NCT00046917

Brief Summary

Phase I trial to study the effectiveness of combining alvocidib, irinotecan hydrochloride, and cisplatin in treating patients who have advanced solid tumors. 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.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
13

participants targeted

Target at below P25 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2002

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

October 3, 2002

Completed
4 months until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
7.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2010

Completed
Last Updated

February 24, 2014

Status Verified

October 1, 2011

Enrollment Period

7.7 years

First QC Date

October 3, 2002

Last Update Submit

February 21, 2014

Conditions

Unspecified Adult Solid Tumor, Protocol Specific

Outcome Measures

Primary Outcomes (1)

  • MTD alvocidib when administered in conjunction with irinotecan hydrochloride and cisplatin

    Defined as the dose one level below the dose at which two or more of the patients in the initial cohort experience dose limiting toxicity (DLT) during the first treatment course. DLT is defined as the occurrence of Grade 4 hematologic toxicity, Grade 3 or 4 non-hematologic toxicity including diarrhea despite antidiarrheal prophylaxis, or any delay in treatment resulting in less than 2 treatments in 3 weeks.

    Course 1

Secondary Outcomes (3)

  • Clinical pharmacokinetics of the regimen

    Week 1 of courses 1 and 2

  • Therapeutic activity of alvocidib in combination with irinotecan hydrochloride in patients with advanced solid tumors

    After 2 courses of treatment

  • Safety and tolerability

    Weekly

Study Arms (1)

Treatment (chemotherapy)

EXPERIMENTAL

Patients are stratified according to the number of prior treatment regimens (0 or 1 vs more than 1). Patients receive irinotecan hydrochloride IV over 30 minutes followed immediately by cisplatin IV over 30 minutes followed 7 hours later by alvocidib IV over 1-4.5 hours weekly for 2 weeks. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.

Drug: alvocidibDrug: irinotecan hydrochlorideDrug: cisplatin

Interventions

alvocidibDRUG

Given IV

Also known as: FLAVO, flavopiridol, HMR 1275, L-868275
Treatment (chemotherapy)
irinotecan hydrochlorideDRUG

Given IV

Also known as: Campto, Camptosar, CPT-11, irinotecan, U-101440E
Treatment (chemotherapy)
cisplatinDRUG

Given IV

Also known as: CACP, CDDP, CPDD, DDP
Treatment (chemotherapy)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Histologically confirmed locally advanced or metastatic solid tumor that is refractory to standard therapy or for which no standard therapy exists
  • Evaluable disease
  • No previously untreated CNS metastasis
  • No primary CNS tumors
  • Performance status - Karnofsky 60-100%
  • Performance status - ECOG 0-2
  • Not specified
  • WBC at least 3,000/mm\^3
  • Neutrophil count at least 1,500/mm\^3
  • Platelet count at least 100,000/mm\^3
  • Bilirubin no greater than 2.0 mg/dL
  • AST and ALT no greater than 3 times upper limit of normal (ULN) (5 times ULN if liver metastases are present)
  • Creatinine no greater than 1.5 mg/dL
  • Creatinine clearance at least 60 mL/min
  • No cardiac arrhythmia
  • +18 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Memorial Sloan-Kettering Cancer Center

New York, New York, 10065, United States

Location

MeSH Terms

Interventions

alvocidibIrinotecanCisplatin

Intervention Hierarchy (Ancestors)

CamptothecinAlkaloidsHeterocyclic CompoundsChlorine CompoundsInorganic ChemicalsNitrogen CompoundsPlatinum Compounds

Study Officials

  • Manish Shah

    Memorial Sloan Kettering Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 3, 2002

First Posted

January 27, 2003

Study Start

July 1, 2002

Primary Completion

March 1, 2010

Last Updated

February 24, 2014

Record last verified: 2011-10

Locations

US(1)