Ovarian CancerPhase 1/2NCT00489359
Trial of Pemetrexed and Carboplatin in Patients With Recurrent Ovarian or Primary Peritoneal Cancer
A Phase 1/2 study testing Pemetrexed - Phase 1, Carboplatin - Phase 1 and Pemetrexed - Phase 2 in people with Ovarian Cancer and Primary Peritoneal Cancer, run by Eli Lilly and Company at 22 sites in 5 countries.
Trial summary
The purpose of this study is to determine efficacy of the combination therapy of pemetrexed and carboplatin as treatment for patients with platinum-sensitive ovarian cancer. This study also includes patients with primary peritoneal cancer. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Ovarian Cancer, Primary Peritoneal Cancer
- What is being tested?
- Pemetrexed - Phase 1, Carboplatin - Phase 1 and Pemetrexed - Phase 2
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- 22 sitesin 5 countries
- Study dates
- Jul 2005to Feb 2010
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of ovarian or primary peritoneal cancer confirmed by pathology
- Patients must have recurrent ovarian cancer which is sensitive to platinum therapy
- Prior radiation therapy is allowed
- Measurable disease as defined by the Response Evaluation Criteria In Solid Tumors (RECIST) guidelines, or non-measurable but cancer antigen 125 (CA-125) greater than or equal to 2X upper limit.
Who cannot join
- More than 2 lines of therapy for ovarian or primary peritoneal cancer.
- Pregnant or breast feeding.
- Have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry.
Trial locations and contacts
22 sites in 5 countries.
22 sites in 5 countries
Germany11 sites
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Berlin, 13353
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Bonn, 53127
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Chemnitz, D-09116
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Düsseldorf, 40489
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Erlangen, D-91054
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Essen, DE-45145
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Hamburg, 22081
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Jena, D-07743
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Kiel, D-24105
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Mainz, 55131
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Tübingen, 72076
Argentina4 sites
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Bahía Blanca, B8000HXM
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Buenos Aires, C1199ACK
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Ramos Mejía, B1704ESN
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Salta, 4400
Poland3 sites
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Gdansk, 80-402
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Olsztyn, 10-228
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Warsaw, 00909
Canada2 sites
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Calgary, Alberta, T2N 4N2
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Toronto, Ontario, M5G 2M9
Sweden2 sites
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Gothenburg, 416 85
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Lund, 22241
About this study
Official title: A Phase 1 and 2 Clinical Trial of ALIMTA® (Pemetrexed) in Combination With Carboplatin in Patients With Recurrent Ovarian or Primary Peritoneal Cancer
The purpose of this study is to determine efficacy of the combination therapy of pemetrexed and carboplatin as treatment for patients with platinum-sensitive ovarian cancer. This study also includes patients with primary peritoneal cancer.
- Conditions
- Ovarian Cancer, Primary Peritoneal Cancer
- Being tested
- Pemetrexed - Phase 1, Carboplatin - Phase 1, Pemetrexed - Phase 2, Carboplatin - Phase 2
- Medical subject headings
- Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pemetrexed - Phase 1Drug
Also called LY231514, Alimta
500, 600, 700, 800, or 900 milligrams per square meter (mg/m^2), administered intravenously (IV), every 21 days x 6 cycles, dose escalate to Maximum Tolerated Dose (MTD)
Carboplatin - Phase 1Drug
area under the concentration time curve (AUC) 5 or 6 mg/mL*min, administered intravenously (IV), every 21 days x 6 cycles, dose escalation to Maximum Tolerated Dose (MTD)
Pemetrexed - Phase 2Drug
Also called LY231514, Alimta
Dose determined from Phase 1: 500 mg/m^2, administered IV, every 21 days x 6 cycles
Carboplatin - Phase 2Drug
Dose determined from Phase 1: AUC 6 mg/mL*min, administered IV, every 21 days x 6 cycles
| Study group | Role | What they receive |
|---|---|---|
| Pemetrexed/Carboplatin Phase 1 | Experimental | Pemetrexed was administered intravenously over approximately 10 minutes on Day 1 of a 21-day cycle.
