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Docetaxel and Cisplatin in Treating Patients With Stage I, Stage II, or Stage III Non-Small Cell Lung Cancer That Has Been Completely Removed By Surgery

Primary Purpose

Lung Cancer

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
cisplatin
docetaxel
adjuvant therapy
Sponsored by
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lung Cancer focused on measuring stage I non-small cell lung cancer, stage II non-small cell lung cancer, stage IIIA non-small cell lung cancer, stage IIIB non-small cell lung cancer

Eligibility Criteria

18 Years - 120 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
  • Memorial Sloan-Kettering Cancer Center
  • Vanderbilt-Ingram Cancer Center

Outcomes

Primary Outcome Measures

Total cisplatin dose

Secondary Outcome Measures

Toxicity
Overall survival
Disease-free survival

Full Information

First Posted
January 24, 2006
Last Updated
January 15, 2019
Sponsor
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00281970
Brief Title
Docetaxel and Cisplatin in Treating Patients With Stage I, Stage II, or Stage III Non-Small Cell Lung Cancer That Has Been Completely Removed By Surgery
Official Title
Phase II Trial of Weekly Docetaxel (Taxotere®) and Monthly Cisplatin Chemotherapy as Adjuvant Treatment for Patients With Completely Resected Non-small Cell Lung Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
August 2004 (undefined)
Primary Completion Date
June 2007 (Actual)
Study Completion Date
June 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Collaborators
National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.
Detailed Description
OBJECTIVES: Primary Compare the efficacy and safety of a new dosing schedule and dosing level of docetaxel and cisplatin with the chemotherapy regimens used in the International Adjuvant Lung Cancer Trial (IALT) in patients with completely resected stage IA-IIIB non-small cell lung cancer. Secondary Explore the relationship of time to recurrence, disease-free survival, and overall survival of these patients with levels of circulating DNA and proteomic analysis of serum. OUTLINE: This is an open-label study. Patients receive docetaxel IV over 30 minutes on days 1, 8, and 15 and cisplatin IV over 8 hours on day 15. Treatment repeats every 28 days for up to 4 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed periodically. PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer
Keywords
stage I non-small cell lung cancer, stage II non-small cell lung cancer, stage IIIA non-small cell lung cancer, stage IIIB non-small cell lung cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Masking
None (Open Label)
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
cisplatin
Intervention Type
Drug
Intervention Name(s)
docetaxel
Intervention Type
Procedure
Intervention Name(s)
adjuvant therapy
Primary Outcome Measure Information:
Title
Total cisplatin dose
Secondary Outcome Measure Information:
Title
Toxicity
Title
Overall survival
Title
Disease-free survival

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Charles M. Rudin, MD, PhD
Organizational Affiliation
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21231-2410
Country
United States
Facility Name
Memorial Sloan-Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Vanderbilt-Ingram Cancer Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232-6307
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
17607120
Citation
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.
Results Reference
result

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Docetaxel and Cisplatin in Treating Patients With Stage I, Stage II, or Stage III Non-Small Cell Lung Cancer That Has Been Completely Removed By Surgery

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