Bryostatin 1 Plus Paclitaxel in Treating Patients With Locally Advanced or Metastatic Esophageal Cancer or Stomach Cancer
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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 bryostatin 1 and paclitaxel in treating patients who have locally advanced or metastatic esophageal cancer or stomach cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Esophageal Cancer Gastric Cancer |
Drug: bryostatin 1 Drug: paclitaxel |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Phase II Trail of Bryostatin-1 and Paclitaxel in Patients With Advanced Esophageal Cancer |
| Study Start Date: | February 2000 |
OBJECTIVES:
- Determine the complete and partial response rates in patients with unresectable or metastatic esophageal cancer or carcinoma of the gastroesophageal junction treated with sequential paclitaxel and bryostatin 1.
- Determine the toxicity of this regimen in this patient population.
- Determine the survival of patients after treatment with this regimen.
- Determine the quality of life of patients treated with this regimen.
- Examine pre- and post-treatment tissue biopsies for markers of apoptosis in selected patients.
OUTLINE: This is a multicenter study.
Patients receive paclitaxel IV over 1 hour on day 1 and bryostatin 1 IV over 24 hours on day 2 weekly for 2 weeks. Courses repeat every 28 days in the absence of unacceptable toxicity or disease progression.
Quality of life is assessed at baseline, after courses 1 and 2, and then after every 2 courses thereafter.
PROJECTED ACCRUAL: A total of 19-33 patients will be accrued for this study within 1-2 years.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed squamous cell carcinoma or adenocarcinoma of the esophagus or carcinoma of the gastroesophageal (GE) junction
- If tumor extends below GE junction into the proximal stomach, 50% of the tumor must involve the esophagus or GE junction
- No gastric cancer with only a minor involvement of GE junction or distal esophagus
- Locally advanced and considered surgically unresectable or metastatic
Measurable disease
- Accurately measured in at least 1 dimension as at least 20 mm with conventional techniques or at least 10 mm with spiral CT scan
No truly nonmeasurable lesions only:
- Bone lesions
- Leptomeningeal disease
- Ascites
- Pleural/pericardial effusions
- Inflammatory breast disease
- Lymphangitis cutis/pulmonis
- Abdominal masses not confirmed and followed by imaging techniques
- Cystic lesions
- No brain metastases
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Performance status:
- Karnofsky 70-100%
Life expectancy:
- Not specified
Hematopoietic:
- Granulocyte count at least 1,500/mm^3
- Platelet count at least 150,000/mm^3
Hepatic:
- Bilirubin no greater than 1.5 mg/dL
Renal:
- Creatinine no greater than 1.5 mg/dL
Cardiovascular:
- No history of active angina
- No myocardial infarction within the past 6 months
- No history of significant ventricular arrhythmia requiring medication with antiarrhythmics
- Well-controlled atrial fibrillation on standard management allowed
Pulmonary:
- DLCO at least 60%
Other:
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for 2 months after study participation
- No preexisting neurotoxicity of grade 3 or greater
- No serious concurrent infection or nonmalignant medical illness that is uncontrolled or whose control may be jeopardized by complications of study therapy
- No concurrent psychiatric disorders that would preclude study compliance
No other active malignancy within the past 5 years except:
- Nonmelanoma skin cancer
- Carcinoma in situ of the cervix
- History of T1a or b prostate cancer (detected incidentally at transurethral resection of prostate [TURP] and comprising less than 5% of resected tissue) provided prostate-specific antigen remained normal since TURP removal
- HIV negative
- No other concurrent medical condition that would preclude study therapy
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- No concurrent immunotherapy
Chemotherapy:
- Recovered from prior chemotherapy
- No more than 1 prior neoadjuvant or adjuvant regimen for esophageal cancer
- No prior taxanes for esophageal cancer
- No prior bryostatin 1 for esophageal cancer
- No other concurrent chemotherapy
Endocrine therapy:
- Not specified
Radiotherapy:
- Prior radiotherapy allowed provided recent evidence of disease progression if indicator lesion is within prior radiation field
- Recovered from prior radiotherapy
- No concurrent radiotherapy
Surgery:
- Not specified
Contacts and Locations| United States, New York | |
| Albert Einstein Clinical Cancer Center | |
| Bronx, New York, United States, 10467 | |
| Memorial Sloan-Kettering Cancer Center | |
| New York, New York, United States, 10021 | |
| Study Chair: | Gary K. Schwartz, MD | Memorial Sloan-Kettering Cancer Center |
More Information
Additional Information:
Publications:
| ClinicalTrials.gov Identifier: | NCT00005599 History of Changes |
| Other Study ID Numbers: | CDR0000067712, MSKCC-99094, MSKCC-FDR001826, NCI-250 |
| Study First Received: | May 2, 2000 |
| Last Updated: | April 18, 2009 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Cancer Institute (NCI):
|
stage III gastric cancer stage IV gastric cancer recurrent gastric cancer stage III esophageal cancer |
stage IV esophageal cancer recurrent esophageal cancer squamous cell carcinoma of the esophagus adenocarcinoma of the esophagus |
Additional relevant MeSH terms:
|
Esophageal Diseases Esophageal Neoplasms Stomach Neoplasms Gastrointestinal Diseases Digestive System Diseases Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Head and Neck Neoplasms Stomach Diseases Bryostatin 1 |
Paclitaxel Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Adjuvants, Immunologic Immunologic Factors Physiological Effects of Drugs Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action Antineoplastic Agents, Phytogenic |
ClinicalTrials.gov processed this record on May 21, 2013