Carboplatin was administered intravenously over approximately 30 minutes on Day 1 of a 21-day cycle, beginning approximately 30 minutes after the end of the pemetrexed infusion. Receives: Drug: Pemetrexed - Phase 1; Drug: Carboplatin - Phase 1 |
| Pemetrexed/Carboplatin Phase 2 | Experimental | Pemetrexed was administered intravenously over approximately 10 minutes on Day 1 of a 21-day cycle.
Carboplatin was administered intravenously over approximately 30 minutes on Day 1 of a 21-day cycle, beginning approximately 30 minutes after the end of the pemetrexed infusion. Receives: Drug: Pemetrexed - Phase 2; Drug: Carboplatin - Phase 2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase 1 - Maximum Tolerated Dose (MTD) of Pemetrexed in Combination With Carboplatin
MTD was to be determined by increasing doses of pemetrexed up to 900 mg/m^2 and carboplatin Area Under the Concentration-Time Curve (AUC) up to 6 mg/mL*min based on observed pattern of dose limiting toxicity (DLT). See Outcome #3 for DLT. If none of 3 initial participants at a given level experienced a DLT in Cycle 1, enrollment proceeded to the next dose level. If at least 2 participants experienced a DLT in Cycle 1 at a dose level, that dose level was considered the MTD. However, based on results from a different Phase 2 Study (NCT00109096), further dose escalations were not explored.
Measured: First treatment to toxicity (up to 18 months)
Phase 2 - Percentage of Participants With Overall Tumor Response (Response Rate)
Response is defined as CR (Complete Response) or PR (Partial Response) per Response Evaluation Criteria in Solid Tumor (RECIST criteria). Possible evaluations include: CR: Disappearance of all target lesions. PR: At least a 30% decrease in the size of target lesions.
Response rate (%) = (number of patients with CR+PR/number of patients in Phase 2)*100
Measured: baseline to measured progressive disease (PD) (up to 18 months)
Secondary outcomes (12)
Phase 1 - Number of Dose-Limiting Toxicities (DLTs)
The following toxicities were considered DLT: CTCAE Grade 4 neutropenia (absolute neutrophil count [ANC] <0.5 × 10^9/L lasting ≥7 days. Febrile neutropenia (ANC <1.0 × 10^9/L, fever 38.5°C, and no documented infection). CTCAE Grade 4 thrombocytopenia (platelets <25.0 × 10^9/L).
Any hemorrhage with CTCAE Grade ≥3 thrombocytopenia (50.0 × 10^9/L). CTCAE Grade ≥3 nonhematologic toxicity (excluding nausea, vomiting, or CTCAE Grade 3 alanine transaminase (ALT) or aspartate aminotransferase (AST) that returned to baseline prior to next treatment).
Treatment delay more than 1 week due to toxicity.
Measured: baseline through end of Phase 1 (up to 18 months)
Phase 1 - Number of Participants With Adverse Events (Toxicity)
A listing of adverse events is located in the Reported Adverse Event module.
Measured: baseline measured to progressive disease (up to 18 months)
Phase 1 - Recommended Dose of Pemetrexed for Phase 2
MTD was to be used as Phase 2 recommended dose. MTD was to be determined by increasing doses of pemetrexed up to 900 mg/m^2 based on observed pattern of dose limiting toxicity (DLT: See Outcome #3). If none of 3 initial participants at a given level had a DLT in Cycle 1, enrollment proceeded to next dose level. If at least 2 participants had a DLT in Cycle 1 at a dose level, that dose level was considered the MTD. However, based on results from another Phase 2 Study (NCT00109096), further dose escalations were not explored and dose was selected based on results of that Phase 2 Study.
Measured: baseline measured to progressive disease (up to 18 months)
Phase 1 - Recommended Area Under the Curve (AUC) Dose of Carboplatin for Phase 2
MTD was to be used as Phase 2 recommended dose. MTD determined by increasing doses up to AUC 6 mg/mL*min based on pattern of DLT (Outcome #3). If none of 3 initial participants at given level had DLT in Cycle 1, enrollment proceeded to next dose level. If at least 2 participants had DLT in Cycle 1 at dose level, that dose level was considered MTD. However, based on results from Phase 2 Study (NCT00109096), further dose escalations were not explored: carboplatin dose was selected based on standard dose employed in control arm of first-line therapy for epithelial ovarian cancer (Bookman 2006).
