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| Sponsored by: |
Albert Einstein College of Medicine of Yeshiva University |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00003867 |
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 I trial to study the effectiveness of irinotecan and capecitabine in treating patients who have solid tumors that have not responded to previous treatment.
| Condition | Intervention | Phase |
|---|---|---|
|
Cancer |
Drug: capecitabine Drug: irinotecan hydrochloride |
Phase I |
| Study Type: | Interventional |
| Study Design: | Treatment |
| Official Title: | Phase I Clinical Study of Every Three Week Irinotecan With Oral Capecitabine Given Twice Daily for Two Weeks Out of Three in Patients With Gastrointestinal and Other Solid Malignancies |
| Estimated Enrollment: | 30 |
| Study Start Date: | March 1999 |
OBJECTIVES: I. Determine the maximum tolerated dose and toxic effects of irinotecan and oral capecitabine in patients with gastrointestinal or other solid tumors. II. Characterize the relationship at the recommended phase II dose between thymidine synthase and thymidine phosphorylase expression and tumor response and/or toxic effects in these patients.
OUTLINE: This is a dose escalation study. Patients receive oral capecitabine twice daily every twelve hours for 14 days, and IV irinotecan over 30 minutes once every 3 weeks beginning on day 1. Treatment continues for at least 2 courses in the absence of disease progression or unacceptable toxicity. The dose of capecitabine and irinotecan is escalated in cohorts of 3-6 patients until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which 2 of 6 patients experience dose limiting toxicity.
PROJECTED ACCRUAL: Approximately 25-30 patients will be accrued for this study.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS: Histologically confirmed solid tumors, including but not limited to breast, gastrointestinal, and unknown primary cancer that is refractory to standard therapy or for which no standard therapy exists No known bone marrow involvement
PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 60-100% Life expectancy: Not specified Hematopoietic: Absolute neutrophil count at least 1,500/mm3 OR WBC at least 3,500/mm3 AND Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 1.5 mg/dL No known Gilbert's syndrome No other significant hepatic disease requiring medication Renal: Creatinine no greater than 1.5 mg/dL Cardiovascular: No significant cardiac disease requiring medication Other: Not pregnant or nursing Fertile patients must use effective contraception No other significant medical condition
PRIOR CONCURRENT THERAPY: Biologic therapy: At least 2 weeks since prior colony stimulating factor and other cytokines active on bone marrow Chemotherapy: At least 4 weeks since prior chemotherapy (6 weeks since mitomycin or nitrosoureas) No prior or concurrent irinotecan and fluorouracil therapy Endocrine therapy: Not specified Radiotherapy: At least 4 weeks since prior radiotherapy No concurrent radiotherapy Surgery: Recovered from prior major surgery
Contacts and Locations| United States, New York | |
| Albert Einstein Comprehensive Cancer Center | |
| Bronx, New York, United States, 10461 | |
| Study Chair: | Sridhar Mani, MD | Albert Einstein College of Medicine of Yeshiva University |
More Information
| Study ID Numbers: | CDR0000067031, AECM-1199903068, NCI-V99-1541 |
| Study First Received: | November 1, 1999 |
| Last Updated: | July 23, 2008 |
| ClinicalTrials.gov Identifier: | NCT00003867 History of Changes |
| Health Authority: | United States: Federal Government |
|
stage III colon cancer stage IV colon cancer stage IV breast cancer stage IIIA breast cancer recurrent breast cancer stage III gastric cancer stage IV gastric cancer recurrent gastric cancer stage IIIB breast cancer stage II pancreatic cancer stage III pancreatic cancer recurrent pancreatic cancer stage III rectal cancer stage IV rectal cancer recurrent colon cancer |
recurrent rectal cancer stage IV anal cancer recurrent anal cancer stage II esophageal cancer stage III esophageal cancer stage IV esophageal cancer stage IIIA anal cancer stage IIIB anal cancer recurrent esophageal cancer regional gastrointestinal carcinoid tumor metastatic gastrointestinal carcinoid tumor recurrent gastrointestinal carcinoid tumor localized unresectable adult primary liver cancer advanced adult primary liver cancer recurrent adult primary liver cancer |
|
Antimetabolites Leiomyosarcoma Rectal Neoplasms Pancreatic Neoplasms Esophageal Neoplasms Irinotecan Anal Cancer Bile Duct Cancer, Extrahepatic Liver Neoplasms Stomach Neoplasms Lymphoma Capecitabine Rectal Neoplasm Breast Neoplasms |
Esophageal Cancer Camptothecin Recurrence Carcinoma Gall Bladder Cancer Rectal Cancer Esophageal Disorder Carcinoid Tumor Gallbladder Neoplasms Esophageal Diseases Stomach Cancer Adenocarcinoma Antineoplastic Agents, Phytogenic Anus Neoplasms |
|
Antimetabolites Capecitabine Antimetabolites, Antineoplastic Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Therapeutic Uses |
Irinotecan Enzyme Inhibitors Antineoplastic Agents, Phytogenic Pharmacologic Actions Camptothecin |
