|
||||||||||||||||||||||
|
|
Phase II Study of Aminocamptothecin for Untreated Metastatic Colorectal Carcinoma (Summary Last Modified 07/98)
Basic Trial Information
Objectives I. Estimate the objective tumor response rate of patients with previously untreated, measurable metastatic colorectal carcinoma treated with aminocamptothecin (9-AC) utilizing two different dose schedules. II. Evaluate the qualitative and quantitative toxic effects of 9-AC given on these two schedules. III. Assess the topoisomerase I expression in pretreatment samples by immunohistochemical staining. Entry Criteria Disease Characteristics: Histologically or cytologically confirmed recurrent or metastatic colorectal cancer for which surgery is not considered curative Histologic confirmation not required provided: Colorectal carcinoma was histologically confirmed previously, pulmonary metastases are clinically diagnosed, and no other lesion is accessible for biopsy AND 2 or more nodular new or progressive lesions on chest x-ray compared to x-rays taken 1-18 months earlier Progression defined as an increase of 25% in the product of perpendicular diameters of any 1 lesion and/or appearance of new lesions Bidimensional clearly measurable disease required, i.e.: At least 1.0 cm on physical exam or chest x-ray At least 3.0 cm on CT or MRI At least 5.0 cm on radioisotope liver scan Hepatomegaly, palpable at least 5 cm below costal margin with tumor involvement documented by biopsy or imaging study (CT or MRI) No CNS metastases Prior/Concurrent Therapy: Biologic therapy: Not specified Chemotherapy: No prior systemic chemotherapy Endocrine therapy: Not specified Radiotherapy: No prior radiotherapy for malignant disease Surgery: At least 21 days since abdominal exploration, with or without intestinal resection Patient Characteristics: Age: Not specified Performance status: ECOG 0-2 Hematopoietic: WBC at least 3,500 Platelets at least 130,000 Hepatic: Bilirubin less than 0.5 mg/dL above normal AST no greater than 3 times normal Renal: Creatinine less than 0.4 mg/dL above normal Cardiovascular: No myocardial infarction within 6 months No current clinical evidence of congestive heart failure Other: No active uncontrolled infection No psychiatric disorder that would preclude informed consent or follow-up No other severe underlying disease that would preclude treatment No second malignancy within 5 years except: Adequately treated nonmelanomatous skin cancer Other adequately treated noninvasive cancer No pregnant or nursing women Effective contraception required of fertile patients Expected Enrollment For both treatment schedules, if at least 1 response is seen in the first 15 patients, an additional 15 patients will be entered; if at least 3 responses are seen in these 30 patients, 15 additional patients will be entered. Accrual will be open to only one schedule at any given time and is expected to require 4-12 months. Outline Single-Agent Chemotherapy. Aminocamptothecin, 9-AC, NSC-603071. Two schedules are assessed: 72-hour infusion q 2 weeks (Schedule A) and 120-hour infusion q 4 weeks (Schedule B; closed to patient entry as of 12/96). Trial Lead Organizations North Central Cancer Treatment Group
Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol. |
NCI Home |
Images Version |
Contact Us |
Policies |
Accessibility |
Viewing Files |
FOIA |
Site Help |
Site Map
|
A Service of the National Cancer Institute |