Measured: baseline measured to progressive disease (up to 18 months)
Phase 1 - Number of Participants With Tumor Response
Patients were analyzed by Cancer Antigen-125 (CA-125) response criteria and RECIST guidelines. Possible evaluations include: Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): At least a 30% decrease in the size of target lesions. Progressive Disease (PD): At least a 20% increase in the size of target lesions. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD.
Measured: baseline measured to progressive disease (up to 18 months)
Phase 2 - Time to Response (TTR)
Response is defined as CR (Complete Response) or PR (Partial Response) per RECIST criteria. Possible evaluations include: Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): At least a 30% decrease in the size of target lesions. Progressive Disease (PD): At least a 20% increase in the size of target lesions. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD.
Measured: First treatment to response (up to 31 months)
Phase 2 - Duration of Response (DOR)
Duration of response is defined as the time from first observation of Complete Response or Partial Response to the first observation of Progressive Disease or death from any cause. For patients who are still alive at the time of analysis, and who do not have Progressive Disease, duration of response will be censored at the date of the last objective progression-free disease assessment.
Measured: time of response to progressive disease (up to 31 months)
Phase 2 - Time to Disease Progression
Time to objective progressive disease (TTPD) is defined as the time from the date of study enrollment to the date of objectively determined Progressive Disease (PD). For patients who die without objective PD (including death from study disease), TTPD will be censored at the date of the last objective progression-free disease assessment. For patients who are still alive at the time of analysis, and who do not have PD, TTPD will be censored at the date of the last objective progression-free disease assessment.
Measured: baseline to measured progressive disease (up to 31 months)
Phase 2 - Time to Treatment Failure
Time to treatment failure (TTTF) is defined as the time from the date of study enrollment to the date of the first observation of disease progression, death from any cause, or early discontinuation of treatment (any reason). For patients who are alive, progression-free, and have not discontinued early at the time of analysis, TTTF will be censored at the date of the last objective progression-free disease assessment.
Measured: First treatment to discontinuation of study drug, progressive disease, or death (up to 31 months)
Phase 2 - Overall Survival
Overall survival is defined as the time from the date of study enrollment to the date of death from any cause. This analysis was not done due to the high number of censored patients.
Measured: baseline to date of death from any cause (up to 31 months)
Phase 2 - Number of Participants With Adverse Events (Toxicity)
A listing of adverse events is located in the Reported Adverse Event module.
Measured: baseline through end of Phase 2 (up to 31 months)
Phase 2 - Progression-Free Survival
Progression-free survival (PFS) is defined as the time from the date of study enrollment to the date of objectively determined PD or death from any cause, whichever comes first. For patients who are still alive at the time of analysis, and who do not have PD, PFS will be censored at the date of the last objective progression-free disease assessment.
Measured: baseline to measured progressive disease (up to 31 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2007 (estimated)
- Study startJul 2005
- Primary completionFeb 2010
- Study completionFeb 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Ovarian CancerStudies of the same condition, open and under way.
- More trials run by Eli Lilly and CompanyThe 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
- Single group
- Masking
- None (open label)
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), Study director, Eli Lilly and Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00489359
- Sponsor's protocol ID
- 9516
- Other IDs
- H3E-MC-JMHH
- Status last verified
- May 2011
- First submitted
- 19 Jun 2007
- Last updated
- 16 Jun 2011
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Bookman MA. 2006. GOG0182-ICON5: 5-arm phase III randomized trial of paclitaxel (P) and carboplatin (C) vs combinations with gemcitabine (G), PEG-lipososomal doxorubicin (D), or topotecan (T) in patients (pts) with advanced-stage epithelial ovarian (EOC) or primary peritoneal (PPC) carcinoma. J Clin Oncol 24 (suppl 18S). Abstract 5002.
