NCT00001495

Brief Summary

This study examines a 96 hour infusion schedule of irinotecan alternating with 72 hour drug-free intervals in patients with solid tumors in order to determine the maximum tolerated dose of this regimen.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Nov 1995

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 1995

Completed
4 years until next milestone

First Submitted

Initial submission to the registry

November 3, 1999

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2000

Completed
2.2 years until next milestone

First Posted

Study publicly available on registry

December 10, 2002

Completed
Last Updated

March 4, 2008

Status Verified

September 1, 1999

First QC Date

November 3, 1999

Last Update Submit

March 3, 2008

Conditions

Neoplasms

Keywords

CamptothecinCancerChemotherapyNatural ProductsNeoplasms

Interventions

irinotecan (CPT-11)DRUG

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: Recurrent or metastatic cancer, including lymphoma. No leukemia. No active CNS disease. Refractory to all effective therapy OR No effective therapy exists. Measurable disease not required. PRIOR/CONCURRENT THERAPY: Biologic Therapy: Greater than 4 weeks and recovered from immunotherapy. Chemotherapy: Greater than 4 weeks and recovered from chemotherapy. Previous therapy with irinotecan is permitted. Endocrine Therapy: Not specified. Radiotherapy: Greater than 4 weeks since radiotherapy. Surgery: Recovered from prior surgery. PATIENT CHARACTERISTICS: Age: 18 and over. Performance status: ECOG 0-2. Hematopoietic: AGC greater than 1,500. Platelets greater than 100,000. Hepatic: Bilirubin no greater than 1.5 mg/dL. AST no greater than 2 times normal. Renal: Creatinine no greater than 1.5 mg/dL. OTHER: HIV negative. No active infection requiring antibiotics. No concurrent medical illness that would interfere with chemotherapy. No pregnant or nursing women. Adequate contraception required of fertile patients. Imaging/exams for tumor measurement within 28 days prior to registration.

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

Sponsors & Collaborators

Study Sites (1)

National Cancer Institute (NCI)

Bethesda, Maryland, 20892, United States

Location

Related Publications (2)

  • Negoro S, Fukuoka M, Masuda N, Takada M, Kusunoki Y, Matsui K, Takifuji N, Kudoh S, Niitani H, Taguchi T. Phase I study of weekly intravenous infusions of CPT-11, a new derivative of camptothecin, in the treatment of advanced non-small-cell lung cancer. J Natl Cancer Inst. 1991 Aug 21;83(16):1164-8. doi: 10.1093/jnci/83.16.1164.

    PMID: 1653362BACKGROUND

  • de Forni M, Bugat R, Chabot GG, Culine S, Extra JM, Gouyette A, Madelaine I, Marty ME, Mathieu-Boue A. Phase I and pharmacokinetic study of the camptothecin derivative irinotecan, administered on a weekly schedule in cancer patients. Cancer Res. 1994 Aug 15;54(16):4347-54.

    PMID: 8044782BACKGROUND

MeSH Terms

Conditions

Neoplasms

Interventions

Irinotecan

Intervention Hierarchy (Ancestors)

CamptothecinAlkaloidsHeterocyclic Compounds

Study Design

Study Type
interventional
Phase
phase 1
Purpose
TREATMENT
Sponsor Type
NIH

Study Record Dates

First Submitted

November 3, 1999

First Posted

December 10, 2002

Study Start

November 1, 1995

Study Completion

October 1, 2000

Last Updated

March 4, 2008

Record last verified: 1999-09

Locations

US(1)