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Open Multicenter Phase II Study in Second-Line Metastatic Colorectal Cancer Patients: Combination of ALIMTA and Irinotecan Administered Every Two-Weeks


Phase 2
18 Years
N/A
Not Enrolling
Both
Metastatic Colorectal Cancer

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Trial Information

Open Multicenter Phase II Study in Second-Line Metastatic Colorectal Cancer Patients: Combination of ALIMTA and Irinotecan Administered Every Two-Weeks


Inclusion Criteria:



- Diagnosis of metastatic colorectal adenocarcinoma that is not amenable to curative
therapy.

- Patient must have at least one unidimensionally measurable lesion.

- Prior radiation therapy to less than 25% of bone marrow. Radiation must be completed
at least 4 weeks prior to study enrollment.

- Performance status 0 to 2

- Patient must have received 1 prior course of chemotherapy (Folfox regimen) for
metastatic disease

Exclusion Criteria:

- Treatment with any drug within the last 30 days that has not received regulatory
approval.

- Serious systemic disorder (cardiac or pulmonary disease, active infection)

- Documented brain metastases not amenable to surgery or unstable after radiation

- Inability or unwillingness to take folic acid or Vitamin B12 supplementation.

- Presence of fluid retention that can not be controlled by drainage.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Best Overall Tumor Response

Outcome Description:

Best response recorded from the start of treatment until disease progression/recurrence using Response Evaluation Criteria In Solid Tumors (RECIST) criteria that defines when participants improve ("respond"), stay the same ("stable"), or worsen ("progression") during treatment. Complete response (CR) = disappearance of all target lesions. Partial response (PR) = 30% decrease in the sum of the longest diameter of target lesions. Progressive disease (PD) = 20% increase in the sum of the longest diameter of target lesions. Stable disease (SD) = small changes that do not meet above criteria.

Outcome Time Frame:

baseline to measured progressive disease (up to 2 years follow-up)

Safety Issue:

No

Principal Investigator

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

Investigator Role:

Study Director

Investigator Affiliation:

Eli Lilly and Company

Authority:

France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Study ID:

8673

NCT ID:

NCT00191984

Start Date:

June 2004

Completion Date:

May 2008

Related Keywords:

  • Metastatic Colorectal Cancer
  • Colorectal Neoplasms

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