--- title: Bryostatin 1 Plus Paclitaxel in Treating Patients With Locally Advanced or Metastatic Esophageal Cancer or Stomach Cancer nct_id: NCT00005599 overall_status: COMPLETED phase: PHASE2 sponsor: Memorial Sloan Kettering Cancer Center study_type: INTERVENTIONAL primary_condition: Esophageal Cancer countries: United States canonical_url: "https://parkinsonspathways.com/agent/trials/NCT00005599.md" clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT00005599" ct_last_update_post_date: 2013-06-21 last_seen_at: "2026-05-12T07:24:22.585Z" source: ClinicalTrials.gov (mirrored, no enrichment) --- # Bryostatin 1 Plus Paclitaxel in Treating Patients With Locally Advanced or Metastatic Esophageal Cancer or Stomach Cancer **Official Title:** Phase II Trail of Bryostatin-1 and Paclitaxel in Patients With Advanced Esophageal Cancer **NCT ID:** [NCT00005599](https://clinicaltrials.gov/study/NCT00005599) ## Key Facts - **Status:** COMPLETED - **Phase:** PHASE2 - **Study Type:** INTERVENTIONAL - **Lead Sponsor:** Memorial Sloan Kettering Cancer Center - **Collaborators:** National Cancer Institute (NCI) - **Conditions:** Esophageal Cancer, Gastric Cancer - **Start Date:** 2000-02 - **Completion Date:** 2004-08 - **CT.gov Last Update:** 2013-06-21 ## Brief Summary 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. ## Detailed Description 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 - **Minimum age:** 18 Years - **Sex:** ALL - **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 ``` ## Interventions - **bryostatin 1** (DRUG) - **paclitaxel** (DRUG) ## Locations (2) - Memorial Sloan-Kettering Cancer Center, New York, New York, United States - Albert Einstein Clinical Cancer Center, The Bronx, New York, United States ## Recent Field Changes (last 30 days) - `status.overallStatus` — added _(2026-05-12)_ - `status.completionDate` — added _(2026-05-12)_ - `status.lastUpdatePostDate` — added _(2026-05-12)_ - `design.phases` — added _(2026-05-12)_ - `eligibility.criteria` — added _(2026-05-12)_ - `eligibility.minAge` — added _(2026-05-12)_ - `eligibility.sex` — added _(2026-05-12)_ - `armsInterventions.interventions` — added _(2026-05-12)_ - `sponsor.lead` — added _(2026-05-12)_ - `sponsor.collaborators` — added _(2026-05-12)_ - `results.hasResults` — added _(2026-05-12)_ - `locations.memorial sloan-kettering cancer center|new york|new york|united states` — added _(2026-05-12)_ - `locations.albert einstein clinical cancer center|the bronx|new york|united states` — added _(2026-05-12)_ --- *Canonical: https://parkinsonspathways.com/agent/trials/NCT00005599.md* *Source data (authoritative): https://clinicaltrials.gov/study/NCT00005599* *This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*