CPT-11/Cisplatin and Celecoxib With Radiation Therapy for Patients With Unresectable Non-Small Cell Lung Cancer (NSCLC)

NCT00346801 | Completed Phase 1

• 1 other identifier: 2003-0352
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Primary Objectives:

• To determine the feasibility, activity, and toxicity of a novel regimen using a concurrent irinotecan (CPT-11)/cisplatin and celecoxib combination for patients with unresectable NSCLC.
• To determine the maximal tolerance dose of celecoxib in patients with unresectable NSCLC treated with irinotecan/cisplatin and concurrent thoracic radiation therapy.
• To correlate the COX-2 expression and other biomarkers with response to the treatment in the tumor from a pretreatment biopsy specimen.

Conditions

Lung Cancer

Keywords

Non-Small Cell Lung Cancer; Lung Cancer; Celecoxib; Cisplatin; Platinol; CPT-11; Irinotecan; SC-58635; Celebrex; Radiation Therapy

Outcome Measures

Primary Outcomes (1)

• Maximum Tolerated Dose (MTD) of Celebrex (celecoxib)

  12 week treatment; Continuous assessment and determination of dose-limiting toxicities.

Study Arms (1)

CPT-11 + Celecoxib/Cisplatin with RT

EXPERIMENTAL

CPT-11 + Celecoxib + Cisplatin + Radiation Therapy (RT)

Drug: Celecoxib; Drug: Cisplatin; Drug: CPT-11; Radiation: Concurrent Thoracic Radiation Therapy

Interventions

Celecoxib DRUG

100 mg by mouth (PO) twice daily for 5 days before beginning radiation therapy; continued 7 days per week throughout radiation treatment (about 7 weeks).

Also known as: Celebrex, SC-58635

CPT-11 + Celecoxib/Cisplatin with RT

Cisplatin DRUG

25 mg/m\^2 IV over 60 minutes on Day 1, Weeks 2-8

Also known as: Platinol-AQ, Platinol, CDDP

CPT-11 + Celecoxib/Cisplatin with RT

CPT-11 DRUG

30 mg/m\^2 IV over 90 minutes on Day 1, Weeks 2-8, followed by cisplatin which will be infused for 60 minutes.

Also known as: Irinotecan

CPT-11 + Celecoxib/Cisplatin with RT

Concurrent Thoracic Radiation Therapy RADIATION

63 Gy at 1.8 Gy/Fx in 35 Fractions over 7 weeks starting 2nd week of celebrex.

Also known as: XRT, RT

CPT-11 + Celecoxib/Cisplatin with RT

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• No history of active gastric ulcer, active GI bleeding, or renal failure.
• Patient must have histological or cytological evidence of NSCLC.
• Nonresectable Stage II or III NSCLC. Inoperable based on patient's physical status is acceptable.
• KPS is greater than or equal to 70.
• Age is greater than or equal to 18 or less than or equal to 80.
• Patient not receiving irradiation therapy or combined modality therapy to treat another malignancy.
• No evidence of distant metastatic disease.
• ANC count (segs \& bands) is greater than or equal to 2000/mm3 and platelet count is greater than or equal to 100,000/mm3.
• Serum creatinine less than or equal to 1.5 mg/dL.
• Total bilirubin is less than or equal to 1.5 times the institutional upper limits of normal value, SGOT less than or equal to 1.5 times the the institutional upper limit of normal.
• Patients may not be entered on investigational therapeutic trials.
• Patients or guardian must be informed of and understand the investigational nature of this study and give written informed consent prior to any study procedures.
• Patient may have prior chemotherapy. Chemotherapy must have been completed 4 weeks prior to study entry.
• Patients taking cardio-protective dose of aspirin 81 mg are allowed.

You may not qualify if:

• History of poorly controlled hypertension (systolic \>150 mm Hg), angina, or other cardiac abnormalities or history of MI or CHF in the last 6 months.
• General medical or psychological conditions which would not permit the patient to complete the study or sign the informed consent.
• Pregnancy or women of child bearing potential who do not use an effective (for them) method of birth control throughout their participation in this study.
• Patients who are currently receiving or have received amifostine for radioprotection within the prior six months are excluded.
• Patient with history of malignancy other than skin cancer or Carcinoma in-situ within 2 years.
• Patients who are allergic to Sulfonamides, NSAIDS or Celebrex will be excluded from this protocol.
• Patients who use routine NSAIDS such as high dose daily use of Aspirin higher than 2 Gm per day will be excluded. Patients will be allowed to take low dose aspirin (less than 200 mg per day).
• History of cardiovascular diseases that might include one of the following: myocardial infraction, angina, coronary angioplasty, congestive heart failure, stroke, or coronary bypass surgery in the last 6 months.
• Family history of premature coronary disease (i.e. - onset \< 55 years of age).
• Uncontrolled hypercholesteremia \[low-density lipoprotein cholesterol (LDL-C) \> 200\] more than twice in the repeated tests. Hypercholesteremia needs to be controlled following the updated National Cholesterol Education Program Adult Treatment Panel III Guidelines for at least 3 months prior to enrollment on the study. Hypercholesteremia treatment should continue during the entire period of Celecoxib treatment on the protocol
• History of deep venous thrombosis, pulmonary embolism, systemic lupus erythematous, family history of protein S or C deficiencies, prior heparin-induced thrombocytopenia, Factor V Leiden deficiencies or high homocysteine levels.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• National Comprehensive Cancer Network: collaborator

Study Sites (1)

UT MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• MD Anderson Cancer Center

MeSH Terms

Conditions

Lung Neoplasms; Carcinoma, Non-Small-Cell Lung

Interventions

Celecoxib; Cisplatin; Irinotecan

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms

Intervention Hierarchy (Ancestors)

Benzenesulfonamides; Sulfonamides; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Camptothecin; Alkaloids

Study Officials

• Ritsuko R Komaki, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 28, 2006
• First Posted: June 30, 2006
• Study Start: September 1, 2003
• Primary Completion: October 1, 2012
• Last Updated: October 22, 2012

Record last verified: 2012-10

Locations

US (1)