Irinotecan Followed by Fluorouracil in Treating Patients With Advanced Solid Tumors
This study has been completed.
Sponsor:
Roswell Park Cancer Institute
Information provided by:
Roswell Park Cancer Institute
ClinicalTrials.gov Identifier:
NCT00024141
First received: September 13, 2001
Last updated: March 3, 2011
Last verified: March 2011
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Purpose
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Phase I trial to study the effectiveness of irinotecan followed by fluorouracil in treating patients who have advanced solid tumors.
| Condition | Intervention | Phase |
|---|---|---|
|
Unspecified Adult Solid Tumor, Protocol Specific |
Drug: fluorouracil Drug: irinotecan hydrochloride |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Primary Purpose: Treatment |
| Official Title: | 5-Flourouracil Preceded by Irinotecan In Patients With Advanced Solid Tumors: A Pilot Study |
Resource links provided by NLM:
Further study details as provided by Roswell Park Cancer Institute:
| Study Start Date: | May 2001 |
| Study Completion Date: | January 2003 |
| Primary Completion Date: | September 2002 (Final data collection date for primary outcome measure) |
OBJECTIVES:
- Determine the optimal dose of irinotecan when administered before fluorouracil in patients with advanced solid tumors.
- Determine the toxic effects of this regimen in these patients.
- Correlate the pharmacokinetics of irinotecan with its biologic effects in these patients.
- Assess, in a preliminary manner, the antitumor activity of this regimen in these patients.
OUTLINE: This is a dose de-escalation study of irinotecan.
Patients receive irinotecan IV over 90 minutes on days 1, 8, 15, and 22 and fluorouracil IV over 5 minutes on days 2, 9, 16, and 23. Treatment repeats every 6 weeks in the absence of disease progression or unacceptable toxicity.
Cohorts of 6 patients receive decreasing doses of irinotecan until the optimal dose is determined. The optimal dose is defined as the dose at which at least 3 of 6 patients show evidence of recruitment of cells into the S phase at 24 hours after irinotecan administration.
PROJECTED ACCRUAL: A total of 18-24 patients will be accrued for this study within 12-18 months.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
DISEASE CHARACTERISTICS:
- Histologically proven recurrent or metastatic solid tumor that is not amenable to curative surgery, radiotherapy, or conventional chemotherapy of proven value
- Must have disease that can be safely and readily biopsied under local anesthesia (including, but not limited to, subcutaneous metastases, superficial lymph node metastases, or ascites)
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Performance status:
- ECOG 0-2
Life expectancy:
- At least 3 months
Hematopoietic:
- WBC at least 4,000/mm^3
- Platelet count at least 100,000/mm^3
Hepatic:
- Bilirubin no greater than 1.5 times upper limit of normal (ULN)
- AST less than 2 times ULN
- Alkaline phosphatase less than 2 times ULN
- Lactic dehydrogenase less than 2 times ULN
Renal:
- Creatinine no greater than 1.5 times ULN
Other:
- HIV negative
- No active uncontrolled bacterial, viral, or fungal infection
- No nonmalignant systemic disease that would preclude study participation
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- Not specified
Chemotherapy:
- See Disease Characteristics
- At least 3 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin)
- No prior irinotecan
Endocrine therapy:
- Not specified
Radiotherapy:
- See Disease Characteristics
- At least 4 weeks since prior radiotherapy except small-port radiotherapy for local control
- No concurrent radiotherapy except small-port radiotherapy for local disease control (e.g., pain relief or impending fracture)
Surgery:
- See Disease Characteristics
- At least 2 weeks since prior major surgery
Other:
- No concurrent anticoagulants except warfarin or subcutaneous heparin
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00024141
Locations
| United States, New York | |
| Roswell Park Cancer Institute | |
| Buffalo, New York, United States, 14263-0001 | |
Sponsors and Collaborators
Roswell Park Cancer Institute
Investigators
| Study Chair: | Patrick J. Creaven, MBBS, PhD | Roswell Park Cancer Institute |
More Information
Additional Information:
Publications:
Creaven PJ, Slocum HK, Toth K, et al.: Modulation of 5-fluorouracil by irinotecan in advanced solid tumors: a pilot study. [Abstract] Int J Cancer 100 (Suppl 13): A-O78, 94, 2002.
Ramnath N, Creaven PJ, Khushalani N, et al.: Pilot studies of antimetabolites preceeded by irinotecan in advanced solid tumors. [Abstract] Eur J Cancer 38 (Suppl 7): S44-5, 2002.
| Responsible Party: | Patrick Creaven, MD, Institutional Review Board |
| ClinicalTrials.gov Identifier: | NCT00024141 History of Changes |
| Other Study ID Numbers: | CDR0000068895, RPCI-RP-01-01 |
| Study First Received: | September 13, 2001 |
| Last Updated: | March 3, 2011 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Roswell Park Cancer Institute:
|
unspecified adult solid tumor, protocol specific |
Additional relevant MeSH terms:
|
Neoplasms Fluorouracil Irinotecan Camptothecin Antimetabolites Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antimetabolites, Antineoplastic Antineoplastic Agents |
Therapeutic Uses Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Antineoplastic Agents, Phytogenic Radiation-Sensitizing Agents Topoisomerase I Inhibitors Topoisomerase Inhibitors Enzyme Inhibitors |
ClinicalTrials.gov processed this record on May 16, 2013