NCT00165464

Brief Summary

This is a phase II study of taxotere, cisplatin and irinotecan (CPT-11) used in combination to treat metastatic esophageal and gastric cancer in an effort to see what effects (good and bad) the combination may have on the patients cancer.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
54

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Aug 2001

Longer than P75 for phase_2

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

August 1, 2001

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2005

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

September 9, 2005

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 14, 2005

Completed
3.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2009

Completed
Last Updated

April 28, 2009

Status Verified

April 1, 2009

Enrollment Period

3.6 years

First QC Date

September 9, 2005

Last Update Submit

April 24, 2009

Conditions

Esophageal CancerGastric CancerGE Junction Cancer

Keywords

Esophageal CancerGastric CancerGE JunctionCisplatinTaxotereCPT-11Irinotecan

Outcome Measures

Primary Outcomes (1)

  • To assess the response rate of patients with esophageal or gastric carcinoma to weekly Taxotere, Cisplatin, and Irinotecan (CPT-11).

Secondary Outcomes (2)

  • To assess the duration of response and overall survival of patients with esophageal or gastric carcinoma to weekly Taxotere, Cisplatin, and Irinotecan.

  • To assess the toxicity of this combination in esophageal or gastric carcinoma.

    4 years

Interventions

TaxotereDRUG

Given once weekly for 2 weeks followed by a one week rest period (1 cycle is 3 weeks) Participants may continue on treatment unless there is disease progression or intolerable toxicities.

CisplatinDRUG

Given once weekly for 2 weeks followed by a one week rest period (1 cycle is 3 weeks) Participants may continue on treatment unless there is disease progression or intolerable toxicities.

IrinotecanDRUG

Given once weekly for 2 weeks followed by a one week rest period (1 cycle is 3 weeks) Participants may continue on treatment unless there is disease progression or intolerable toxicities.

Eligibility Criteria

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

You may qualify if:

  • Histologically confirmed, incurable esophageal or gastric carcinoma (carcinoma = adenocarcinoma or squamous cell carcinoma)
  • Measurable disease \> 1cm (longest diameter) by spiral CT scan or \> 2cm by other radiographic technique.
  • Lesions must be measurable in at least one dimension.
  • Bone lesions, ascites and effusions are not measurable.
  • Irradiated lesions are not measurable yet lesions arising in previously irradiated fields are measurable.
  • Age 18+ years.
  • ECOG performance status 0 or 1.
  • Life expectancy greater than 12 weeks.
  • Adequate bone marrow function.
  • Adequate renal function: creatinine equal to or less than 1.5 mg/dl.
  • SGOT less than 2.5 x institutional upper limit of normal if alkaline phosphatase is within institutional upper limit of normal.
  • Alkaline phosphatase less than 4.0 x upper limit of normal if SGOT is within institutional upper limit of normal.
  • For patients with both SGOT and alkaline phosphatase elevations, SGOT must be less than 1.5 x institutional upper limit of normal and alkaline phosphatase must be less 2.5 x institutional upper limit of normal. For patients with liver metastases, however, SGOT may be \< 3.0 x institutional upper limit of normal and alkaline phosphatase may be \< 5.0 x institutional upper limit of normal as long as the total bilirubin is within the institutional upper limit of normal.

You may not qualify if:

  • No prior chemotherapy (except as part of pre- or post-operative therapy, completed \> 1 year prior to start date of this protocol).
  • Patients who have received prior pelvic radiation therapy are ineligible. Other prior radiation therapy, however, is permitted, provided at least 4 weeks have elapsed since completion of this therapy and the initiation of this protocol.
  • No myocardial infarction in the past six months.
  • No major surgery in the past three weeks.
  • No uncontrolled serious medical or psychiatric illness.
  • No uncontrolled diarrhea.
  • Patients with a peripheral neuropathy \> grade 1 will be excluded.
  • Women of childbearing potential must have a negative pregnancy test. Men and women of childbearing potential must use adequate contraception.
  • No clinically apparent central nervous system metastases or carcinomatous meningitis.
  • No other active malignancy other than non-melanoma skin cancer or in-situ cervical carcinoma. A resected cancer (other than in-situ carcinoma) must have demonstrated no evidence of recurrence for at least 3 years.
  • Patients with history of severe hypersensitivity to irinotecan, cisplatin, taxotere or drugs formulated with polysorbate 80 must be excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02115, United States

Location

Faulkner Hospital

Boston, Massachusetts, 02130, United States

Location

Related Publications (1)

  • Enzinger PC, Ryan DP, Clark JW, Muzikansky A, Earle CC, Kulke MH, Meyerhardt JA, Blaszkowsky LS, Zhu AX, Fidias P, Vincitore MM, Mayer RJ, Fuchs CS. Weekly docetaxel, cisplatin, and irinotecan (TPC): results of a multicenter phase II trial in patients with metastatic esophagogastric cancer. Ann Oncol. 2009 Mar;20(3):475-80. doi: 10.1093/annonc/mdn658. Epub 2009 Jan 12.

    PMID: 19139178RESULT

MeSH Terms

Conditions

Esophageal NeoplasmsStomach Neoplasms

Interventions

DocetaxelCisplatinIrinotecan

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsHead and Neck NeoplasmsDigestive System DiseasesEsophageal DiseasesGastrointestinal DiseasesStomach Diseases

Intervention Hierarchy (Ancestors)

TaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenesChlorine CompoundsInorganic ChemicalsNitrogen CompoundsPlatinum CompoundsCamptothecinAlkaloidsHeterocyclic Compounds

Study Officials

  • Peter C. Enzinger, MD

    Dana-Farber Cancer Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 9, 2005

First Posted

September 14, 2005

Study Start

August 1, 2001

Primary Completion

March 1, 2005

Study Completion

April 1, 2009

Last Updated

April 28, 2009

Record last verified: 2009-04

Locations

US(3)