Full Text View
Tabular View
No Study Results Posted
Related Studies
Combination Chemotherapy in Treating Patients With Unresectable Locally Advanced or Metastatic Stomach Cancer
This study is ongoing, but not recruiting participants.
First Received: August 3, 2000   Last Updated: July 23, 2008   History of Changes
Sponsor: M.D. Anderson Cancer Center
Collaborator: National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00006081
  Purpose

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of combining bryostatin 1 and paclitaxel in treating patients who have unresectable locally advanced or metastatic stomach cancer.


Condition Intervention Phase
Esophageal Cancer
Gastric Cancer
Drug: paclitaxel
Phase II

Study Type: Interventional
Study Design: Treatment
Official Title: A Phase II Study of Bryostatin-1 (NSC 339555) Plus Paclitaxel in Patients With Metastatic or Unresectable Locally Advanced Adenocarcinoma of the Stomach or Gastroesophageal Junction

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Study Start Date: June 2000
Detailed Description:

OBJECTIVES:

  • Determine the response rate in patients with unresectable locally advanced or metastatic adenocarcinoma of the stomach or gastroesophageal junction treated with bryostatin 1 and paclitaxel.
  • Determine the qualitative and quantitative toxicity and reversibility of toxicity of this regimen in these patients.

OUTLINE: Patients receive paclitaxel IV over 1 hour on days 1, 8, and 15 and bryostatin 1 IV over 1 hour on days 2, 9, and 16. Treatment continues every 4 weeks for at least 2 courses in the absence of disease progression or unacceptable toxicity. Patients with a complete response (CR) receive up to 4 more courses after achieving CR.

Patients are followed until death.

PROJECTED ACCRUAL: A total of 18-35 patients will be accrued for this study.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed unresectable locally advanced or metastatic adenocarcinoma of the stomach or gastroesophageal junction
  • Measurable disease

    • At least 20 mm with conventional techniques OR
    • At least 10 mm with spiral CT scan
    • The following are not considered measurable:

      • Bone lesions
      • Leptomeningeal disease
      • Ascites
      • Pleural/pericardial effusion
      • Inflammatory breast disease
      • Lymphangitis cutis/pulmonis
      • Abdominal masses that are not confirmed or followed by imaging techniques
      • Cystic lesions
  • No bone metastases as sole disease site
  • No brain metastases

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Performance status:

  • Zubrod 0-1
  • Karnofsky 60-100%

Life expectancy:

  • At least 12 weeks

Hematopoietic:

  • Granulocyte count at least 1,500/mm^3
  • Hemoglobin at least 8 g/dL
  • Platelet count at least 100,000/mm^3
  • No bleeding diathesis

Hepatic:

  • Bilirubin no greater than 1.5 mg/dL
  • Transaminases no greater than 2.5 times upper limit of normal

Renal:

  • Creatinine no greater than 1.5 mg/dL
  • Calcium no greater than 12 mg/dL
  • No symptomatic hypercalcemia

Cardiovascular:

  • No New York Heart Association class III or IV heart disease
  • No angina, myocardial infarction, or congestive heart failure in past 6 months

Other:

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No serious concurrent infections, nonmalignant medical illnesses, or psychiatric disorders that may preclude study
  • No other prior malignancy in past 5 years except nonmelanoma skin cancer or carcinoma in situ of the cervix

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • At least 6 months since prior adjuvant immunotherapy
  • No prior immunotherapy outside of the adjuvant setting
  • No concurrent immunotherapy

Chemotherapy:

  • At least 6 months since prior adjuvant chemotherapy
  • No prior chemotherapy outside of the adjuvant setting
  • No other concurrent chemotherapy

Endocrine therapy:

  • Not specified

Radiotherapy:

  • At least 4 weeks since prior radiotherapy
  • No prior radiotherapy to major bone marrow containing areas (pelvis, lumbar spine) or to study lesion
  • No concurrent radiotherapy

Surgery:

  • At least 1 week since prior minor surgery (3 weeks for major surgery) and recovered

Other:

  • No concurrent anticoagulants
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00006081

Locations
United States, Texas
CCOP - M.D. Anderson Research Base
Houston, Texas, United States, 77030-4009
University of Texas - MD Anderson Cancer Center
Houston, Texas, United States, 77030-4009
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Study Chair: Jaffer A. Ajani, MD M.D. Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Study ID Numbers: CDR0000068069, MDA-ID-99203, NCI-T99-0103
Study First Received: August 3, 2000
Last Updated: July 23, 2008
ClinicalTrials.gov Identifier: NCT00006081     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage III gastric cancer
stage IV gastric cancer
stage III esophageal cancer
stage IV esophageal cancer
adenocarcinoma of the stomach
adenocarcinoma of the esophagus

Additional relevant MeSH terms:
Neoplasms by Histologic Type
Digestive System Neoplasms
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Gastrointestinal Diseases
Esophageal Neoplasms
Mitosis Modulators
Antimitotic Agents
Pharmacologic Actions
Carcinoma
Neoplasms
Stomach Diseases
Digestive System Diseases
Neoplasms by Site
Paclitaxel
Therapeutic Uses
Head and Neck Neoplasms
Stomach Neoplasms
Tubulin Modulators
Gastrointestinal Neoplasms
Esophageal Diseases
Adenocarcinoma
Antineoplastic Agents, Phytogenic
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on November 27, 2009