NCT00215501

Brief Summary

The purpose of this study is to test the safety of irinotecan and cisplatin in combination with either capecitabine or continuous infusion 5-fluorouracil and to see what effects (good and bad) these have on patients with unresectable, advanced solid tumors.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
54

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Nov 2001

Longer than P75 for phase_1

Geographic Reach
1 country

3 active sites

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

November 1, 2001

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2005

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

September 14, 2005

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 22, 2005

Completed
2.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2008

Completed
Last Updated

November 2, 2018

Status Verified

October 1, 2018

Enrollment Period

3.8 years

First QC Date

September 14, 2005

Last Update Submit

October 31, 2018

Conditions

Solid Tumor

Keywords

advanced solid tumor malignancycapecitabinecontinuous infusion5-FUirinotecan5-fluorouracilcisplatin

Outcome Measures

Primary Outcomes (1)

  • To determine dose limiting toxicity, maximum tolerated dose and recommended Phase II dose of both capecitabine and 5-fluorouracil in this patient population.

    2 years

Secondary Outcomes (1)

  • To make a preliminary assessment of the anti-tumor activity of these combinations.

    2 years

Study Arms (2)

Group A

EXPERIMENTAL

Oral capecitabine

Drug: CapecitabineDrug: IrinotecanDrug: Cisplatin

Group B

EXPERIMENTAL

5-fluorouracil

Drug: 5-Fluorouracil (5-FU)Drug: IrinotecanDrug: Cisplatin

Interventions

CapecitabineDRUG

Orally twice a day for 14 days (dosage will vary)

Group A
5-Fluorouracil (5-FU)DRUG

Continuous infusion 24 hours a day for 14 days (Days 1-14) Dosage will vary

Group B
IrinotecanDRUG

Intravenously weekly for 2 weeks (given after cisplatin) followed by a one-week rest period

Group AGroup B
CisplatinDRUG

Intravenously weekly for 2 weeks followed by a one week rest period

Group AGroup B

Eligibility Criteria

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

You may qualify if:

  • Histologically confirmed solid tumor malignancy
  • years of age or older
  • Two prior chemotherapy regimens for metastatic disease. Prior chemotherapy must have been completed at least 3 weeks prior to initiation of this protocol.
  • ECOG performance status of 0,1 or 2
  • Neutrophils greater or equal to 1,500/ul
  • Platelets greater or equal to 100,000/ul
  • Serum bilirubin less or equal to 1.5 mg/dl
  • Creatinine clearance greater than 50 ml/min
  • AST or SGOT less or equl to 3x ULN
  • Prior radiotherapy is allowable, provided at least 4 weeks have elapsed and the patient has recovered from all therapy related side effects.

You may not qualify if:

  • Life expectancy of less than 3 months
  • Clinically significant cardiac disease or myocardial infarction within past 6 months
  • Suspicion or documentation of CNS metastases or carcinomatous meningitis
  • Psychiatric disability judged by the investigator to be clinically significant, precluding informed consent
  • Known existing coagulopathy and/or requires therapeutic anticoagulants
  • Uncontrolled diarrhea
  • Peripheral neuropathy
  • Major surgery within 3 weeks of the state of the study treatment without complete recovery
  • Serious, uncontrolled, concurrent infection
  • Lack of physical integrity of upper gastrointestinal tract or malabsorption syndrome
  • Prior severe reaction to fluoropyrimidine, irinotecan or cisplatin
  • Known interstitial pulmonary fibrosis
  • Known Gilbert's disease
  • Uncontrolled diabetes mellitus
  • Organ allograft(s) on immunosuppressive therapy
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Dana-Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Interventions

CapecitabineFluorouracilIrinotecanCisplatin

Intervention Hierarchy (Ancestors)

DeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsUracilPyrimidinonesDeoxyribonucleosidesNucleosidesNucleic Acids, Nucleotides, and NucleosidesCamptothecinAlkaloidsChlorine CompoundsInorganic ChemicalsNitrogen CompoundsPlatinum Compounds

Study Officials

  • Peter C. Enzinger, MD

    Dana-Farber Cancer Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 14, 2005

First Posted

September 22, 2005

Study Start

November 1, 2001

Primary Completion

September 1, 2005

Study Completion

September 1, 2008

Last Updated

November 2, 2018

Record last verified: 2018-10

Locations

US(3)