Ph II Adjuvant Carboplatin/Docetaxel in Curatively Resected Stage I-IIIA NSCLC

Lung Cancer Clinical Trial

Official title:

Phase II Trial Exploring the Feasibility of Adjuvant Carboplatin/Docetaxel in Curatively Resected Stage I-IIIA Non-Small Cell Lung Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00280735
• Other study ID #: LCCC 0320
• Status: Completed
• Phase: Phase 2
• First received: January 19, 2006
• Last updated: February 24, 2017
• Start date: May 2004
• Est. completion date: July 2011

Study information

• Verified date: February 2017
• Source: UNC Lineberger Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

RATIONALE: Drugs used in chemotherapy, such as carboplatin and docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving carboplatin together with docetaxel after surgery may kill any tumor cells that remain after surgery.

PURPOSE: This phase II trial is studying how well giving carboplatin together with docetaxel works in treating patients with stage I, stage II, or stage III non-small cell lung cancer.

Description:

OBJECTIVES:

Primary

• Evaluate the feasibility of adjuvant carboplatin and docetaxel in patients with resected stage I, II, or IIIA non-small cell lung cancer.

Secondary

• Determine the toxicity of this regimen in these patients.

• Determine the survival patterns of patients treated with this regimen.

• Assess the patterns of recurrence in patients treated with this regimen.

OUTLINE: Patients receive carboplatin IV on day 1 and docetaxel IV on day 1. Treatment repeats every 3 weeks for 4 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed every 3 months for 2 years and then every 6 months for 3 years.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: July 2011
• Est. primary completion date: July 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 120 Years

Eligibility

DISEASE CHARACTERISTICS:

Inclusion criteria:

• Histologically confirmed non-small cell lung cancer

• Stage I-IIIA disease

• Must have undergone a complete resection

• Must begin adjuvant chemotherapy within 8 weeks of surgical resection

PATIENT CHARACTERISTICS:

• Eastern Cooperative Oncology Group (ECOG) performance status 0-1

• Absolute neutrophil count = 1,500/mm^3

• Hemoglobin = 8.0 g/dL

• Platelet count = 100,000/mm^3

• Serum creatinine normal OR creatinine clearance = 40 mL/min

• Bilirubin normal

• Alkaline phosphatase (AP), Aspartate aminotransferase (AST), and Alanine transaminase (ALT) must meet 1 of the following criteria:

• AP normal AND AST and ALT = 5 times upper limit of normal (ULN)

• AP = 2.5 times ULN AND AST and ALT = 1.5 times ULN

• AP = 5 times ULN AND AST and ALT normal

• Negative pregnancy test

• Fertile patients must use effective contraception during and for at least 3 months after study therapy

• No breastfeeding

• No peripheral neuropathy = grade 2

• No history of severe hypersensitivity to docetaxel or polysorbate 80

• Prior history of malignancy allowed provided the attending medical oncologists believes that adjuvant chemotherapy is indicated and will potentially benefit the patient

PRIOR CONCURRENT THERAPY:

• 2-8 weeks since prior surgery and recovered

Related Conditions & MeSH terms

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

Intervention

Drug:
• carboplatin
Carboplatin will be given intravenously,once,every 3 weeks. The carboplatin area under curve (AUC) dose will be calculated using the Calvert Equation 19 as follows: Carboplatin dose (mg) = 6x (GFR + 25)
• docetaxel
75 mg/m² intravenously, once, every 3 weeks

Locations

Country	Name	City	State
United States	University of North Carolina Lineberger Comprehensive Cancer Center	Chapel Hill	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
UNC Lineberger Comprehensive Cancer Center	Aventis Pharmaceuticals

Country where clinical trial is conducted

United States, 

References & Publications (1)

Stinchcombe TE, Harper HD, Hensing TA, Moore DT, Crane JM, Atkins JN, Willard EM, Detterbeck FC, Socinski MA. The feasibility of adjuvant carboplatin and docetaxel in patients with curatively resected non-small cell lung cancer. J Thorac Oncol. 2008 Feb;3 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility of administering of carboplatin/docetaxel as adjuvant therapy in resected stage I-IIIA NSCLC		12 weeks
Secondary	Number of subjects with toxicity	Assess the number of subjects experiencing toxicities(per the CTCAE criteria) after receiving carboplatin/docetaxel in the adjuvant setting	12 weeks