Rectal NeoplasmsPhase 2NCT00330915

A Study of Pemetrexed and Folic Acid Given Before Surgery (Neoadjuvant Treatment) to Patients With Rectal Cancer.

A Phase 2 study testing pemetrexed in people with Rectal Neoplasms, run by Eli Lilly and Company at 1 site in Sweden.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

The purpose of this study is to help answer the following research questions: If the study drug Pemetrexed can help patients with rectal cancer; If molecular biological parameters are correlated respectively changing due to cytotoxic treatment with Pemetrexed; To evaluate adverse events Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Rectal Neoplasms
What is being tested?: pemetrexed
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 37 participants
Where: 1 siteSweden
Study dates: Jun 2006to Jun 2008
Phase: Phase 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
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

no prior therapy for rectal cancer
pathological/ cytological diagnosis of adenocarcinoma of the rectum. Patients must have operable rectal cancer that is amenable to surgery.
adequate organ function
Eastern Cooperative Oncology Group (ECOG) Performance status 0 or 1
signed informed consent
at least 18 years of age
surgically sterile, postmenopausal (women) or compliant with a medically approved contraceptive regimen during and for 6 months after the treatment.

Who cannot join

concurrent administration of any other anti-tumor therapy
treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry
serious concomitant systemic disorders
previously completed or withdrawn from this study
pregnant or breast-feeding
second primary malignancy

Show all 10Show fewer

history of significant neurological or mental disorder, including seizures or dementia
inability to interrupt aspirin or other nonsteroidal anto-inflammatory drugs (NSAIDs)
presence of clinically relevant third space fluid collections that cannot be controlled by drainage or other procedure prior to the study entry
inability or unwillingness to take folic acid, vitamin B12 or dexamethasone

Trial locations and contacts

1 site in 1 country.

Sweden1 site

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.
Gothenburg, 41685

Other trials in Sweden

About this study

Official title: A Feasibility Study of Pemetrexed Single Agent and Folic Acid Given as Neoadjuvant Treatment in Patients With Resectable Rectal Cancer

The purpose of this study is to help answer the following research questions:

If the study drug Pemetrexed can help patients with rectal cancer; If molecular biological parameters are correlated respectively changing due to cytotoxic treatment with Pemetrexed; To evaluate adverse events

Conditions: Rectal Neoplasms
Being tested: pemetrexed
Medical subject headings: Rectal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

pemetrexedDrug
Also called LY231514, Alimta
500 mg/m2, intravenous (IV), every 21 days x 3 cycles

Study groups in NCT00330915
Study group	Role	What they receive
A	Experimental	Not described Receives: Drug: pemetrexed

What is being measured

The primary outcome is the main question the study is designed to answer.

Feasibility of Pemetrexed Prior to Surgery
Feasibility was defined as the ability to receive the total planned dose of Pemetrexed administered over a period of no more than 9 weeks permitting scheduling conflict. A ±5 percent variance in the calculated total dose was allowed.
Measured: 3 cycles (21-day cycles)

Secondary outcomes (3)

Pathological Complete Response (pCR)
Pathological complete response was defined as the absence of any tumor cells.
Measured: surgery following 3 cycles (21-day cycles) of chemotherapy
Number of Participants With Complete Tumor Resection
Measured: surgery following 3 cycles (21-day cycles) of chemotherapy
Number of Participants Receiving Sphincter Saving Surgery
Measured: surgery following 3 cycles (21-day cycles) of chemotherapy

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jun 2006Jun 2008

First posted29 May 2006 (estimated)
Study startJun 2006
Primary completionJun 2008
Study completionJun 2008

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.
Other trials for Rectal NeoplasmsStudies 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 2
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 37 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00330915
Sponsor's protocol ID: 9732
Other IDs: H3E-MC-S077
Status last verified: Jun 2009
First submitted: 26 May 2006
Last updated: 21 Jul 2009
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Rectal Neoplasms trials

Study at a glance

From the registry record, last updated by the sponsor on 21 Jul 2009. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Feasibility Study of Pemetrexed Single Agent and Folic Acid Given as Neoadjuvant Treatment in Patients With Resectable Rectal Cancer
ClinicalTrials.gov ID: NCT00330915
Acronym / sponsor ID: 9732
Conditions: Rectal Neoplasms
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 37 participants (actual)
Lead sponsor: Eli Lilly and CompanyIndustry (pharma, biotech, devices)
Study start: Jun 2006
Primary completion: Jun 2008 (actual)
Study completion: Jun 2008 (actual)
First posted: 29 May 2006 (estimated)
Results: Posted 21 Jul 2009

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 help answer the following research questions:

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
A	Experimental	Drug: pemetrexed

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

no prior therapy for rectal cancer
pathological/ cytological diagnosis of adenocarcinoma of the rectum. Patients must have operable rectal cancer that is amenable to surgery.
adequate organ function
Eastern Cooperative Oncology Group (ECOG) Performance status 0 or 1
signed informed consent

Key exclusion criteria (10 listed)

concurrent administration of any other anti-tumor therapy
treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry
serious concomitant systemic disorders
previously completed or withdrawn from this study
pregnant or breast-feeding

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
pemetrexedAlso: LY231514, Alimta500 mg/m2, intravenous (IV), every 21 days x 3 cycles	Drug	A

Primary outcome

Feasibility of Pemetrexed Prior to Surgery
Time frame: 3 cycles (21-day cycles)
Feasibility was defined as the ability to receive the total planned dose of Pemetrexed administered over a period of no more than 9 weeks permitting scheduling conflict. A ±5 percent variance in the calculated total dose was allowed.

3 secondary outcomes

Pathological Complete Response (pCR)
Time frame: surgery following 3 cycles (21-day cycles) of chemotherapy
Number of Participants With Complete Tumor Resection
Time frame: surgery following 3 cycles (21-day cycles) of chemotherapy
Number of Participants Receiving Sphincter Saving Surgery
Time frame: surgery following 3 cycles (21-day cycles) of chemotherapy

Results and safety

Results posted to the registry on 21 Jul 2009, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Pemetrexed	37	37

Primary outcome: Feasibility of Pemetrexed Prior to Surgery

Time frame: 3 cycles (21-day cycles). Number. Unit: participants

Measure	Pemetrexed n = 37
Feasibility - Yes	33
Feasibility - No	4

Population analysed: Number of participants enrolled.

3 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Pemetrexed	17 of ?	37 of ?	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2009.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Lilly Clinical Trial RegistryLink provided by the sponsor.

Related trials for Rectal Neoplasms

Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingObservational study
Pre- and On-treatment Multi-omics Profiling of Locally Advanced Rectal Cancer
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Enrolling by invitationObservational study
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RecruitingPhase 2
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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 - 5PM Eastern time (UTC/ GMT - 5 hours, EST) study director

Eli Lilly and Company

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing pemetrexed in people with Rectal Neoplasms, run by Eli Lilly and Company at 1 site in Sweden.

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 7 inclusion and 10 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 21 Jul 2009. 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 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 phase mean?

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 21 Jul 2009). 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?

Feasibility of Pemetrexed Prior to Surgery (time frame: 3 cycles (21-day cycles)). 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 NCT00330915.

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 21 Jul 2009.