NCT00078468

Brief Summary

To determine the response rate in patients with metastatic colorectal cancer who failed treatment with a 5-Fluorouracil/Leucovorin regimen and up to one other chemotherapeutic regimen (not including adjuvant chemotherapy).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
56

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Dec 2003

Shorter than P25 for phase_2

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2003

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

February 27, 2004

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 2, 2004

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2004

Completed
Last Updated

November 9, 2006

Status Verified

August 1, 2006

First QC Date

February 27, 2004

Last Update Submit

November 8, 2006

Conditions

Colorectal Neoplasms

Outcome Measures

Primary Outcomes (1)

  • To determine the overall objective response rate (complete and partial responses) of AG-2037 in patients with metastatic colorectal cancer who failed treatment with 5FU/LV regimen and up to one other chemotherapeutic regimen.

Secondary Outcomes (6)

  • To estimate time to progression (TTP).

  • To evaluate the overall survival (1-year) of patients treated with AG-2037.

  • To assess changes in patient reported outcomes using health-related quality of life questionnaires.

  • To evaluate the safety of AG-2037.

  • To evalutate the PK and PD of AG-2037.

  • +1 more secondary outcomes

Interventions

PELITREXOL/AG-2037DRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Histologically or cytologically confirmed metastatic adenocarcinoma of the colon or rectum
  • Stage IV or recurrent disease
  • Measurable disease
  • Disease progression or recurrence during or after completion of prior first-line chemotherapy with fluorouracil and leucovorin calcium (5-FU/LV)
  • Prior irinotecan or oxaliplatin as part of the 5-FU/LV regimen or as subsequent therapy allowed
  • Only 2 prior regimens for metastatic disease allowed
  • One additional regimen as adjuvant therapy allowed provided patient remained disease-free for \> 6 months after completion of therapy\*
  • Newer, targeted investigational agents (e.g., cetuximab or bevacizumab) are not
  • counted as a chemotherapeutic regimen unless used in combination with a cytotoxic regimen NOTE: \*If evidence of failure occurred within \< 6 months after completion of adjuvant therapy, patients may have received only 1 additional regimen for metastatic disease
  • No active brain metastases (requiring treatment or progressing)

You may not qualify if:

  • History of blood transfusion within 14 days
  • Need of concurrent Administration of allopurinol
  • History of Radiotherapy or Chemotherapy within 4 weeks
  • Any psychological or sociological condition, addidtive disorder or family problems that might preclude compliance with the protocol
  • Any unstable or severe intercurrent medical condition that in the opinion of th einvestigator might interfere with achievement of study objectives
  • Receipt of an investigational agent within 28 days prior to first day of dosing with AG-2037
  • Pregnant or breast feeding
  • Previous treatment with GARFT inhibitors
  • History of a malignancy (other than colorectal cancer) excpet those treated with curative intent for skin cancer (other than melanoma) or in situ breast or cervical cancer or those treated with curative intent for any other cancer with no evidence of disease for 5 years
  • Active brain metastases (requiring treatment or progression)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Pfizer Investigational Site

Poway, California, 92064, United States

Location

Pfizer Investigational Site

Washington D.C., District of Columbia, 20007, United States

Location

Pfizer Investigational Site

Tampa, Florida, 33612, United States

Location

Pfizer Investigational Site

New York, New York, 10021, United States

Location

Related Links

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

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

February 27, 2004

First Posted

March 2, 2004

Study Start

December 1, 2003

Study Completion

September 1, 2004

Last Updated

November 9, 2006

Record last verified: 2006-08

Locations

US(4)