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

Study Description

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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.

Condition or disease	Intervention/treatment	Phase
Lung Cancer	Drug: carboplatin; Drug: docetaxel	Phase 2

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.

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	75 participants
Intervention Model:	Single Group Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	Phase II Trial Exploring the Feasibility of Adjuvant Carboplatin/Docetaxel in Curatively Resected Stage I-IIIA Non-Small Cell Lung Cancer
Actual Study Start Date :	May 2004
Actual Primary Completion Date :	July 2011
Actual Study Completion Date :	July 2011

Arms and Interventions

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Arm	Intervention/treatment
Single Arm Trial; adjuvant carboplatin plus docetaxel carboplatin area under curve (AUC) = 6 IV on day 1 every 3 weeks for 4 cycles docetaxel 75 mg/m² IV on day 1 every 3 weeks for 4 cycles	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); Other Name: paraplatin Drug: docetaxel; 75 mg/m² intravenously, once, every 3 weeks; Other Name: Taxotere

Outcome Measures

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Primary Outcome Measures :

1. Number of Participants Who Completed Four Cycles of the Carboplatin/Docetaxel Regimen [ Time Frame: 12 weeks from initiating adjuvant therapy ]
   Feasibility was based on the percentage of patients completing four cycles of the carboplatin/docetaxel regimen to a high fraction of patients with curatively resected stage IIIIA non-small cell lung cancer within 12 weeks.

Secondary Outcome Measures :

1. Patterns of Recurrence in Patients Treated With This Regimen [ Time Frame: Up to 5 years ]
   Patterns were assessed with a staging chest computerized tomography (CT), bone or positron emission tomography (PET) scan and brain magnetic resonance imaging (MRI)/CT scan at recurrence.
2. Toxicity in Patients Treated With This Regimen [ Time Frame: Day 1 of treatment to 30 days after treatment discontinuation ]
   Safety determinations are based on the rate of drug-related adverse events (AEs) reported based upon the toxicity as measured by the NCI Common Terminology Criteria for Adverse Events version 3.0 (CTCAE v3.0).
3. Progression Free Survival [ Time Frame: The time between the start of treatment to disease progression or death or the date of last contact, measured up to 18 months ]
   Relapse-free survival rate at 18 months. Patients were determined to have progression either by radiographic and/or pathological assessment by local physician per local standard of care monitoring for disease recurrence.
4. Overall Survival [ Time Frame: The time between the start of treatment to disease progression or death or the date of last contact, measured up to 18 months ]
   Overall survival rate at 18 months.

Eligibility Criteria

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Ages Eligible for Study:	18 Years to 120 Years (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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

Contacts and Locations

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Locations

United States, North Carolina
University of North Carolina Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, United States, 27599

Sponsors and Collaborators

UNC Lineberger Comprehensive Cancer Center

Aventis Pharmaceuticals

Investigators

Principal Investigator:	Mark A. Socinski, MD	Florida Hospital Cancer Institute

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:

UNC Lineberger Comprehensive Cancer Center 

Publications of Results:

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.

Responsible Party:	UNC Lineberger Comprehensive Cancer Center
ClinicalTrials.gov Identifier:	NCT00280735 History of Changes
Other Study ID Numbers:	LCCC 0320
First Posted:	January 23, 2006
Results First Posted:	June 12, 2017
Last Update Posted:	July 11, 2017
Last Verified:	June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	No

Keywords provided by UNC Lineberger Comprehensive Cancer Center:

stage I non-small cell lung cancer; stage II non-small cell lung cancer; stage IIIA non-small cell lung cancer

Additional relevant MeSH terms:

Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carcinoma, Bronchogenic	Bronchial Neoplasms; Docetaxel; Carboplatin; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Molecular Mechanisms of Pharmacological Action