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Pemetrexed Plus Cisplatin as First-Line Treatment in Stage IV or Recurrence of Gastric Cancer
This study is ongoing, but not recruiting participants.
Sponsored by: Eli Lilly and Company
Information provided by: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT00415168
  Purpose

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 is planned to enroll approximately 50 patients who qualify for tumor response population.


Condition Intervention Phase
Gastric Cancer
Drug: pemetrexed
Drug: cisplatin
Phase II

MedlinePlus related topics: Cancer Stomach Cancer
Drug Information available for: Cisplatin Pemetrexed disodium Pemetrexed
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title: Phase 2 Study of ALIMTA® (Pemetrexed) Plus Cisplatin as First-Line Treatment of Gastric Cancer

Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • Objective response rate [ Time Frame: baseline to time of response ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Duration of response [ Time Frame: time of response to progressive disease ] [ Designated as safety issue: No ]
  • Progression Free Survival [ Time Frame: baseline to measured progressive disease ] [ Designated as safety issue: No ]
  • Overall Survival [ Time Frame: baseline to date of death from any cause ] [ Designated as safety issue: Yes ]
  • Pharmacology toxicity [ Time Frame: every cycle ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 50
Study Start Date: December 2006
Estimated Study Completion Date: May 2010
Estimated Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
A: Experimental Drug: pemetrexed
700 mg/m2, IV, q 21 days x 6 cycles
Drug: cisplatin
75 mg/m2, IV, q 21 days x 6 cycles

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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 RECIST criteria.
  • 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.
  • Performance Status of 0 or 1 on the 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 1.5 109/L, platelets 100 109/L, hemoglobin 9 g/dL.
  • Hepatic: bilirubin 1.5 x ULN; alkaline phosphatase, aspartate transaminase and alanine transaminase 3.0 x ULN.
  • Renal: Calculated creatinine clearance 45 ml/min.
  • 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.

Exclusion Criteria:

  • 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.
  • 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 an 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 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 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00415168

Locations
Russian Federation
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, Russian Federation, 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, Russian Federation, 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, Russian Federation, 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.
Stavropol, Russian Federation, 355001
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, Russian Federation, 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.
Moscow, Russian Federation, 117997
Sponsors and Collaborators
Eli Lilly and Company
Investigators
Study Director: 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) Eli Lilly and Company
  More Information

Responsible Party: Eli Lilly ( Chief Medical Officer )
Study ID Numbers: 10874, H3E-MW-S108
Study First Received: December 20, 2006
Last Updated: January 14, 2009
ClinicalTrials.gov Identifier: NCT00415168  
Health Authority: Russia: Ethics Committee;   Russia: Ministry of Health and Social Development of the Russian Federation;   Russia: Pharmacological Committee, Ministry of Health

Study placed in the following topic categories:
Folic Acid
Pemetrexed
Stomach Diseases
Digestive System Diseases
Digestive System Neoplasms
Cisplatin
Gastrointestinal Diseases
Stomach Neoplasms
Gastrointestinal Neoplasms
Stomach cancer
Recurrence

Additional relevant MeSH terms:
Antimetabolites
Neoplasms
Antimetabolites, Antineoplastic
Neoplasms by Site
Molecular Mechanisms of Pharmacological Action
Radiation-Sensitizing Agents
Antineoplastic Agents
Therapeutic Uses
Physiological Effects of Drugs
Enzyme Inhibitors
Folic Acid Antagonists
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009