Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Non-Small Cell Lung Cancer

NCT00032032 | Completed Phase 1 DMC

• 3 other identifiers: NCCTG-N0028NCI-2012-02458CDR0000069250
• Study Type: interventional
• Target: 69
• Locations: 1 country
• Sites: 51

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 and radiation therapy may kill more tumor cells. PURPOSE: This phase I/II trial is studying the side effects and best dose of radiation therapy when given with combination chemotherapy and to see how well they work in treating patients with non-small cell lung cancer that cannot be surgically removed.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• Maximum tolerated dose (MTD) as assessed by dose-limiting toxicity within 1 month after completion of study treatment (phase I)

  Up to 1 month

• Survival at 2 years (phase II)

  Up to 2 years

Secondary Outcomes (4)

• Survival time

  Up to 5 years

• Toxicity

  Up to 5 years

• Time to progression

  Up to 5 years

• Time to local progression

  Up to 5 years

Study Arms (1)

radiotherapy + paclitaxel + carboplatin

EXPERIMENTAL

Patients undergo radiotherapy once daily 5 days a week for 7 weeks and 2 days (a total of 37 fractions). Patients concurrently receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes once weekly for 7 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity. Beginning 3 weeks after completion of radiotherapy, patients receive paclitaxel and carboplatin as above. Treatment repeats every 21 days for 3 courses in the absence of disease progression or unacceptable toxicity. Quality of life is assessed at baseline, once during the last week of radiotherapy, and then every 3 months for 2 years. Patients are followed at 3 weeks, every 3 months for 21 months, and then every 6 months for 3 years.

Drug: carboplatin; Drug: paclitaxel; Radiation: radiation therapy

Interventions

carboplatin DRUG

radiotherapy + paclitaxel + carboplatin

paclitaxel DRUG

radiotherapy + paclitaxel + carboplatin

radiation therapy RADIATION

radiotherapy + paclitaxel + carboplatin

Eligibility Criteria

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

DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed non-small cell lung cancer (NSCLC) * Stage I, II, or III NSCLC that is unresectable due to tumor extent or other medical reasons * Measurable disease * Tumor must not exceed volume that would require radiation volumes greater than those allowed on this study * No more than blunting of the costophrenic angle on chest x-ray due to pleural effusions * No more than small effusions seen on chest CT scan only * No supraclavicular adenopathy PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * ECOG 0-1 Life expectancy: * At least 12 weeks Hematopoietic: * Absolute neutrophil count at least 1,500/mm\^3 * Platelet count at least 100,000/mm\^3 Hepatic: * Total bilirubin no greater than 1.5 times upper limit of normal (ULN) OR * Direct bilirubin no greater than 1.5 times ULN * AST no greater than 3 times ULN Renal: * Creatinine clearance at least 40 mL/min Cardiovascular: * No New York Heart Association class III or IV heart disease Pulmonary: * FEV\_1 at least 1 L or 35% of predicted Other: * No grade 2 or greater peripheral neuropathy * No weight loss of 10% or more within the past 3 months * No uncontrolled infection * No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, adequately treated noninvasive carcinoma (carcinoma in situ), or localized prostate cancer * No other severe underlying disease that would preclude study participation * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic: * No prior biologic therapy for NSCLC * No concurrent biologic therapy * No concurrent prophylactic filgrastim (G-CSF) Chemotherapy: * No prior chemotherapy for NSCLC * No other concurrent chemotherapy Endocrine therapy: * No prior endocrine therapy for NSCLC Radiotherapy: * No prior radiotherapy for NSCLC Surgery: * No prior surgery for NSCLC

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

Sponsors & Collaborators

• Alliance for Clinical Trials in Oncology: lead
• National Cancer Institute (NCI): collaborator

Study Sites (51)

