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Intravenous Edotecarin in Patients With Advanced Gastric Cancer That Has Progressed or Recurred After Chemotherapy

Last updated on December 17, 2017

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Bruxelles, , Belgium
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Stomach Neoplasms
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18+ years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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 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 upper limits of normal (ULN) regardless of liver involvement secondary to tumor SGOT
=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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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

NCT00087503
Pfizer
Completed
Intravenous Edotecarin in Patients With Advanced Gastric Cancer That Has Progressed or Recurred After Chemotherapy

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Intravenous Edotecarin in Patients With Advanced Gastric Cancer That Has Progressed or Recurred After Chemotherapy
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
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.
Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Stomach Neoplasms
Drug: Edotecarin
Not Provided
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
28
June 2005
June 2005   (Final data collection date for primary outcome measure)

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 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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Belgium,   France,   Spain,   Taiwan,   United Kingdom
 
 
NCT00087503
EDOAGA-6736-001
A5921008
Not Provided
Not Provided
Not Provided
Not Provided
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
March 2008

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]



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