Carboplatin, Gemcitabine, and Thalidomide in Patients Undergoing Surgery for Stage II or III Non-Small Cell Lung Cancer - Full Text View

Purpose

RATIONALE: Drugs used in chemotherapy, such as carboplatin and gemcitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Thalidomide may stop the growth of tumor cells by blocking blood flow to the tumor. Giving carboplatin and gemcitabine together with thalidomide before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.

PURPOSE: This phase II trial is studying how well giving carboplatin and gemcitabine together with thalidomide works in treating patients who are undergoing surgery for stage II or stage III non-small cell lung cancer.

Condition	Intervention	Phase
Lung Cancer	Drug: carboplatin Drug: gemcitabine hydrochloride Drug: thalidomide Procedure: conventional surgery	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Phase II Trial of Neoadjuvant Therapy With Carboplatin and Gemcitabine With Thalidomide in Patients With Stage II and IIIA Non-Small Cell Lung Cancer

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lung Cancer

Drug Information available for: Thalidomide Carboplatin Gemcitabine Gemcitabine hydrochloride

U.S. FDA Resources

Further study details as provided by Masonic Cancer Center, University of Minnesota:

Primary Outcome Measures:

Number of Patients Reporting Clinical Response [ Time Frame: At end of 3 -21 day cycles of treatment ] [ Designated as safety issue: No ]
Objective clinical response measuring using tumor assessments: Complete Response (CR) = disappearance of all target and non-target lesions and normalization of tumor marker level, if applicable. Pathological Complete Response (PCR) = No viable tumor cells in specimen determined by light microscopy. Partial Response (PR) = at least 30% decrease in the sum of longest diameter of target lesions from baseline. Progressive Disease (PD) = at least 20% increase in the sum of longest diameters of target lesions from baseline or new lesions. Stable Disease (SD) = Neither PR or PD.

Secondary Outcome Measures:

Number of Patients Disease-free at 1 Year [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Calculated from date of enrollment to date of recurrence or death, whichever came first
Number of Patients Disease-free at 2 Years [ Time Frame: 2 Years ] [ Designated as safety issue: No ]
Calculated from date of enrollment to date of recurrence or death, whichever came first
Number of Patients Alive at 1 Year (Survival) [ Time Frame: 12 Months ] [ Designated as safety issue: Yes ]
Participants who were alive at one year from date of enrollment .
Number of Patients Alive at 2 Years (Survival) [ Time Frame: 24 Months ] [ Designated as safety issue: Yes ]
Participants who were alive at 2 years from date of enrollment.
Number of Patients Alive at 56 Months (End of Study) [ Time Frame: Up to 56 months ] [ Designated as safety issue: Yes ]
Patients alive from date of enrollment to date of death or censored at date of last contact (Overall Survival).

Enrollment:	22
Study Start Date:	May 2002
Study Completion Date:	July 2008
Primary Completion Date:	March 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Treatment Arm Chemotherapy treatment (carboplatin, gemcitabine and thalidomide) every 21 days for 3 courses.	Drug: carboplatin Day 1 of Cycles 1, 2 and 3 - intravenously (IV) 30 minutes (Area Under the Curve = 5.5) Other Name: PARAPLATIN Drug: gemcitabine hydrochloride Days 1 and 8 of Cycles 1, 2 and 3 - 30 minute IV, 1000 mg/m2. Other Name: Gemzar Drug: thalidomide Oral administration: Cycle 1 - Day 1 50 mg, Day 2 100 mg, Day 3 150 mg, Day 4 and continuing until end of study treatment 200 mg. Other Name: Thalidomid Procedure: conventional surgery Resection - between 2 and 6 weeks following last dose of chemotherapy. Other Names: Surgery Resection

Arms

Assigned Interventions

Experimental: Treatment Arm

Chemotherapy treatment (carboplatin, gemcitabine and thalidomide) every 21 days for 3 courses.

Drug: carboplatin

Day 1 of Cycles 1, 2 and 3 - intravenously (IV) 30 minutes (Area Under the Curve = 5.5)

Other Name: PARAPLATIN

Drug: gemcitabine hydrochloride

Days 1 and 8 of Cycles 1, 2 and 3 - 30 minute IV, 1000 mg/m2.

Other Name: Gemzar

Drug: thalidomide

Oral administration: Cycle 1 - Day 1 50 mg, Day 2 100 mg, Day 3 150 mg, Day 4 and continuing until end of study treatment 200 mg.

