Surgery, Gemcitabine, Cisplatin, and Radiation Therapy in Treating Patients With Stage II or Stage III Non-Small Cell Lung Cancer

NCT00530634 | Terminated Phase 2 Results

• 4 other identifiers: 99077P30CA033572CHNMC-99077CDR0000564760
• Study Type: interventional
• Target: 3
• Locations: 0 countries
• Sites: N/A

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as gemcitabine 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 more than one drug (combination chemotherapy) together with radiation therapy after surgery may kill any tumor cells that remain after surgery. PURPOSE: This phase II trial is studying how well surgery followed by gemcitabine, cisplatin, and radiation therapy works in treating patients with stage II or stage III non-small cell lung cancer.

Conditions

Lung Cancer

Keywords

stage II non-small cell lung cancer; stage IIIA non-small cell lung cancer; stage IIIB non-small cell lung cancer

Outcome Measures

Primary Outcomes (1)

• Two-year Progression-free Survival From the Date of Surgery

  Estimated using the product-limit method of Kaplan and Meier. Progression defined as a 25% increase or an increase of 10 cm2 (whichever is smaller) in the sum of the products of all measurable lesions over the smallest sum observed (over baseline if no decrease) using the same techniques as baseline, or clear worsening of any evaluable disease, or reappearance of any lesion that had disappeared, or appearance of any new lesion/site, or failure to return for evaluation or death, or deteriorating condition (unless clearly unrelated to this cancer).

  2 years post-surgery

Study Arms (1)

Gemcitabine + Cisplatin

EXPERIMENTAL

Surgical resection followed by (within 60 days) by chemotherapy (Gemcitabine at 1000 mg/m2 IV over 30 minutes on days 1 and 8 of a 21 day cycle and Cisplatin at 75 mg/m2 IV over 1 hour on day 8 of a 21 day cycle) followed by radiation therapy (treated using linear accelerator with photon beam energy of 6-21 MV) upon completion of 3 cycles of chemotherapy.

Drug: cisplatin; Drug: gemcitabine hydrochloride; Genetic: gene expression analysis; Genetic: reverse transcriptase-polymerase chain reaction; Other: immunohistochemistry staining method; Procedure: adjuvant therapy; Procedure: conventional surgery; Radiation: radiation therapy

Interventions

cisplatin DRUG

Gemcitabine + Cisplatin

gemcitabine hydrochloride DRUG

Gemcitabine + Cisplatin

gene expression analysis GENETIC

Gemcitabine + Cisplatin

reverse transcriptase-polymerase chain reaction GENETIC

Gemcitabine + Cisplatin

immunohistochemistry staining method OTHER

Gemcitabine + Cisplatin

adjuvant therapy PROCEDURE

Gemcitabine + Cisplatin

conventional surgery PROCEDURE

Gemcitabine + Cisplatin

radiation therapy RADIATION

Gemcitabine + Cisplatin

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed single, primary bronchogenic non-small cell lung cancer meeting the following subtypes: * Adenocarcinoma (no bronchioalveolar cell histology) * Squamous cell carcinoma * Large cell carcinoma * Meeting the following staging criteria: * Stage IIB (T2, N1, M0, or T3, N0, M0) * Stage IIIA (T1-3, N2, M0 or T3, N1, M0) * Stage IIIB (Any T, N3, M0 or T4, Any N, M0) * No more than 1 parenchymal lesion in the same lung or in both lungs * No tumor involving the superior sulcus (e.g., Pancoast tumor) * Patients must undergo evaluation by the involved thoracic surgeon, medical oncologist, and radiation oncologist prior to registration * No evidence of metastatic disease * Biopsy or aspiration cytology required to confirm the benign diagnosis of CT or MRI abnormalities that potentially represent metastatic disease * Biopsy required if all noninvasive tests are indeterminant PATIENT CHARACTERISTICS: * Karnofsky performance status 70-100% * Absolute granulocyte count ≥ 1,500/μL * Platelet count ≥ 100,000/μL * Bilirubin ≤ 3 times upper limit of normal (ULN) * SGOT and SGPT ≤ 3 times ULN * Creatinine clearance \> 50 mL/min * No prior malignancy except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, ductal or lobular carcinoma in situ of the breast, or any other cancer from which the patient has been disease-free for 5 years * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective protection * No significant hearing loss or patient unwilling to accept potential for further hearing loss * No uncontrolled medical illness by appropriate medical therapy (e.g., myocardial infarction within the past 3 months or liver cirrhosis) * No symptomatic peripheral neuropathy affecting activities of daily living PRIOR CONCURRENT THERAPY: * No prior chemotherapy or radiotherapy for lung cancer

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

Sponsors & Collaborators

• City of Hope Medical Center: lead
• National Cancer Institute (NCI): collaborator

MeSH Terms

Conditions

Lung Neoplasms; Carcinoma, Non-Small-Cell Lung

Interventions

Cisplatin; Gemcitabine; Gene Expression Profiling; Reverse Transcriptase Polymerase Chain Reaction; Immunohistochemistry; Chemotherapy, Adjuvant; Radiotherapy

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Genetic Techniques; Investigative Techniques; Polymerase Chain Reaction; Nucleic Acid Amplification Techniques; Histocytochemistry; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Histological Techniques; Immunologic Techniques; Combined Modality Therapy; Therapeutics; Drug Therapy

Limitations and Caveats

Study was closed early due to poor accrual. Reported data are not statistically powered to provide meaningful conclusions

Results Point of Contact

• Title: Jeff Longmate, Ph.D.
• Organization: City of Hope

jlongmat@coh.org

626-256-4673

Study Officials

• Marianna Koczywas, MD

  City of Hope Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

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

Study Record Dates

• First Submitted: September 13, 2007
• First Posted: September 17, 2007
• Study Start: August 1, 1999
• Primary Completion: June 1, 2013
• Study Completion: June 1, 2013
• Last Updated: October 29, 2015
• Results First Posted: September 17, 2015

Record last verified: 2015-10