Study of Pemetrexed Plus Cisplatin in Advanced Gastric Cancer - Full Text View

Purpose

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.

Condition	Intervention	Phase
Neoplasm, Gastric	Drug: pemetrexed Drug: cisplatin	Phase I 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 1/2 Study of Pemetrexed Plus Cisplatin in Unresectable, Advanced Gastric Carcinoma.

Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:

Phase 1 - determine the dose of pemetrexed recommended for Phase 2 [ Time Frame: every cycle ] [ Designated as safety issue: Yes ]
Phase 2 - evaluate the objective response rate of pemetrexed-cisplatin in this patient population. [ Time Frame: baseline to measured progressive disease ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Phase 1 - evaluate the dose-limiting toxicity of pemetrexed-cisplatin [ Time Frame: every cycle ] [ Designated as safety issue: Yes ]
Phase 2 - duration of response [ Time Frame: time of response to progressive disease ] [ Designated as safety issue: No ]
Phase 2 - progression free survival [ Time Frame: baseline to measured progressive disease ] [ Designated as safety issue: No ]
Phase 2 - overall survival [ Time Frame: baseline to date of death from any cause ] [ Designated as safety issue: Yes ]
Phase 1 and 2 - pharmacology toxicities [ Time Frame: every cycle ] [ Designated as safety issue: Yes ]

Enrollment:	91
Study Start Date:	March 2004
Study Completion Date:	July 2008
Primary Completion Date:	July 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Experimental	Drug: pemetrexed Phase 1 - dose escalating: 600 mg/m2 level 1, 700 mg/m2 level 2, 800 mg/m2 level 3, 900 mg/m2 level 4, IV, q 21 days, until disease progression Phase 2 - 700 mg/m2, IV, q 21 days, until disease progression Drug: cisplatin 75 mg/m2, IV, q 21 days, until disease progression

Eligibility

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

Criteria

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 RECIST criteria.
Performance status of 0 or 1 on 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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00320515

Locations


Argentina
	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, 1264
	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.
	Tucumain, Argentina, 4000

Korea, Republic of
	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.
	Seoul, Korea, Republic of, 136-705

Mexico
	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.
	Ciudad Obregon, Mexico, 85100
	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.
	Guadalajara, Mexico, 44280

Taiwan
	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.
	Tainan, Taiwan, 704
	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.
	Taipei, Taiwan, 112
	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.
	Tao-Yuan, Taiwan, 333

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 from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST)	Eli Lilly and Company

More Information

Lilly Clinical Trial Registry This link exits the ClinicalTrials.gov site

Responsible Party:	Eli Lilly ( Chief Medical Officer )
Study ID Numbers:	7461, H3E-AA-S038
First Received:	April 28, 2006
Last Updated:	July 23, 2008
ClinicalTrials.gov Identifier:	NCT00320515
Health Authority:	Taiwan: Department of Health; Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica; South Korea: Korea Food and Drug Administration (KFDA); Mexico: Federal Commission for Protection Against Health Risks

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

Carcinoma

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 November 06, 2008

Sponsored by:	Eli Lilly and Company
Information provided by:	Eli Lilly and Company
ClinicalTrials.gov Identifier:	NCT00320515