Other Name: Thalidomid

Procedure: conventional surgery

Resection - between 2 and 6 weeks following last dose of chemotherapy.

Other Names:

Surgery
Resection

Detailed Description:

OBJECTIVES:

Primary

Determine the complete and partial response rates in patients with stage II or IIIA non-small cell lung cancer treated with neoadjuvant carboplatin, gemcitabine hydrochloride, and thalidomide.

Secondary

Determine, preliminarily, the mechanism of action and activity of thalidomide against lung cancer.
Determine the 1-year and 2-year survival of patients treated with this regimen.
Determine the toxicity of this regimen in these patients.
Determine the operative mortality of patients treated with this regimen.

OUTLINE: This is a pilot study.

Patients receive carboplatin intravenously (IV) over 30 minutes on day 1, gemcitabine hydrochloride IV over 30 minutes on days 1 and 8, and oral thalidomide once daily on days 1-21. Treatment repeats every 21 days for 3 courses in the absence of disease progression or unacceptable toxicity. Within 2-6 weeks after the completion of chemotherapy, patients with resectable tumors undergo surgical resection.

After completion of study treatment, patients are followed every 3 months for 2 years.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Histologically or cytologically confirmed non-small cell lung cancer (NSCLC), including any of the following histologic subtypes:
- Squamous cell carcinoma
- Adenocarcinoma
- Large cell undifferentiated carcinoma
Stage II or IIIA disease
Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR ≥ 10 mm by spiral Computerized Axial Tomography (CT) scan
No tumor involving the superior sulcus (e.g., Pancoast tumor)
Karnofsky performance status 70-100%
Absolute neutrophil count ≥ 1,500/mm^3
Platelet count ≥ 100,000/mm^3
Creatinine ≤ 2 mg/dL
Bilirubin < 2 mg/dL
Aspartate aminotransferase (AST) < 3 times upper limit of normal

Exclusion Criteria:

Pregnant or nursing
- No nursing during and for ≥ 4 weeks after completion of study treatment
Positive pregnancy test
Fertile female patients must use 2 effective methods of contraception 4 weeks before, during, and for 4 weeks after completion of study treatment
Fertile male patients must use effective barrier contraception during and for 4 weeks after completion of study treatment
Blood, sperm, or ova donation during study treatment
Post obstructive pneumonia
Other serious infection or medical illness that would preclude study participation
Other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or other malignancy that is unlikely to affect survival for the next 3 years
Less than 5 years since prior resection of lung disease
Prior systemic chemotherapy or radiotherapy for non-small cell lung cancer (NSCLC)
Other concurrent chemotherapy or radiotherapy
Concurrent hormonal therapy or immunotherapy
Other concurrent anticancer therapy
Other concurrent investigational agents
Concurrent participation in another clinical study

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00281827

Locations

United States, Minnesota
University of Minnesota Cancer Center
Minneapolis, Minnesota, United States, 55455
Hubert H. Humphrey Cancer Center at North Memorial Outpatient Center
Robbinsdale, Minnesota, United States, 55422-2900
United States, New Hampshire
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756-0002

Sponsors and Collaborators

Masonic Cancer Center, University of Minnesota

Investigators

Study Chair:

Arkadiusz Dudek, MD

Masonic Cancer Center, University of Minnesota

More Information

No publications provided

Responsible Party:	Masonic Cancer Center, University of Minnesota
ClinicalTrials.gov Identifier:	NCT00281827 History of Changes
Other Study ID Numbers:	2002LS013, LILLY-X-382, 0202M17981
Study First Received:	January 24, 2006
Results First Received:	June 23, 2009
Last Updated:	November 6, 2012
Health Authority:	United States: Food and Drug Administration

Keywords provided by Masonic Cancer Center, University of Minnesota:

adenocarcinoma of the lung
squamous cell lung cancer
large cell lung cancer
stage II non-small cell lung cancer
stage IIIA non-small cell lung cancer

Additional relevant MeSH terms:

Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Thalidomide
Gemcitabine
Carboplatin
Immunosuppressive Agents
Immunologic Factors

Physiological Effects of Drugs
Pharmacologic Actions
Leprostatic Agents
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antiviral Agents

ClinicalTrials.gov processed this record on May 22, 2013