Bryostatin 1 Plus Paclitaxel in Treating Patients With Locally Advanced or Metastatic Esophageal Cancer or Stomach Cancer

NCT00005599 | Completed Phase 2

• 4 other identifiers: CDR0000067712MSKCC-99094MSKCC-FDR001826NCI-250
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 2

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.

Conditions

Esophageal Cancer; Gastric Cancer

Keywords

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

Interventions

bryostatin 1 DRUG

paclitaxel DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (2)

Memorial Sloan-Kettering Cancer Center

New York, New York, 10021, United States

Location

Albert Einstein Clinical Cancer Center

The Bronx, New York, 10467, United States

Location

Related Publications (1)

• Ku 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 RESULT

MeSH Terms

Conditions

Esophageal Neoplasms; Stomach Neoplasms; Esophageal Squamous Cell Carcinoma; Adenocarcinoma Of Esophagus

Interventions

bryostatin 1; Paclitaxel

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases; Stomach Diseases; Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms, Squamous Cell

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Study Officials

• Gary K. Schwartz, MD

  Memorial Sloan Kettering Cancer Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: May 2, 2000
• First Posted: January 27, 2003
• Study Start: February 1, 2000
• Study Completion: August 1, 2004
• Last Updated: June 21, 2013

Record last verified: 2004-08

Locations

US (2)