Irinotecan Followed by Fluorouracil in Treating Patients With Advanced Solid Tumors

NCT00024141 | Completed Phase 1 DMC

• 2 other identifiers: CDR0000068895RPCI-RP-01-01
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Unspecified Adult Solid Tumor, Protocol Specific

Keywords

unspecified adult solid tumor, protocol specific

Interventions

fluorouracil DRUG

irinotecan hydrochloride DRUG

Eligibility Criteria

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

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

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

Sponsors & Collaborators

• Roswell Park Cancer Institute: lead

Study Sites (1)

Roswell Park Cancer Institute

Buffalo, New York, 14263-0001, United States

Location

Related Publications (2)

• 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.

  BACKGROUND

• 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.

  RESULT

MeSH Terms

Interventions

Fluorouracil; Irinotecan

Intervention Hierarchy (Ancestors)

Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Camptothecin; Alkaloids

Study Officials

• Patrick J. Creaven, MBBS, PhD

  Roswell Park Cancer Institute

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 13, 2001
• First Posted: June 20, 2003
• Study Start: May 1, 2001
• Primary Completion: September 1, 2002
• Study Completion: January 1, 2003
• Last Updated: March 7, 2011

Record last verified: 2011-03

Locations

US (1)