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CompletedPhase 2NCT00280735
Official study title

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

Study 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.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedcarboplatin and docetaxel

The study team can explain what participation involves.

Who it may be forNon-small cell lung cancer (NSCLC) · Early-stage or resectable · Locally advanced

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Jul 11, 2017 · Source: ClinicalTrials.gov

Is enrollment open?Completed

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 2

Interventional

Where is it offered?1 U.S. location

Locations may change over time.

Who runs it?UNC Lineberger Comprehensive Cancer Center

Study sponsor

01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 2
Sponsor
UNC Lineberger Comprehensive Cancer Center
Interventions being studied
Drug: carboplatin; Drug: docetaxel
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

Cancer type
Non-small cell lung cancer (NSCLC)→
Disease setting
Early-stage or resectable→Locally advanced→
Treatment approach
Chemotherapy→Surgery→
Study topics
After surgery (adjuvant)→
03
Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion criteria
  • DISEASE CHARACTERISTICS:
  • 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
Reasons someone may not be able to joinExclusion 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

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • University of North Carolina Lineberger Comprehensive Cancer CenterChapel Hill, North Carolina

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Jul 11, 2017. Always confirm current availability with the study team.

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