Know Cancer

forgot password

Phase I/II Trial Of Weekly Irinotecan And Docetaxel With The Addition Of Celecoxib In Advanced Non-Small Cell Lung Cancer

Phase 1/Phase 2
18 Years
Not Enrolling
Lung Cancer

Thank you

Trial Information

Phase I/II Trial Of Weekly Irinotecan And Docetaxel With The Addition Of Celecoxib In Advanced Non-Small Cell Lung Cancer


- Determine the recommended phase II dose of docetaxel and irinotecan in combination with
celecoxib in patients with advanced non-small cell lung cancer.

- Determine the toxic effects of this regimen in these patients.

- Determine the response rate of patients treated with this regimen.

- Determine the progression-free and overall survival of patients treated with this

- Determine the pharmacokinetics of this regimen in these patients.

- Correlate angiogenesis markers (intratumoral microvessel density and vascular
endothelial growth factor [VEGF] expression and serum VEGF) and cyclooxygenase-2
expression with response and survival in patients treated with this regimen.

- Correlate UGT1A1 genotype and CYP3A4 activity with the toxic effects of this regimen in
these patients.

OUTLINE: This is a dose-escalation study of docetaxel and irinotecan.

- Phase I: Patients receive docetaxel IV over 60 minutes and irinotecan IV over 30
minutes on days 1 and 8. Patients also receive oral celecoxib twice daily beginning on
day 2. Courses repeat every 21 days in the absence of disease progression or
unacceptable toxicity Cohorts of 3-6 patients receive escalating doses of docetaxel and
irinotecan until the recommended phase II dose is determined. The recommended phase II
dose is defined as the highest dose at which 0 of 3 or 1 of 6 patients experience
dose-limiting toxicity.

- Phase II: Patients receive treatment as in phase I at the recommended phase II dose.

Patients are followed every 3 months until disease progression.

PROJECTED ACCRUAL: A total of 3-70 patients (3-36 for phase I and 16-34 for phase II) will
be accrued for this study.

Inclusion Criteria


- Diagnosis of non-small cell lung cancer (NSCLC) meeting 1 of the following criteria:

- Stage IV

- Stage IIIB with a malignant pleural effusion

- Locally recurrent and/or persistent disease after locoregional therapy with or
without systemic chemotherapy

- Unidimensionally measurable disease

- If the only site of measurable disease is in a previously irradiated area must
have documented progression of disease in that area

- No CNS metastases



- 18 and over

Performance status

- ECOG 0-2

Life expectancy

- Not specified


- Absolute neutrophil count at least 1,500/mm^3

- Platelet count at least 100,000/mm^3


- Bilirubin normal

- AST and ALT less than 2.5 times upper limit of normal (ULN) (if alkaline phosphatase
is normal)

- Alkaline phosphatase less than 4 times ULN (if AST and ALT are normal)


- Creatinine less than 2.0 mg/dL


- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception during and for 3 months after study

- No other malignancy within the past 5 years except curatively treated squamous cell
or basal cell skin cancer or carcinoma in situ of the cervix

- No diagnosis of peptic ulcer disease or gastritis/esophagitis within the past 60 days

- No prior hypersensitivity to cyclooxygenase-2 (COX-2) inhibitors, nonsteroidal
anti-inflammatory drugs (NSAIDs), salicylates, sulfonamides, or drugs formulated with
polysorbate 80

- No pre-existing grade 2 or greater peripheral neuropathy

- No concurrent medical condition that would preclude study compliance


Biologic therapy

- At least 1 week since prior biologic therapy

- Phase I patients:

- Any number of prior biologic therapies allowed (e.g., chimeric antibodies or
kinase inhibitors)

- Phase II patients:

- No prior biologic therapy for recurrent/metastatic disease

- No concurrent filgrastim (G-CSF)


- See Disease Characteristics

- At least 4 weeks since prior chemotherapy

- No prior irinotecan or docetaxel

- Phase I patients:

- Up to 2 prior chemotherapy regimens for recurrent/metastatic disease allowed
(chemonaïve patients are also eligible)

- Phase II patients:

- At least 1 year since prior adjuvant or neoadjuvant chemotherapy for stage
I-IIIA disease

- No prior chemotherapy for recurrent/metastatic disease

Endocrine therapy

- Less than 2 weeks of cumulative oral/IV corticosteroid use within the past 3 months


- See Disease Characteristics

- Recovered from prior radiotherapy

- At least 3 weeks since prior extensive-field radiotherapy for recurrent/metastatic


- Recovered from prior surgery


- More than 60 days since prior treatment for peptic ulcer disease or

- No prior NSAIDs at a frequency of more than 3 times per week for a cumulative period
of more than 2 weeks within the past 30 days

- No concurrent antiepileptics, cyclosporine, aspirin, or fluconazole

- No concurrent NSAIDs

- No other concurrent COX-2 inhibitors

Type of Study:


Study Design:

Primary Purpose: Treatment

Principal Investigator

Athanassios Argiris, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Robert H. Lurie Cancer Center


United States: Federal Government

Study ID:

NU 01L2



Start Date:

June 2003

Completion Date:

December 2004

Related Keywords:

  • Lung Cancer
  • recurrent non-small cell lung cancer
  • stage IIIB non-small cell lung cancer
  • stage IV non-small cell lung cancer
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms



Evanston Northwestern Health Care - Evanston Hospital Evanston, Illinois  60201
Robert H. Lurie Comprehensive Cancer Center at Northwestern University Chicago, Illinois  60611
Silver Cross Hospital Joliet, Illinois  60432