Clinical trial NCT00280735: Ph II Adjuvant Carboplatin/Docetaxel in Curatively Resected Stage I-IIIA NSCLC
Official title: Phase II Trial Exploring the Feasibility of Adjuvant Carboplatin/Docetaxel in Curatively Resected Stage I-IIIA Non-Small Cell Lung Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Lung Cancer
Keywords: stage I non-small cell lung cancer
stage II non-small cell lung cancer
stage IIIA non-small cell lung cancer
Lead sponsor: UNC Lineberger Comprehensive Cancer Center
Sponsor class: OTHER
Collaborators: name: Aventis Pharmaceuticals
First posted: 2006-01-23
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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

Exclusion criteria:

* Patients with a history of severe hypersensitivity to docetaxel or polysorbate 80 are excluded.
* Women who are currently or planning to breast feed.
* Those with peripheral neuropathy ≥ grade 2

PRIOR CONCURRENT THERAPY:

* 2-8 weeks since prior surgery and recovered

Primary outcomes:
measure: Number of Participants Who Completed Four Cycles of the Carboplatin/Docetaxel Regimen
timeFrame: 12 weeks from initiating adjuvant therapy
Secondary outcomes:
measure: Patterns of Recurrence in Patients Treated With This Regimen
timeFrame: Up to 5 years
measure: Toxicity in Patients Treated With This Regimen
timeFrame: Day 1 of treatment to 30 days after treatment discontinuation
measure: Progression Free Survival
timeFrame: The time between the start of treatment to disease progression or death or the date of last contact, measured up to 18 months
measure: Overall Survival
timeFrame: The time between the start of treatment to disease progression or death or the date of last contact, measured up to 18 months
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: University of North Carolina Lineberger Comprehensive Cancer Center
state: North Carolina
Study officials:
affiliation: Florida Hospital Cancer Institute
name: Mark A. Socinski, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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(2):145-51. doi: 10.1097/JTO.0b013e318160c5f1.