Celecoxib and Docetaxel in Treating Patients With Advanced Non-Small Cell Lung Cancer

Lung Cancer Clinical Trial

Official title:

Evaluation Of Celecoxib In Combination With Docetaxel In The Treatment Of Advanced Non-Small Cell Lung Cancer Patients Previously Treated With Platinum Based Chemotherapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00030420
• Other study ID #: CDR0000069164
• Secondary ID: P30CA022453WSU-C
• Status: Completed
• Phase: Phase 2
• First received: February 14, 2002
• Last updated: April 25, 2013
• Start date: October 2001
• Est. completion date: February 2008

Study information

• Verified date: April 2013
• Source: Barbara Ann Karmanos Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal GovernmentUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

RATIONALE: Celecoxib may slow the growth of cancer by stopping blood flow to the tumor. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with celecoxib may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of combining celecoxib and docetaxel in treating patients who have advanced non-small cell lung cancer that has been previously treated with platinum-based chemotherapy.

Description:

OBJECTIVES:

• Determine the efficacy and feasibility of celecoxib combined with docetaxel in patients with advanced non-small cell lung cancer previously treated with platinum-based chemotherapy.

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

• Determine the toxicity of this regimen in these patients.

OUTLINE: This is a multicenter study.

Patients receive oral celecoxib twice daily (beginning on day -7 of the first course) and docetaxel IV over 1 hour on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity. Patients who achieve a complete response (CR) receive 2 additional courses after CR. Patients who achieve stable disease (SD) or a partial response (PR) receive a minimum of 2 additional courses after SD or PR. At the discretion of the treating physician, patients then receive maintenance therapy comprising celecoxib only.

Patients who discontinue therapy for disease progression or unacceptable toxicity are followed for at least 6 months.

PROJECTED ACCRUAL: A total of 21-39 patients will be accrued for this study within 13-28 months.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: February 2008
• Est. primary completion date: May 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

DISEASE CHARACTERISTICS:

• Diagnosis of stage IIIA, IIIB, or IV non-small cell lung cancer

• Disease progression during or after 1 or more platinum-based chemotherapy regimens

• Measurable or evaluable disease

• No symptomatic or untreated brain or leptomeningeal metastases

• Previously treated patients must be neurologically stable for 4 weeks after completion of appropriate therapy

PATIENT CHARACTERISTICS:

Age:

• 18 and over

Performance status:

• SWOG 0-2

Life expectancy:

• Not specified

Hematopoietic:

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

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

• Hemoglobin at least 8 g/dL

Hepatic:

• Bilirubin no greater than upper limit of normal (ULN)

• AST/ALT no greater than ULN (or no greater than 2.5 times ULN if alkaline phosphatase no greater than ULN)

• Alkaline phosphatase no greater than ULN (or no greater than 5 times ULN if AST/ALT no greater than ULN)

• No history of chronic hepatitis of any duration

Renal:

• Creatinine no greater than ULN

Cardiovascular:

• No uncontrolled congestive heart failure

• No uncontrolled angina

• No myocardial infarction and/or stroke within the past 6 months

• No active thromboembolic event within the past 4 weeks

Gastrointestinal:

• No gastrointestinal bleeding within the past 6 months

• No history of peptic ulcer disease

Other:

• No prior hypersensitivity reaction to docetaxel or other drugs formulated with polysorbate 80

• No prior allergy to any non-steroidal anti-inflammatory drug

• No other prior or concurrent malignancy within the past 3 years except adequately treated squamous cell or basal cell skin cancer or carcinoma in situ of the cervix

• No grade 2 or greater peripheral neuropathy

• No active infection

• No other serious concurrent medical illness

• No history of dementia, active psychiatric disorder, or other condition that would interfere with ability to take oral medication or preclude compliance with study

• HIV negative

• Must weigh at least 50 kg (110 pounds)

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective barrier contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• Not specified

Chemotherapy:

• See Disease Characteristics

• At least 4 weeks since prior chemotherapy

• Prior paclitaxel allowed

• No prior docetaxel

Endocrine therapy:

• At least 3 days since prior steroids

Radiotherapy:

• At least 4 weeks since prior radiotherapy

• No prior radiotherapy to target lesion

Surgery:

• At least 4 weeks since prior major surgery

Other:

• Prior intermittent use of non-steroidal anti-inflammatory drugs (NSAIDs), including rofecoxib or celecoxib, allowed

• At least 1 week since prior fluconazole

• No recent prior NSAIDs, including rofecoxib or celecoxib, for a duration of more than 30 consecutive days

• No concurrent fluconazole or lithium

• No other concurrent NSAIDs except aspirin administered at a dose of no more than 325 mg/day for cardiovascular conditions

• No other concurrent cyclo-oxygenase-2 inhibitors

• No other concurrent investigational agents

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Cancer
• Lung Neoplasms

Intervention

Drug:
• Celecoxib
400mg by mouth, twice a day, each dose given with meals, to start -7 days prior to first cycle of treatment.
• Docetaxel
On day 1, 75mg/m2 IV over 60 minutes, repeated every 21 days

Locations

Country	Name	City	State
United States	Barbara Ann Karmanos Cancer Institute	Detroit	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
Barbara Ann Karmanos Cancer Institute	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

References & Publications (1)

Schneider BJ, Kalemkerian GP, Kraut MJ, Wozniak AJ, Worden FP, Smith DW, Chen W, Gadgeel SM. Phase II study of celecoxib and docetaxel in non-small cell lung cancer (NSCLC) patients with progression after platinum-based therapy. J Thorac Oncol. 2008 Dec;3 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy of combining Celecoxib with Docetaxel	Blood levels of VEGF & PGE2	Weeks 1 , 2 and 3	No
Secondary	Response rate of Celecoxib and Docetaxel	CT Chest/Abdomen	Every 2 cycles (or every 42 days); After therapy is completed or if the patient is only on Celecoxib, will be assessed for progression every month by clinical exam and every 3 months by radiological evaluation.	No
Secondary	Toxicity of Celecoxib and Docetaxel	Routine bloodwork	Every week	Yes
Secondary	Expression of cyclooxygenase-2 (COX-2) in tumors	Tissue sample from initial diagnosis, parrafin embedded tissue block	Pre-study	No
Secondary	Changes in plasma levels of prostaglandin E2 (PGE2) & vascular endthelial growth factor (VEGF)	Collecting blood plasma	Pre-study; Weeks 1 , 2 and 3	No
Secondary	Vascular changes induced in the tumor by celecoxib	Using DCE-MRI and PET scans to evaluate.	Weeks 1, 3 & 6	No