NCT00819728

Brief Summary

The main purpose of the study is to determine the activity of the weekly combination of docetaxel (Taxotere) and irinotecan in terms of response rate in subjects with advanced, previously untreated, non-small cell lung cancer. It is also to determine the activity of this combination in terms of response duration, time to progression, median survival, overall survival, and percent one-year survival, as well as the side-effect and toxicity profile of weekly Taxotere and weekly irinotecan.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
35

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jun 2000

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

June 1, 2000

Completed
2.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2003

Completed
6 years until next milestone

First Submitted

Initial submission to the registry

January 7, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 9, 2009

Completed
Last Updated

January 11, 2011

Status Verified

January 1, 2011

First QC Date

January 7, 2009

Last Update Submit

January 10, 2011

Conditions

Carcinoma, Non-Small-Cell Lung

Study Arms (1)

Taxotere/Irinotecan

EXPERIMENTAL
Drug: DocetaxelDrug: Irinotecan

Interventions

DocetaxelDRUG

35mg/m2 IV each week for 4 weeks

Also known as: Taxotere
Taxotere/Irinotecan
IrinotecanDRUG

50mg/m2 IV each week for 4 weeks

Taxotere/Irinotecan

Eligibility Criteria

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

You may qualify if:

  • Microscopically or cytologically confirmed non-small cell lung cancer. Histology may include large cell, squamous cell, undifferentiated, or bronchioalveolar carcinoma, or adenocarcinoma, but no small cell or carcinoid.
  • Inoperable stage III B or metastatic stage IV NSCLC
  • Measurable (bidimensionally) indicator lesion(s) which have not been irradiated.
  • No prior systemic chemotherapy. Prior irradiation for NSCLC is permitted, however, the measurable or evaluable non-measurable disease must be completely outside the radiation portal or there must be radiologic proof of progressive disease. If a patient is receiving palliative radiation, other than the chest, to one site at 30 cGy or less, then the patient is eligible and chemotherapy can proceed immediately after palliative RT.
  • ECOG performance status 0 or 1 at screening and on the first day of treatment
  • Life expectancy = 12 weeks.
  • Patients must be \> 4 weeks from prior radiation therapy to the pelvis, spine or long bones, and must be recovered from all side effects.
  • Patients must be \> 3 weeks from prior major surgery, except for a simple biopsy or placement of a venous access device.

You may not qualify if:

  • No patient may have the following:
  • Neutrophils \< 1,500/mm3.
  • Platelets \< 100,000/mm3.
  • Serum creatinine \>1.8 mg/dL.
  • SGOT \> 1.5 times the upper limit of normal for institution.
  • Total bilirubin \> the upper limit of normal for institution.
  • Alkaline phosphatase \> 5 times the upper limit of normal for institution.
  • Pregnant or lactating females or females of childbearing potential not employing adequate contraception.
  • History of other malignancy within the last five years which could affect the diagnosis of NSCLC, except basal cell carcinoma of the skin or carcinoma in situ of the cervix.
  • Current metastatic CNS disease, if present, must have been treated and clinically stable for at least 3 weeks prior to initial Taxotere treatment. Patients with documented meningeal carcinomatosis are not eligible.
  • Grade 2 or greater peripheral neuropathy.
  • Psychological, familial, sociological or geographical conditions which do not permit weekly medical follow-up and compliance with the study protocol.
  • Patients who are medically unstable, including but not limited to active infection, acute hepatitis, gastrointestinal bleeding, uncontrolled cardiac arrhythmias, uncontrolled angina, uncontrolled hypercalcemia, uncompensated congestive heart failure, uncontrolled diabetes, dementia, seizures, superior vena cava syndrome, and patients whose circumstances do not permit completion of the study or the required follow-up.
  • Patients with a history of hypersensitivity reaction to products containing Polysorbate 80 (Tween 80).
  • Patients requiring concurrent treatment with corticosteroids unless chronic treatment (\> 6 months) at low doses (\< 20 mg/day of methylprednisolone or equivalent).
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sanofi-Aventis US

Bridgewater, New Jersey, 08807, United States

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

DocetaxelIrinotecan

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

TaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenesCamptothecinAlkaloidsHeterocyclic Compounds

Study Officials

  • Yasir Nagarwala, MD

    Sanofi

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

January 7, 2009

First Posted

January 9, 2009

Study Start

June 1, 2000

Study Completion

January 1, 2003

Last Updated

January 11, 2011

Record last verified: 2011-01

Locations

US(1)