins N, Gandara DR. Intermittent erlotinib in combination with pemetrexed: phase I schedules designed to achieve pharmacodynamic separation. J Thorac Oncol. 2009 Jul;4(7):862-8. doi: 10.1097/JTO.0b013e3181a94b08.
PubMed 19494788
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I/II Study of Two Different Schedules of Pemetrexed (ALIMTA) and Erlotinib (TARCEVA) in Advanced Solid Tumors, With Emphasis on Non-Small Cell Lung Cancer (NSCLC)
- ClinicalTrials.gov ID
- NCT00387322
- Acronym / sponsor ID
- CDR0000505895
- Keywords
- unspecified adult solid tumor, protocol specific, recurrent non-small cell lung cancer, stage IIIB non-small cell lung cancer, stage IV non-small cell lung cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Mar 2005
- Primary completion
- Oct 2007 (actual)
- Study completion
- May 2009 (actual)
- First posted
- 13 Oct 2006 (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: Pemetrexed disodium and erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving pemetrexed disodium together with erlotinib may kill more tumor cells.
PURPOSE: This phase I/II trial is studying the side effects and best dose of two different schedules of pemetrexed disodium and erlotinib and to see how well they work in treating patients with advanced non-small cell lung cancer or other solid tumors.
Detailed description
OBJECTIVES:
Primary
- Determine the safety and feasibility of combining pemetrexed disodium with erlotinib hydrochloride in patients with advanced non-small lung cancer (NSCLC) or other solid tumors. (Phase I)
- Determine the response rate in patients with NSCLC treated with pemetrexed disodium in combination with erlotinib hydrochloride. (Phase II)
Secondary
- Compare toxicity differences between different schedules of pemetrexed disodium and erlotinib hydrochloride. (Phase I)
- Determine the maximum tolerated dose (MTD) of 2 different schedules of pemetrexed disodium and erlotinib hydrochloride. (Phase I)
- Determine, preliminarily, the efficacy of the combination of pemetrexed disodium and erlotinib hydrochloride in patients with advanced solid tumors. (Phase I)
- Assess the overall survival and progression-free survival. (Phase II)
- Determine the frequency and severity of toxicities associated with the administration of pemetrexed disodium and erlotinib hydrochloride. (Phase II)
OUTLINE: This is a multicenter, phase I dose-escalation study followed by a phase II open-label study.
- Phase I: Patients are assigned to 1 of 2 treatment groups in an alternating fashion. Once accrual to the first dose level in group 1 is complete, group 2 will open for accrual to its first dose level.
- Group 1: Patients receive oral erlotinib hydrochloride once on days 2, 9, and 16 and pemetrexed disodium IV over 10 minutes on day 1. Treatment repeats every 21 days for 6 courses in the absence of unacceptable toxicity or disease progression.
- Group 2: Patients receive oral erlotinib hydrochloride once daily on days 2-16 and pemetrexed disodium IV over 10 minutes on day 1. Treatment repeats every 21 days for 6 courses in the absence of unacceptable toxicity or disease progression.
In both groups, patients may continue to receive erlotinib hydrochloride alone after completion of 6 courses of erlotinib hydrochloride in combination with pemetrexed disodium.
In both groups, cohorts of 3-6 patients receive escalating doses of erlotinib hydrochloride and pemetrexed disodium 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 at the MTD and erlotinib hydrochloride at the MTD as in group 1 or 2 (whichever is more favorable).
After completion of study treatment, patients are followed periodically.
PROJECTED ACCRUAL: A total of 92 patients will be accrued for this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Drug: erlotinib hydrochloride, Drug: pemetrexed disodiumPatients receive oral erlotinib hydrochloride once on days 2, 9, and 16 and pemetrexed disodium IV over 10 minutes on day 1. Treatment repeats every 21 days for 6 courses in the absence of unacceptable toxicity or disease progression |
| Group 2 | Experimental | Drug: erlotinib hydrochloride, Drug: pemetrexed disodiumPatients receive oral erlotinib hydrochloride once daily on days 2-16 and pemetrexed disodium IV over 10 minutes on day 1. Treatment repeats every 21 days for 6 courses in the absence of unacceptable toxicity or disease progression. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- For the phase I portion of the study patients must have cytologically or histologically proven advanced solid tumors for which there is no standard effective therapy available. For the phase II portion patients must have cytologically or histologically proven selected stage IIIB (pleural effusion) or IV NSCLC. Patients with NSCLC that have progressed or recurred after first-line therapy for stage IIIA or IIIB may also be considered.
- For the phase II portion patients must have disease that has progressed or recurred after treatment with platinum-based therapy.
- Any number of prior chemotherapy regimens are allowed for the phase I portion and no more than 1 previous treatment for advanced NSCLC is allowed for the phase II portion.
- Patients must have measurable disease by RECIST criteria. Disease in previously irradiated sites is considered measurable if there is clear disease progression following radiation therapy. Patients with evaluable disease (bone metastases, pleural fluid, ascites, etc.) may be included in the phase I portion of the trial.
- Patients must be 18 years of age or older.
Key exclusion criteria (6 listed)
- Patients may not have previously received Pemetrexed or an EGFR-directed therapy.
- Females can not be pregnant or breastfeeding as the effects of these drugs on the unborn fetus are unknown. Documentation of a negative serum pregnancy test is required for all women of reproductive potential.
- Patients with symptomatic brain metastasis or still requiring steroids and anti-convulsants may not be included.
- No other prior malignancy is allowed for the phase II portion except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease-free for over five years.
- Patients cannot take non-steroidal anti-inflammatory agents (NSAIDS) or salicylates 2 days prior and 2 days following (5 days pre and post for long-acting NSAIDS) administration of pemetrexed due to concerns of increased risk of renal toxicity.
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 |
|---|---|---|
| erlotinib hydrochlorideAlso: TarcevaGiven orally | Drug | Group 1, Group 2 |
| pemetrexed disodiumAlso: AlimtaGiven IV | Drug | Group 1, Group 2 |
Primary outcome
Safety and feasibility (Phase I)
Time frame: October 2007
Response rate (Phase II)
Time frame: Phase II not performed
6 secondary outcomes
Toxicity (Phase I)
Time frame: October 2007
Maximum tolerated dose (Phase I)
Time frame: October 2007
Preliminary efficacy (Phase I)
Time frame: October 2007
Overall survival (Phase II)
Time frame: Phase II not performed
Progression-free survival (Phase II)
Time frame: Phase II not performed
Frequency and severity of toxicity (Phase II)
Time frame: Phase II not performed
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 Mar 2010.
- Results publication: PubMed 19494788Davies AM, Ho C, Beckett L, Lau D, Scudder SA, Lara PN, Perkins N, Gandara DR. Intermittent erlotinib in combination with pemetrexed: phase I schedules designed to achieve pharmacodynamic separation. J Thorac Oncol. 2009 Jul;4(7):862-8. doi: 10.1097/JTO.0b013e3181a94b08.
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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 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 erlotinib hydrochloride and pemetrexed disodium in people with Lung Cancer and Unspecified Adult Solid Tumor, Protocol Specific, 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 16 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Mar 2010. 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?
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?
Safety and feasibility (Phase I) (time frame: October 2007). 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 NCT00387322, 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 29 Mar 2010.