Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| UCLA-HSPC-9703008 | |||
| P-UPHJOHN-6475-96014 | |||
| NCI-G99-1497 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Pharmacia and Upjohn | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Phase II trial to study the effectiveness of irinotecan in treating patients who have esophageal or stomach cancer.
OBJECTIVES: I. Determine the antitumor activity of irinotecan in patients with adenocarcinoma of the esophagus or gastric cardia. II. Evaluate the toxicities of this drug in this patient population.
OUTLINE: This is a multicenter study. Patients receive irinotecan intravenous (IV) over 90 minutes once a week for 4 weeks followed by a 2 week rest period. Treatment continues in the absence of unacceptable toxicity or disease progression. Patients are followed every 3 months until death.
PROJECTED ACCRUAL: A total of 18-32 patients will be accrued for this study.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| irinotecan hydrochloride | Experimental | One course of therapy is comprised of a 4-week treatment period and a two-week rest period. Drug administration will be based on actual calculated body surface area. Starting dose will be 125 mg/m2/day given once per week on four consecutive weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| irinotecan hydrochloride | Drug | One course of therapy is comprised of a 4-week treatment period and a two-week rest period. Drug administration will be based on actual calculated body surface area. Starting dose will be 125 mg/m2/day given once per week on four consecutive weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| To determine the antitumor activity of irinotecan hydrochloride (CPT-11) in patients with unresectable adenocarcinoma of the esophagus and gastric cardia who have failed prior chemotherapy | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate the toxicities of irinotecan hydrochloride (CPT-11) in the patient population | 2 years |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Joel R. Hecht, MD | Jonsson Comprehensive Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Comprehensive Blood and Cancer Center | Bakersfield | California | 93309 | United States | ||
| St Jude Heritage Health Foundation |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
|
| Fullerton |
| California |
| 92835 |
| United States |
| Daniel Freeman Memorial Hospital | Inglewood | California | 90301 | United States |
| UCLA - Antelope Valley Cancer Center | Lancaster | California | 93534 | United States |
| Pacific Shores Medical Group | Long Beach | California | 90813 | United States |
| Jonsson Comprehensive Cancer Center, UCLA | Los Angeles | California | 90095-1781 | United States |
| Community Hospital of the Monterey Peninsula | Monterey | California | 93940 | United States |
| Office of Jerome L. Rubin | Monterey | California | 93940 | United States |
| Office of Eddie Hu, M.D. | Monterey Park | California | 91754 | United States |
| Ventura County Hematology-Oncology Medical Group, Inc. | Oxnard | California | 93030 | United States |
| Wilshire Oncology Medical Center | Pomona | California | 91767 | United States |
| Salinas Valley Memorial Hospital | Salinas | California | 93901 | United States |
| Cancer Center of Santa Barbara | Santa Barbara | California | 93105 | United States |
| Sansum Medical Clinic | Santa Barbara | California | 93105 | United States |
| James L. Poth, M.D., Michael Alexander, M.D., Inc. | Santa Cruz | California | 95065 | United States |
| Marian Medical Center | Santa Maria | California | 93454 | United States |
| Office of Marilou Terpenning | Santa Monica | California | 90404 | United States |
| Office of Robert C. Klein | Santa Monica | California | 90404 | United States |
| Dominican and Watsonville Community Hospital | Soquel | California | 95073 | United States |
| Los Robles Regional Medical Center | Thousand Oaks | California | 91360 | United States |
| Cancer Care Associates Medical Group | Torrance | California | 90505 | United States |
| UCLA Cancer Center - Santa Clarita | Valencia | California | 91355 | United States |
| Oncology Medical Center of North County | Vista | California | 92083 | United States |
| Valley Hematology and Oncology | West Hills | California | 91307 | United States |
| Cancer Care Consultants | Las Vegas | Nevada | 89119 | United States |
| ID | Term |
|---|---|
| D004938 | Esophageal Neoplasms |
| D013274 | Stomach Neoplasms |
| C562730 | Adenocarcinoma Of Esophagus |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D004066 | Digestive System Diseases |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000077146 | Irinotecan |
| ID | Term |
|---|---|
| D002166 | Camptothecin |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided