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Gastric CancerPhase 2NCT00415168

Pemetrexed Plus Cisplatin as First-Line Treatment in Stage IV or Recurrence of Gastric Cancer

A Phase 2 study testing pemetrexed and cisplatin in people with Gastric Cancer, run by Eli Lilly and Company at 6 sites in Russia.

Completed

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

Official record
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Trial summary

Study H3E-MW- S108 is a multicenter, single arm, open-label Phase 2 study to determine the response rate of pemetrexed plus cisplatin in patients with Stage IV gastric cancer, not amenable to curative surgery, or recurrence after prior surgery, who have had no prior chemotherapy. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Gastric Cancer
What is being tested?
pemetrexed and cisplatin
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
53 participants
Where
6 sitesRussia
Study dates
Dec 2006to Jul 2009
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 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histologically confirmed diagnosis of adenocarcinoma of the gastric. Stage IV disease, not amenable to curative surgery, or disease recurrence after prior surgery.
  • Disease status must be that of measurable disease with presence of at least one measurable lesion as defined by Response Evaluation Criteria in Solid Tumors (RECIST) criteria.
  • In bidimensionally measurable lesions the longest diameter should be selected for measurement.
  • Tumor lesions in areas of prior radiation therapy may be included only if they were clearly progressing.
  • If only a single lesion is present in a patient who had prior therapy for gastric adenocarcinoma, the neoplastic nature of the lesion should be confirmed by cytology and/or histology.
  • Ultrasound and clinical examination are not allowed for assessment of measurable disease.
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  • Elevation of tumor markers, pleural or pericardial effusion, ascites, bone lesions, cystic lesions, or carcinomatous lymphangitis pulmonis/cutis is defined as not being measurable.
  • Performance Status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Scale.
  • Estimated life expectancy of at least 12 weeks.
  • No prior chemotherapy or radiotherapy.
  • Patient compliance and geographic proximity that allow adequate follow-up.
  • Adequate organ function including the following:
  • Bone marrow: absolute neutrophil count 1.5 x 10 to the ninth power/liter (L), platelets 100 x 10 to the ninth power/L, hemoglobin >=9 grams per deciliter (g/dL).
  • Hepatic: bilirubin <=1.5 x upper limit of normal (ULN); alkaline phosphatase, aspartate transaminase and alanine transaminase <=3.0 x ULN.
  • Renal: Calculated creatinine clearance >=45 milliliters (ml)/minute.
  • Men or women, age 18 to 70 years.
  • For women: Must be surgically sterile, post-menopausal, or compliant with a medically approved contraceptive regimen during and for 3 months after the treatment period; must have a negative serum or urine pregnancy test within 7 days before study enrollment and must not be breast-feeding.
  • For men: Must be surgically sterile, or compliant with a contraceptive regimen during and for 3 months after the treatment period.
  • Signed informed consent from patient.

Who cannot join

  • 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.
  • Concurrent administration of any other tumor therapy.
  • Active infection.
  • Serious concomitant disorders that would compromise the safety of the patient or compromise the patient's ability to complete the study, at the discretion of the investigator.
  • Pregnancy.
  • Breast-feeding.
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  • History of significant neurological or mental disorder, including seizures or dementia.
  • Have had a prior malignancy other than gastric cancer, carcinoma in situ of the cervix, or nonmelanoma skin cancer, unless that prior malignancy was diagnosed and definitively treated at least 5 years previously with no subsequent evidence of recurrence.
  • Patients with a history of low grade (Gleason score less than or equal to 6) localized prostate cancer will be eligible even if diagnosed less than 5 years previously.
  • Inability to interrupt aspirin or other nonsteroidal anti-inflammatory drugs 2 days before, the day of, and 2 days after the dose of pemetrexed plus cisplatin.
  • If a patient is taking a nonsteroidal anti-inflammatory drug (NSAID) or salicylate with a long half-life it should not be taken 5 days before, the day of, and 2 days after the dose of pemetrexed plus cisplatin.
  • Clinically significant ascites or pleural effusion that is apparent at clinical examination and cannot be controlled by drainage or other procedures prior to study enrollment. NOTE: Small effusions noted on computed tomography (CT) scan do not exclude the patient from study enrollment.
  • Inability or unwillingness to take folic acid, vitamin B12 supplementation, or dexamethasone.
  • Known or suspected brain metastasis. Patients who have clinical signs or symptoms that are suspicious of brain metastasis must have a pretreatment CT or magnetic resonance imaging (MRI) of the brain. A patient with documented brain metastasis, at the time of consideration for study entry or in the past, will be excluded from entering in the study.

Trial locations and contacts

6 sites in 1 country.

6 sites in 1 country

Russia6 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.

    Barnaul, 656049

  • 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.

    Ivanovo, 153040

  • 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.

    Kazan', 420029

  • 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.

