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

NCT00415168 | Completed Phase 2 Results

• 2 other identifiers: 10874H3E-MW-S108
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 6

Brief 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. It was planned to enroll approximately 50 patients who qualified for tumor response population.

Conditions

Gastric Cancer

Outcome Measures

Primary Outcomes (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.

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

Secondary Outcomes (6)

• Duration of Response

  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

• Progression Free Survival (PFS)

  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

• Overall Survival

  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

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

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

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

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

Study Arms (1)

Pemetrexed + Cisplatin

EXPERIMENTAL

Drug: pemetrexed; Drug: cisplatin

Interventions

pemetrexed DRUG

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

Also known as: LY231514, Alimta

Pemetrexed + Cisplatin

cisplatin DRUG

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

Pemetrexed + Cisplatin

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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 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.

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (6)

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, Russia

Location

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, Russia

Location

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, Russia

Location

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, Russia

Location

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, Russia

Location

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, Russia

Location

Related Publications (1)

• 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.

  BACKGROUND

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

Pemetrexed; Cisplatin

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Intervention Hierarchy (Ancestors)

Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Dicarboxylic; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Results Point of Contact

• Title: Chief Medical Officer
• Organization: Eli Lilly and Company

800-545-5979

Study Officials

• 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

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: December 20, 2006
• First Posted: December 22, 2006
• Study Start: December 1, 2006
• Primary Completion: July 1, 2009
• Study Completion: July 1, 2009
• Last Updated: August 17, 2010
• Results First Posted: August 10, 2010

Record last verified: 2010-08

Locations

RU (6)