NCT00087503

Brief Summary

This will be an international, multicenter, uncontrolled, 2-stage, phase II study in adult patients with advanced gastric cancer, reasonable performance status, good organ function, lack of serious concomitant medical conditions. Patients must have progressed or recurred after a fluoropyrimidine-containing regimen at anytime for primary metastatic disease or within 6 months of last dose of adjuvant therapy. Twenty-one evaluable patients will be enrolled in Stage 1. If at least 2 objective tumor responses are observed in the first 21 evaluable patients, the study will be expanded to enroll a total of 41 evaluable patients. Edotecarin will be administered at a starting dose of 13 mg/m2 as an IV infusion over 60 minutes in repeated 3-week cycles treatment.

Trial Health

93
On Track

Trial Health Score

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

Enrollment
28

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Apr 2004

Shorter than P25 for phase_2

Geographic Reach
5 countries

9 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

April 1, 2004

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

July 9, 2004

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 13, 2004

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2005

Completed
Last Updated

April 1, 2008

Status Verified

March 1, 2008

Enrollment Period

1.2 years

First QC Date

July 9, 2004

Last Update Submit

March 27, 2008

Conditions

Stomach Neoplasms

Outcome Measures

Primary Outcomes (1)

  • To assess the antitumor activity of edotecarin by repeating radiographic assessments at 6-week intervals for all patients.

Secondary Outcomes (3)

  • To determine the time of onset and duration of tumor control, and overall survival.

  • In addition, the safety and tolerability profile of edotecarin will be assessed, and plasma pharmacokinetic (PK) profile of edotecarin will be evaluated.

  • Blood samples for PK evaluation will be collected during Cycles 1 and 2 and limited to the patients included in the first stage of the study.

Interventions

EdotecarinDRUG

Eligibility Criteria

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

You may qualify if:

  • Histologically or cytologically confirmed diagnosis of gastric adenocarcinoma or gastroesophageal junction adenocarcinoma (i.e., an adenocarcinoma with \>50% extension in the stomach)
  • Presence of locally advanced or metastatic disease non-amenable to surgery +/- chemo-radiation with curative intent
  • Progression or recurrence after a fluoropyrimidine-containing regimen at any time for primary metastatic disease or within 6 months of last dose of adjuvant therapy
  • Presence of at least 1 measurable (target) lesion. Target lesions are defined as those lesions that can be measured in at least 1 dimension as \>=20mm with conventional techniques or \>=10mm with spiral computerized tomography (CT) scan. Previously irradiated lesions will not be considered as target lesions.
  • Age \>= 18 years
  • ECOG performance status of 0, 1 or 2
  • Baseline tests within the following limits: Absolute neutrophil count (ANC) \>= 1500/mm3 (1.5 x 10(9)/L) Platelets \>= 100,000/mm3 (100 x 10(9)/L) Hemoglobin \>= 9.0 g/dL Serum creatinine \<= 1.5 mg/dl (or \<= 133 mmol/L) Total serum bilirubin \<= 1.5 x upper limits of normal (ULN) regardless of liver involvement secondary to tumor SGOT \<= 2.5 x ULN; \<=5 x ULN if there is liver involvement secondary to tumor Albumin \>=3.0 g/dL Pregnancy test for females of childbearing potential is negative within 7 days of starting treatment
  • Evidence of personally signed and dated informed consent document indicating that the patient (or legally acceptable representative) has been informed of all pertinent aspects of the trial
  • Willingness and ability to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures

You may not qualify if:

  • Prior treatment with another topoisomerase I inhibitor
  • More than 1 prior chemotherapy regimen for advanced disease
  • Prior radiation therapy to \>25% of the bone marrow
  • Any investigational agent received in the 4 weeks before enrollment to this study and/or current enrollment in another therapeutic clinical trial
  • Previous high-dose chemotherapy requiring hematopoietic stem cell rescue
  • Known brain metastases, or spinal cord compression, or carcinomatous meningitis (baseline CT or magnetic resonance imaging (MRI) scan of the brain required only in case of clinical suspicion of central nervous system metastases)
  • Previous (within the last 5 years) or current malignancies at other sites, except for adequately treated basal cell or squamous cell skin cancer or in situ carcinoma of the cervix uteri
  • Active inflammatory bowel disease, partial or complete bowel obstruction or chronic diarrhea
  • Any of the following in the past 6 months: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident or transient ischemic attack, pulmonary embolism, deep vein thrombosis or other significant thromboembolic event
  • Ongoing cardiac dysrhythmias of NCI CTC grade \>=2, atrial fibrillation of any grade
  • Active infection, including known human immunodeficiency virus (HIV) positivity
  • Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study drug administration or may interfere with the interpretation of study results and, in the judgement of the investigator, would make the subject inappropriate for entry into this study
  • Pregnancy or breast-feeding. Female patients must be surgically sterile or be postmenopausal, or must agree to use effective contraception during the period of therapy. Fertile patients who are refusing to use reliable contraceptive methods

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

Pfizer Investigational Site

Brussels, Belgium

Location

Pfizer Investigational Site

Ghent, Belgium

Location

Pfizer Investigational Site

Leuven, Belgium

Location

Pfizer Investigational Site

Lille, France

Location

Pfizer Investigational Site

Barcelona, Spain

Location

Pfizer Investigational Site

Madrid, Spain

Location

Pfizer Investigational Site

Kaohsiung City, Taiwan

Location

Pfizer Investigational Site

Kwei-Shan, Taiwan

Location

Pfizer Investigational Site

Birmingham, United Kingdom

Location

Pfizer Investigational Site

Location

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

edotecarin

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach 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

July 9, 2004

First Posted

July 13, 2004

Study Start

April 1, 2004

Primary Completion

June 1, 2005

Study Completion

June 1, 2005

Last Updated

April 1, 2008

Record last verified: 2008-03

Locations

FR(1)TW(2)BE(3)ES(2)GB(1)