    Moscow, 117997

  • 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.

    Saint Petersburg, 197758

  • 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.

    Stavropol, 355001

Other trials in Russia

About this study

Official title: Phase 2 Study of ALIMTA® (Pemetrexed) Plus Cisplatin as First-Line Treatment of Gastric Cancer

Study H3E-MW- S108 is a multicenter, single arm, open-label Phase 2 study to determine the response rate of pemetrexed plus cisplatin in patients with Stage IV gastric cancer, not amenable to curative surgery, or recurrence after prior surgery, who have had no prior chemotherapy. It was planned to enroll approximately 50 patients who qualified for tumor response population.

Conditions
Gastric Cancer
Being tested
pemetrexed, cisplatin
Medical subject headings
Stomach 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

    700 milligrams/meters squared (mg/m2), intravenous (IV), every 21 days x 6 cycles

  • cisplatinDrug

    75 mg/m2, IV, every 21 days x 6 cycles

Study groups in NCT00415168
Study groupRoleWhat they receive
Pemetrexed + CisplatinExperimentalNot described
Receives: Drug: pemetrexed; Drug: cisplatin

What is being measured

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

  1. Percentage of Participants With Objective Response (Objective Response Rate)

    Tumor responder is defined as participants exhibiting a best overall study response of complete response (CR; disappearance of all target lesions) or partial response (PR; 30% decrease in sum of longest diameter of target lesions). Non-responders are those who did not meet the above criteria.

    Measured: Baseline to time of response up to six or eight 21-day cycles of treatment

Secondary outcomes (6)

  1. Duration of Response

    Measured from the time of first documentation of CR or PR (whichever status is first recorded) until the date of time to disease progression.

    Measured: Time of response to progressive disease up to six or eight 21-day cycles of treatment; maximum duration of study follow-up was 17.4 months

  2. Progression Free Survival (PFS)

    Defined as time from baseline to the date of disease progression or death on study, whichever occurs first. The PFS 1 definition from the United States Food and Drug Administration (FDA) draft guidance on clinical endpoints was used (FDA 2005).

    Measured: Baseline to measured progressive disease or death up to six or eight 21-day cycles of treatment; maximum duration of study follow-up was 17.4 months

  3. Overall Survival

    Defined as the time from baseline to date of death due to any cause. Survival time is censored at the date of last contact for patients who are still alive or lost to follow up.

    Measured: Baseline to date of death from any cause up to six or eight 21-day cycles of treatment; maximum duration of study follow-up was 17.4 months

  4. Number of Participants With Pharmacology Toxicity - Grade 3 or 4 Laboratory Toxicity Possibly Related to Study Therapy

    Common toxicity criteria (CTC) Grade 3 (severe) or 4 (life-threatening or disabling) laboratory toxicity possibly related to study therapy. A grading (severity) scale is provided for each event term. Grades range from 0 (none) to 5 (death).

    Measured: Baseline through six or eight 21-day cycles of treatment, up to 30 days after study drug discontinuation

  5. Number of Participants With Pharmacology Toxicity - Grade 3 or 4 Non-Laboratory Toxicity Possibly Related to Study Therapy

    Common toxicity criteria (CTC) Grade 3 (severe) or 4 (life-threatening or disabling) non-laboratory toxicity possibly related to study therapy. A grading (severity) scale is provided for each event term. Grades range from 0 (none) to 5 (death).

    Measured: Baseline through six or eight 21-day cycles of treatment, up to 30 days after study drug discontinuation

  6. Number of Participants Who Died During the Study

    Measured: During study drug therapy up to six or eight 21-day cycles or treatment; maximum duration of study follow-up was 17.4 months

Timeline

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

  1. First posted22 Dec 2006 (estimated)
  2. Study startDec 2006
  3. Primary completionJul 2009
  4. Study completionJul 2009

Resources

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
53 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00415168
Sponsor's protocol ID
10874
Other IDs
H3E-MW-S108
Status last verified
Aug 2010
First submitted
20 Dec 2006
Last updated
17 Aug 2010
Data monitoring committee
No

Publications

  • United States Food and Drug Administration (US-FDA). 2005. Guidance for Industry: Clinical Trial Endpoints for the Approval of Cancer Drugs and Biologics (Draft Guidance). Available at: http://www.fda.gov/cder/guidance/6592dft.htm, accessed 01 November 2005. Currently available at: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM071590.pdf, accessed 22 June 2010.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing pemetrexed and cisplatin in people with Gastric Cancer, run by Eli Lilly and Company at 6 sites in Russia.

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 19 inclusion and 14 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 17 Aug 2010. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in Russia. 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 10 Aug 2010). 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?

Percentage of Participants With Objective Response (Objective Response Rate) (time frame: Baseline to time of response up to six or eight 21-day cycles of treatment). 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 NCT00415168, 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 17 Aug 2010.

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