Mayo Clinic Scottsdale

Scottsdale, Arizona, 85259-5499, United States

Location

Mayo Clinic - Jacksonville

Jacksonville, Florida, 32224, United States

Location

McFarland Clinic, PC

Ames, Iowa, 50010, United States

Location

Mercy Capitol Hospital

Des Moines, Iowa, 50307, United States

Location

CCOP - Iowa Oncology Research Association

Des Moines, Iowa, 50309, United States

Location

John Stoddard Cancer Center at Iowa Methodist Medical Center

Des Moines, Iowa, 50309, United States

Location

Medical Oncology and Hematology Associates at John Stoddard Cancer Center

Des Moines, Iowa, 50309, United States

Location

Medical Oncology and Hematology Associates at Mercy Cancer Center

Des Moines, Iowa, 50314, United States

Location

Mercy Cancer Center at Mercy Medical Center - Des Moines

Des Moines, Iowa, 50314, United States

Location

John Stoddard Cancer Center at Iowa Lutheran Hospital

Des Moines, Iowa, 50316, United States

Location

Siouxland Hematology-Oncology Associates, LLP

Sioux City, Iowa, 51101, United States

Location

Mercy Medical Center - Sioux City

Sioux City, Iowa, 51104, United States

Location

St. Luke's Regional Medical Center

Sioux City, Iowa, 51104, United States

Location

Hickman Cancer Center at Bixby Medical Center

Adrian, Michigan, 49221, United States

Location

Haematology-Oncology Associates of Ohio and Michigan, PC

Lambertville, Michigan, 48144, United States

Location

Community Cancer Center of Monroe

Monroe, Michigan, 48162, United States

Location

Mercy Memorial Hospital - Monroe

Monroe, Michigan, 48162, United States

Location

MeritCare Bemidji

Bemidji, Minnesota, 56601, United States

Location

Mayo Clinic Cancer Center

Rochester, Minnesota, 55905, United States

Location

CCOP - Missouri Valley Cancer Consortium

Omaha, Nebraska, 68106, United States

Location

Immanuel Medical Center

Omaha, Nebraska, 68122, United States

Location

Alegant Health Cancer Center at Bergan Mercy Medical Center

Omaha, Nebraska, 68124, United States

Location

Creighton University Medical Center

Omaha, Nebraska, 68131-2197, United States

Location

Bismarck Cancer Center

Bismarck, North Dakota, 58501, United States

Location

Medcenter One Hospital Cancer Care Center

Bismarck, North Dakota, 58501, United States

Location

Mid Dakota Clinic, PC

Bismarck, North Dakota, 58501, United States

Location

St. Alexius Medical Center Cancer Center

Bismarck, North Dakota, 58502, United States

Location

CCOP - MeritCare Hospital

Fargo, North Dakota, 58122, United States

Location

MeritCare Broadway

Fargo, North Dakota, 58122, United States

Location

Wood County Oncology Center

Bowling Green, Ohio, 43402, United States

Location

Fremont Memorial Hospital

Fremont, Ohio, 43420, United States

Location

Lima Memorial Hospital

Lima, Ohio, 45804, United States

Location

Northwest Ohio Oncology Center

Maumee, Ohio, 43537, United States

Location

St. Luke's Hospital

Maumee, Ohio, 43537, United States

Location

St. Charles Mercy Hospital

Oregon, Ohio, 43616, United States

Location

Toledo Clinic - Oregon

Oregon, Ohio, 43616, United States

Location

Firelands Regional Medical Center

Sandusky, Ohio, 44870, United States

Location

North Coast Cancer Care, Incorporated

Sandusky, Ohio, 44870, United States

Location

Flower Hospital Cancer Center

Sylvania, Ohio, 43560, United States

Location

Mercy Hospital of Tiffin

Tiffin, Ohio, 44883, United States

Location

Toledo Hospital

Toledo, Ohio, 43606, United States

Location

St. Vincent Mercy Medical Center

Toledo, Ohio, 43608, United States

Location

Medical University of Ohio Cancer Center

Toledo, Ohio, 43614, United States

Location

CCOP - Toledo Community Hospital

Toledo, Ohio, 43617, United States

Location

Toledo Clinic, Incorporated - Main Clinic

Toledo, Ohio, 43623, United States

Location

Fulton County Health Center

Wauseon, Ohio, 43567, United States

Location

Avera Cancer Institute

Sioux Falls, South Dakota, 57105, United States

Location

Medical X-Ray Center, PC

Sioux Falls, South Dakota, 57105, United States

Location

Sanford Cancer Center at Sanford USD Medical Center

Sioux Falls, South Dakota, 57117-5039, United States

Location

Fredericksburg Oncology, Incorporated

Fredericksburg, Virginia, 22401, United States

Location

Franciscan Skemp Healthcare - La Crosse Campus

La Crosse, Wisconsin, 54601, United States

Location

Related Publications (3)

• Schild S, Graham D, Hillman S, et al.: Survival of patients (pts) treated with high-dose radiotherapy (RT) and concurrent chemotherapy for unresectable non-small cell lung cancer (NSCLC). [Abstract] J Clin Oncol 27 (Suppl 15): A-7544, 2009.

  RESULT

• Schild SE, McGinnis WL, Graham D, Hillman S, Fitch TR, Northfelt D, Garces YI, Shahidi H, Tschetter LK, Schaefer PL, Adjei A, Jett J. Results of a Phase I trial of concurrent chemotherapy and escalating doses of radiation for unresectable non-small-cell lung cancer. Int J Radiat Oncol Biol Phys. 2006 Jul 15;65(4):1106-11. doi: 10.1016/j.ijrobp.2006.02.046. Epub 2006 May 26.

  PMID: 16730134 RESULT

• Schild SE, Hillman SL, Tan AD, Ross HJ, McGinnis WL, Garces YA, Graham DL, Adjei AA, Jett JR; Mayo Clinic, North Central Cancer Treatment Group. Long-Term Results of a Trial of Concurrent Chemotherapy and Escalating Doses of Radiation for Unresectable Non-Small Cell Lung Cancer: NCCTG N0028 (Alliance). J Thorac Oncol. 2017 Apr;12(4):697-703. doi: 10.1016/j.jtho.2016.12.021. Epub 2017 Jan 12.

  PMID: 28089762 DERIVED

MeSH Terms

Conditions

Lung Neoplasms; Carcinoma, Non-Small-Cell Lung

Interventions

Carboplatin; 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)

Coordination Complexes; Organic Chemicals; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Diterpenes; Terpenes; Therapeutics

Study Officials

• Steven E. Schild, MD

  Mayo Clinic

  STUDY CHAIR

Study Design

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

Study Record Dates

• First Submitted: March 8, 2002
• First Posted: January 27, 2003
• Study Start: May 1, 2002
• Primary Completion: January 1, 2008
• Study Completion: January 1, 2010
• Last Updated: December 1, 2016

Record last verified: 2016-11

Locations

US (51)