Chemotherapy Plus Radiation Therapy in Treating Patients With Stage III Non-small Cell Lung Cancer That Cannot Be Surgically Removed

NCT00004160 | Completed Phase 1 DMC

• 4 other identifiers: CDR0000067400UAB-9718UAB-F97073005NCI-G99-1625
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining chemotherapy with radiation therapy may kill more tumor cells. PURPOSE: Phase I/II trial to study the effectiveness of chemotherapy plus radiation therapy in treating patients who have stage III non-small cell lung cancer that cannot be surgically removed.

Conditions

Lung Cancer

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Determine the maximum tolerated dose and dose limiting toxicity of gemcitabine and paclitaxel in combination with radiotherapy in patients with locally advanced stage IIIA or IIIB non-small cell lung cancer.

  baseline to 6 - 11 weeks

Secondary Outcomes (2)

• Assess response rate, duration of response, disease free survival and failure in this patient population on this regimen.

  baseline to 6 - 11 weeks

• Determine the pharmacokinetics of gemcitabine and paclitaxel during the chemoradiotherapy phase

  baseline to 6 - 11 weeks

Study Arms (5)

Dose 1 Gemcitabine

EXPERIMENTAL

Patients receive paclitaxel IV over 1 hour and gemcitabine IV over 30 minutes beginning 2 hours into paclitaxel infusion on day 1 of weeks 6, 9, and 12.

Drug: cisplatin; Drug: gemcitabine hydrochloride; Drug: paclitaxel; Radiation: radiation therapy

Dose 2 Gemcitabine

EXPERIMENTAL

Patients receive paclitaxel IV over 1 hour and gemcitabine IV over 30 minutes beginning 2 hours into paclitaxel infusion on day 1 of weeks 6, 9, and 12.

Drug: cisplatin; Drug: gemcitabine hydrochloride; Drug: paclitaxel; Radiation: radiation therapy

Dose 3 Gemcitabine

EXPERIMENTAL

Patients receive paclitaxel IV over 1 hour and gemcitabine IV over 30 minutes beginning 2 hours into paclitaxel infusion on day 1 of weeks 6, 9, and 12.

Drug: cisplatin; Drug: gemcitabine hydrochloride; Drug: paclitaxel; Radiation: radiation therapy

Dose 4 Gemcitabine

EXPERIMENTAL

Patients receive paclitaxel IV over 1 hour and gemcitabine IV over 30 minutes beginning 2 hours into paclitaxel infusion on day 1 of weeks 6, 9, and 12.

Drug: cisplatin; Drug: gemcitabine hydrochloride; Drug: paclitaxel; Radiation: radiation therapy

Dose 5 Gemcitabine

EXPERIMENTAL

Patients receive paclitaxel IV over 1 hour and gemcitabine IV over 30 minutes beginning 2 hours into paclitaxel infusion on day 1 of weeks 6, 9, and 12.

Drug: cisplatin; Drug: gemcitabine hydrochloride; Drug: paclitaxel; Radiation: radiation therapy

Interventions

cisplatin DRUG

Dose 1 Gemcitabine; Dose 2 Gemcitabine; Dose 3 Gemcitabine; Dose 4 Gemcitabine; Dose 5 Gemcitabine

gemcitabine hydrochloride DRUG

Dose 1 Gemcitabine; Dose 2 Gemcitabine; Dose 3 Gemcitabine; Dose 4 Gemcitabine; Dose 5 Gemcitabine

paclitaxel DRUG

Dose 1 Gemcitabine; Dose 2 Gemcitabine; Dose 3 Gemcitabine; Dose 4 Gemcitabine; Dose 5 Gemcitabine

radiation therapy RADIATION

Dose 1 Gemcitabine; Dose 2 Gemcitabine; Dose 3 Gemcitabine; Dose 4 Gemcitabine; Dose 5 Gemcitabine

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: Histologically or cytologically confirmed locally advanced, unresectable non- small cell lung cancer Stage IIIA or IIIB Local, unresectable recurrence after primary surgery allowed Measurable or evaluable disease No contralateral pleural effusion(s) or noncontiguous pleural implants T4 tumors with small ipsilateral pleural effusions allowed PATIENT CHARACTERISTICS: Age: Not specified Performance status: ECOG 0-2 Life expectancy: Not specified Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hemoglobin at least 10 g/dL Hepatic: Bilirubin no greater than 1.5 mg/dL SGOT or SGPT no greater than 2 times upper limit of normal Renal: Creatinine no greater than 1.5 mg/dL OR Creatinine clearance at least 60 mL/min Cardiovascular: No prior myocardial infarction within the past 6 months No congestive heart failure No uncontrolled arrhythmias Pulmonary: FEV1 greater than 800 mL Other: Not pregnant Negative pregnancy test Fertile patients must use effective contraception No history of hypersensitivity to drugs formulated in Cremophor EL No other malignancy within the past 5 years, except: Nonmelanomatous skin cancer Carcinoma in situ of the cervix No overt psychosis or other major debilitating disorder that would preclude compliance PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy Endocrine therapy: Not specified Radiotherapy: No prior radiotherapy Surgery: See Disease Characteristics

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

Sponsors & Collaborators

• University of Alabama at Birmingham: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

University of Alabama Comprehensive Cancer Center

Birmingham, Alabama, 35294, United States

Location

Related Publications (1)

• Divers SG, Spencer SA, Carey D, Busby EM, Hyatt MD, Robert F. Phase I/IIa study of cisplatin and gemcitabine as induction chemotherapy followed by concurrent chemoradiotherapy with gemcitabine and paclitaxel for locally advanced non-small-cell lung cancer. J Clin Oncol. 2005 Sep 20;23(27):6664-73. doi: 10.1200/JCO.2005.02.519.

  PMID: 16170174 RESULT

MeSH Terms

Conditions

Lung Neoplasms; Carcinoma, Non-Small-Cell Lung

Interventions

Cisplatin; Gemcitabine; Paclitaxel; 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; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Therapeutics

Study Officials

• Francisco Robert, MD, FACP

  University of Alabama at Birmingham

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 10, 1999
• First Posted: July 19, 2004
• Study Start: February 1, 2000
• Primary Completion: May 1, 2004
• Study Completion: May 1, 2004
• Last Updated: November 26, 2013

Record last verified: 2005-10

Locations

US (1)