NCT00281970

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as docetaxel and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving chemotherapy drugs after surgery may kill any tumor cells that remain after surgery. PURPOSE: This phase II trial is studying how well giving docetaxel together with cisplatin works in treating patients with stage I, stage II, or stage III non-small cell lung cancer that has been completely removed by surgery.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P50-P75 for phase_2 lung-cancer

Timeline
Completed

Started Aug 2004

Typical duration for phase_2 lung-cancer

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2004

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

January 24, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 25, 2006

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2007

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2009

Completed
Last Updated

January 17, 2019

Status Verified

October 1, 2016

Enrollment Period

2.8 years

First QC Date

January 24, 2006

Last Update Submit

January 15, 2019

Conditions

Lung Cancer

Keywords

stage I non-small cell lung cancerstage II non-small cell lung cancerstage IIIA non-small cell lung cancerstage IIIB non-small cell lung cancer

Outcome Measures

Primary Outcomes (1)

  • Total cisplatin dose

Secondary Outcomes (3)

  • Toxicity

  • Overall survival

  • Disease-free survival

Interventions

cisplatinDRUG
docetaxelDRUG
adjuvant therapyPROCEDURE

Eligibility Criteria

Age18 Years - 120 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Pathologically proven non-small cell lung cancer (NSCLC) * Stage IA-IIIB disease * Underwent prior complete surgical resection (R0) no more than 2 months ago * Eligible for cisplatin-based adjuvant chemotherapy PATIENT CHARACTERISTICS: * Karnofsky performance status ≥ 70% * Absolute neutrophil count ≥ 1,500/mm\^3 * Hemoglobin ≥ 8.0 g/dL * Platelet count ≥ 100,000/mm\^3 * Creatinine clearance \> 55 mL/min * Total bilirubin normal * Alkaline phosphatase, AST, and ALT must meet 1 of the following criteria: * Alkaline phosphatase (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 * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception during and for 3 months after completion of study treatment * No history of severe hypersensitivity reaction to docetaxel or other drugs formulated with polysorbate 80 * No peripheral neuropathy \> grade 1 * No hearing deficit at baseline, even if it does not require a hearing aid or intervention or interfere with activities of daily life (i.e., CTCAE grade 2 or higher) PRIOR CONCURRENT THERAPY: * See Disease Characteristics * No prior postoperative radiation therapy * No prior chemotherapy for NSCLC * No prior docetaxel or cisplatin * No concurrent prophylactic filgrastim (G-CSF) or pegfilgrastim

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (3)

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Baltimore, Maryland, 21231-2410, United States

Location

Memorial Sloan-Kettering Cancer Center

New York, New York, 10021, United States

Location

Vanderbilt-Ingram Cancer Center

Nashville, Tennessee, 37232-6307, United States

Location

Related Publications (1)

  • Azzoli CG, Krug LM, Miller VA, Rizvi NA, Kris MG, Dunne M, Farmer A, Pizzo B, Tyson L, Seeger T, Coleman B, Moore E, Lastinger L, Venkatraman E, Rudin CM. A phase II tolerability study of cisplatin plus docetaxel as adjuvant chemotherapy for resected non-small cell lung cancer. J Thorac Oncol. 2007 Jul;2(7):638-44. doi: 10.1097/JTO.0b013e318074bbd0.

    PMID: 17607120RESULT

MeSH Terms

Conditions

Lung NeoplasmsCarcinoma, Non-Small-Cell Lung

Interventions

CisplatinDocetaxelChemotherapy, Adjuvant

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract DiseasesCarcinoma, BronchogenicBronchial Neoplasms

Intervention Hierarchy (Ancestors)

Chlorine CompoundsInorganic ChemicalsNitrogen CompoundsPlatinum CompoundsTaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenesCombined Modality TherapyTherapeuticsDrug Therapy

Study Officials

  • Charles M. Rudin, MD, PhD

    Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Masking
NONE
Purpose
TREATMENT
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 24, 2006

First Posted

January 25, 2006

Study Start

August 1, 2004

Primary Completion

June 1, 2007

Study Completion

June 1, 2009

Last Updated

January 17, 2019

Record last verified: 2016-10

Locations

US(3)