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Completed

NCT Number: NCT00320515

Study of Pemetrexed Plus Cisplatin in Advanced Gastric Cancer

This is a multicenter, single arm, open-label Phase 1/2 study of pemetrexed plus cisplatin for patients with unresectable, advanced gastric cancer who had no prior palliative chemotherapy. Phase 1 was designed to determine the optimal dose of pemetrexed for its phase 2, which has been completed and now a total of 60 qualified patients will be enrolled in the phase 2 of this study. The treating physician will determined the maximum number of cycles of pemetrexed plus cisplatin that a patient may receive in this study.

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Key information

Conditions

Neoplasm, Gastric Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Neoplasms Neoplasms by Site Stomach Diseases Stomach Neoplasms

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary 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., Buenos Aires, Argentina

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Histological proven diagnosis of adenocarcinoma of the stomach
  • Stage IV disease not amenable to curative surgery.
  • Disease status must be that of measurable disease as defined by Response Evaluation Criteria In Solid Tumors (RECIST) criteria.
  • Performance status of 0 or 1 on Eastern Cooperative Oncology Group (ECOG) scale.
  • Adequate organ functions

Exclusion criteria

  • Prior palliative chemotherapy for advanced gastric cancer.
  • Pregnancy and breast feeding.
  • Known or suspected brain metastasis and secondary primary malignancy
  • Inability to interrupt aspirin, or other non-steroidal anti-inflammatory agents for a 5-day period.
  • Inability or unwillingness to take folic acid or vitamin B12 supplementation.
  • Concurrent administration of any other tumor therapy.

Treatment and study plan

Pemetrexed

Drug

Phase 1 - dose escalating: 600 mg/m2 level 1, 700 mg/m2 level 2, 800 mg/m2 level 3, 900 mg/m2 level 4, intravenous (IV), every 21 days, until disease progression

Phase 2 - 700 mg/m2, intravenous (IV), every 21 days, until disease progression

Other names: LY231514, Alimta

Cisplatin

Drug

75 mg/m2, intravenous (IV), every 21 days, until disease progression

Primary outcomes

  1. Objective Best Tumor Response

    Time frame: baseline to measured progressive disease (Tumor assessments were performed every 2 cycles during therapy and 6-8 weeks during post-therapy until disease progression, or up to 12 months after enrollment)

    Response using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. Complete Response=disappearance of all target lesions; Partial Response=30% decrease in sum of longest diameter of target lesions; Progressive Disease=20% increase in sum of longest diameter of target lesions; Stable Disease=small changes that do not meet above criteria.

Secondary outcomes

  1. Duration of Response

    Time frame: time of response to progressive disease or death (Tumor assessments were performed every 2 cycles during therapy and 6-8 weeks during post-therapy until disease progression, or up to 12 months after enrollment)

    The duration of a complete response (CR) or partial response (PR) was defined as the time from first objective status assessment of CR or PR to the first time of progression or death as a result of any cause.

  2. Progression Free Survival

    Time frame: baseline to measured progressive disease or death (Tumor assessments were performed every 2 cycles during therapy and 6-8 weeks during post-therapy until disease progression, or up to 12 months after enrollment)

    The period from study entry until disease progression or death on study, whichever occurred first.

  3. Overall Survival

    Time frame: baseline to date of death from any cause (Survival follow-up were performed every 2 cycles during therapy and approximately every 3 months during post-therapy until death or up to 12 months after enrollment)

    Overall survival is the duration from enrollment to death. For patients who are alive, overall survival is censored at the last contact.

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

Phase 1/2 Study of Pemetrexed Plus Cisplatin in Unresectable, Advanced Gastric Carcinoma.

Important dates

Study start
2004
Primary completion
2008
Study completion
2008
First posted
May 3, 2006
Registry last updated
Sep 28, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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