Sehouli J, Alvarez AM, Manouchehrpour S, Ghatage P, Szczylik C, Zimmermann A, Bauknecht T, Look KY, Oskay-Oezcelik G. A phase II trial of pemetrexed in combination with carboplatin in patients with recurrent ovarian or primary peritoneal cancer. Gynecol Oncol. 2012 Feb;124(2):205-9. doi: 10.1016/j.ygyno.2011.09.007. Epub 2011 Nov 1.
PubMed 22044606
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 and 2 Clinical Trial of ALIMTA® (Pemetrexed) in Combination With Carboplatin in Patients With Recurrent Ovarian or Primary Peritoneal Cancer
- ClinicalTrials.gov ID
- NCT00489359
- Acronym / sponsor ID
- 9516
- Conditions
- Ovarian Cancer, Primary Peritoneal Cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- Jul 2005
- Primary completion
- Feb 2010 (actual)
- Study completion
- Feb 2010 (actual)
- First posted
- 21 Jun 2007 (estimated)
- Results
- Posted 16 Jun 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine efficacy of the combination therapy of pemetrexed and carboplatin as treatment for patients with platinum-sensitive ovarian cancer. This study also includes patients with primary peritoneal cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pemetrexed/Carboplatin Phase 1 | Experimental | Drug: Pemetrexed - Phase 1, Drug: Carboplatin - Phase 1Pemetrexed was administered intravenously over approximately 10 minutes on Day 1 of a 21-day cycle. Carboplatin was administered intravenously over approximately 30 minutes on Day 1 of a 21-day cycle, beginning approximately 30 minutes after the end of the pemetrexed infusion. |
| Pemetrexed/Carboplatin Phase 2 | Experimental | Drug: Pemetrexed - Phase 2, Drug: Carboplatin - Phase 2Pemetrexed was administered intravenously over approximately 10 minutes on Day 1 of a 21-day cycle. Carboplatin was administered intravenously over approximately 30 minutes on Day 1 of a 21-day cycle, beginning approximately 30 minutes after the end of the pemetrexed infusion. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Diagnosis of ovarian or primary peritoneal cancer confirmed by pathology
- Patients must have recurrent ovarian cancer which is sensitive to platinum therapy
- Prior radiation therapy is allowed
- Measurable disease as defined by the Response Evaluation Criteria In Solid Tumors (RECIST) guidelines, or non-measurable but cancer antigen 125 (CA-125) greater than or equal to 2X upper limit.
Key exclusion criteria (3 listed)
- More than 2 lines of therapy for ovarian or primary peritoneal cancer.
- Pregnant or breast feeding.
- Have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry.
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 |
|---|---|---|
| Pemetrexed - Phase 1Also: LY231514, Alimta500, 600, 700, 800, or 900 milligrams per square meter (mg/m^2), administered intravenously (IV), every 21 days x 6 cycles, dose escalate to Maximum Tolerated Dose (MTD) | Drug | Pemetrexed/Carboplatin Phase 1 |
| Carboplatin - Phase 1area under the concentration time curve (AUC) 5 or 6 mg/mL*min, administered intravenously (IV), every 21 days x 6 cycles, dose escalation to Maximum Tolerated Dose (MTD) | Drug | Pemetrexed/Carboplatin Phase 1 |
| Pemetrexed - Phase 2Also: LY231514, AlimtaDose determined from Phase 1: 500 mg/m^2, administered IV, every 21 days x 6 cycles | Drug | Pemetrexed/Carboplatin Phase 2 |
| Carboplatin - Phase 2Dose determined from Phase 1: AUC 6 mg/mL*min, administered IV, every 21 days x 6 cycles | Drug | Pemetrexed/Carboplatin Phase 2 |
Primary outcome
Phase 1 - Maximum Tolerated Dose (MTD) of Pemetrexed in Combination With Carboplatin
Time frame: First treatment to toxicity (up to 18 months)
MTD was to be determined by increasing doses of pemetrexed up to 900 mg/m^2 and carboplatin Area Under the Concentration-Time Curve (AUC) up to 6 mg/mL*min based on observed pattern of dose limiting toxicity (DLT). See Outcome #3 for DLT. If none of 3 initial participants at a given level experienced a DLT in Cycle 1, enrollment proceeded to the next dose level. If at least 2 participants experienced a DLT in Cycle 1 at a dose level, that dose level was considered the MTD. However, based on results from a different Phase 2 Study (NCT00109096), further dose escalations were not explored.
