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

NCT00281827 | Terminated Phase 2 Results DMC

• 3 other identifiers: 2002LS013LILLY-X-3820202M17981
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Lung Cancer

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Number of Patients Reporting Clinical Response

  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.

  At end of 3 -21 day cycles of treatment

Secondary Outcomes (5)

• Number of Patients Disease-free at 1 Year

  1 year

• Number of Patients Disease-free at 2 Years

  2 Years

• Number of Patients Alive at 1 Year (Survival)

  12 Months

• Number of Patients Alive at 2 Years (Survival)

  24 Months

• Number of Patients Alive at 56 Months (End of Study)

  Up to 56 months

Study Arms (1)

Treatment Arm

EXPERIMENTAL

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

Drug: carboplatin; Drug: gemcitabine hydrochloride; Drug: thalidomide; Procedure: conventional surgery

Interventions

carboplatin DRUG

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

Also known as: PARAPLATIN

Treatment Arm

gemcitabine hydrochloride DRUG

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

Also known as: Gemzar

Treatment Arm

thalidomide DRUG

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.

Also known as: Thalidomid

Treatment Arm

conventional surgery PROCEDURE

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

Also known as: Surgery, Resection

Treatment Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Masonic Cancer Center, University of Minnesota: lead

Study Sites (3)

University of Minnesota Cancer Center

Minneapolis, Minnesota, 55455, United States

Location

Hubert H. Humphrey Cancer Center at North Memorial Outpatient Center

Robbinsdale, Minnesota, 55422-2900, United States

Location

Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03756-0002, United States

Location

MeSH Terms

Conditions

Lung Neoplasms; Adenocarcinoma of Lung; Carcinoma, Non-Small-Cell Lung

Interventions

Carboplatin; Gemcitabine; Thalidomide; Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Carcinoma, Bronchogenic; Bronchial Neoplasms

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Phthalimides; Phthalic Acids; Acids, Carbocyclic; Carboxylic Acids; Piperidones; Piperidines; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Results Point of Contact

• Title: Arkadiusz Dudek, M.D.
• Organization: Masonic Cancer Center, University of Minnesota

dudek002@umn.edu

612-624-0123

Study Officials

• Arkadiusz Dudek, MD

  Masonic Cancer Center, University of Minnesota

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 24, 2006
• First Posted: January 25, 2006
• Study Start: May 1, 2002
• Primary Completion: March 1, 2008
• Study Completion: July 1, 2008
• Last Updated: December 28, 2017
• Results First Posted: December 3, 2009

Record last verified: 2017-12

Locations

US (3)