Know Cancer

forgot password

A Phase II Efficacy And Safety Study Intravenous Edotecarin In Patients With Advanced Gastric Cancer That Has Progressed Or Recurred After Prior Fluropyrimidine-Based Chemotherapy

Phase 2
18 Years
Not Enrolling
Stomach Neoplasms

Thank you

Trial Information

A Phase II Efficacy And Safety Study Intravenous Edotecarin In Patients With Advanced Gastric Cancer That Has Progressed Or Recurred After Prior Fluropyrimidine-Based Chemotherapy

Inclusion Criteria:

- 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.

- All previous therapies must have been discontinued at least 4 weeks before study
entry, and all acute toxic effects (excluding alopecia or neurotoxicity) of any prior
therapy must have resolved to NCI CTC (Version 2.0) Grade <=1 (please see inclusion
criteria #8 below for exceptions)

- 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

Exclusion Criteria:

- 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

- 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

Type of Study:


Study Design:

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

Outcome Measure:

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

Principal Investigator

Pfizer Call Center

Investigator Role:

Study Director

Investigator Affiliation:



United States: Food and Drug Administration

Study ID:




Start Date:

April 2004

Completion Date:

June 2005

Related Keywords:

  • Stomach Neoplasms
  • Neoplasms
  • Stomach Neoplasms