Phase 2 - Percentage of Participants With Overall Tumor Response (Response Rate)
Time frame: baseline to measured progressive disease (PD) (up to 18 months)
Response is defined as CR (Complete Response) or PR (Partial Response) per Response Evaluation Criteria in Solid Tumor (RECIST criteria). Possible evaluations include: CR: Disappearance of all target lesions. PR: At least a 30% decrease in the size of target lesions. Response rate (%) = (number of patients with CR+PR/number of patients in Phase 2)*100
12 secondary outcomes
Phase 1 - Number of Dose-Limiting Toxicities (DLTs)
Time frame: baseline through end of Phase 1 (up to 18 months)
Phase 1 - Number of Participants With Adverse Events (Toxicity)
Time frame: baseline measured to progressive disease (up to 18 months)
Phase 1 - Recommended Dose of Pemetrexed for Phase 2
Time frame: baseline measured to progressive disease (up to 18 months)
Phase 1 - Recommended Area Under the Curve (AUC) Dose of Carboplatin for Phase 2
Time frame: baseline measured to progressive disease (up to 18 months)
Phase 1 - Number of Participants With Tumor Response
Time frame: baseline measured to progressive disease (up to 18 months)
Phase 2 - Time to Response (TTR)
Time frame: First treatment to response (up to 31 months)
Phase 2 - Duration of Response (DOR)
Time frame: time of response to progressive disease (up to 31 months)
Phase 2 - Time to Disease Progression
Time frame: baseline to measured progressive disease (up to 31 months)
Phase 2 - Time to Treatment Failure
Time frame: First treatment to discontinuation of study drug, progressive disease, or death (up to 31 months)
Phase 2 - Overall Survival
Time frame: baseline to date of death from any cause (up to 31 months)
Phase 2 - Number of Participants With Adverse Events (Toxicity)
Time frame: baseline through end of Phase 2 (up to 31 months)
Phase 2 - Progression-Free Survival
Time frame: baseline to measured progressive disease (up to 31 months)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2011.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- BackgroundBookman MA. 2006. GOG0182-ICON5: 5-arm phase III randomized trial of paclitaxel (P) and carboplatin (C) vs combinations with gemcitabine (G), PEG-lipososomal doxorubicin (D), or topotecan (T) in patients (pts) with advanced-stage epithelial ovarian (EOC) or primary peritoneal (PPC) carcinoma. J Clin Oncol 24 (suppl 18S). Abstract 5002.
- Derived from this study: PubMed 22044606Sehouli J, Alvarez AM, Manouchehrpour S, Ghatage P, Szczylik C, Zimmermann A, Bauknecht T, Look KY, Oskay-Oezcelik G. A phase II trial of pemetrexed in combination with carboplatin in patients with recurrent ovarian or primary peritoneal cancer. Gynecol Oncol. 2012 Feb;124(2):205-9. doi: 10.1016/j.ygyno.2011.09.007. Epub 2011 Nov 1.
- Lilly Clinical Trial RegistryLink 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.
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) study director
Eli Lilly and Company
22 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Pemetrexed - Phase 1, Carboplatin - Phase 1 and Pemetrexed - Phase 2 in people with Ovarian Cancer and Primary Peritoneal Cancer, run by Eli Lilly and Company at 22 sites in 5 countries.
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 4 inclusion and 3 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 16 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 sites in Germany, Argentina, Poland, Canada, Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 Jun 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Phase 1 - Maximum Tolerated Dose (MTD) of Pemetrexed in Combination With Carboplatin (time frame: First treatment to toxicity (up to 18 months)). 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 NCT00489359, which also lists 2 linked publications.
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 16 Jun 2011.