Clinical trial NCT00034502: A Trial of ALIMTA (Pemetrexed) Plus Irinotecan in Patients Who Have Been Previously Treated For Metastatic Colorectal Cancer.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Colorectal Cancer
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2002-04-30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: This is a non-randomized study in patients who have received prior 5-FU therapy for colorectal cancer. The objective of this trial is to establish a maximum tolerated dose of ALIMTA and irinotecan given in combination as well as to assess the safety and efficacy of this combination for patients with locally advanced or metastatic colorectal cancer. ALIMTA and irinotecan will be given every 21 days.


Eligibility criteria: Inclusion Criteria:

* Histologic or cytologic diagnosis of locally or metastatic colorectal cancer
* Prior therapy with 5-FU for metastatic cancer
* Adequate bone marrow, liver and kidney function

Exclusion Criteria:

* Pregnancy
* Breast feeding
* Inability to interrupt aspirin therapy
* Brain metastasis
* Patients who have been treated previously with ALIMTA or irinotecan

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Wichita
country: United States
facility: For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY(1-877-285-4559) or speak with your personal physician.
state: Kansas
city: New York
country: United States
facility: For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY(1-877-285-4559) or speak with your personal physician.
state: New York
city: Pittsburgh
country: United States
facility: For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY(1-877-285-4559) or speak with your personal physician.
state: Pennsylvania
city: Bielefeld
country: Germany
facility: For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY(1-877-285-4559) or speak with your personal physician.
state: Nordrhein-Westfalen
city: Halle
country: Germany
facility: For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY(1-877-285-4559) or speak with your personal physician.
city: Hamburg
country: Germany
facility: For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY(1-877-285-4559) or speak with your personal physician.
city: Homburg/Saar
country: Germany
facility: For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY(1-877-285-4559) or speak with your personal physician.
city: Magdeburg
country: Germany
facility: For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY(1-877-285-4559) or speak with your personal physician.
city: Munchen
country: Germany
facility: For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY(1-877-285-4559) or speak with your personal physician.
Study officials:
References: