Clinical trial · Interventional
Bryostatin 1 Plus Paclitaxel in Treating Patients With Locally Advanced or Metastatic Esophageal Cancer or Stomach Cancer
Phase II Trail of Bryostatin-1 and Paclitaxel in Patients With Advanced Esophageal Cancer
NCT00005599CI-TRIAL-00010933completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Esophageal Cancer | Malignant Esophageal Neoplasm | CURATED_EXACT | 0.92 |
| Gastric Cancer | Malignant Gastric Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| bryostatin 1 | Drug | — | UNRESOLVED |
| paclitaxel | Drug | Paclitaxel | ALIAS |
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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 specifiedReferences
Publications (1)
- RESULTKu GY, Ilson DH, Schwartz LH, Capanu M, O'Reilly E, Shah MA, Kelsen DP, Schwartz GK. Phase II trial of sequential paclitaxel and 1 h infusion of bryostatin-1 in patients with advanced esophageal cancer. Cancer Chemother Pharmacol. 2008 Oct;62(5):875-80. doi: 10.1007/s00280-008-0677-y. Epub 2008 Feb 13. PMID 18270704