Gemcitabine, Carboplatin or Paclitaxel Plus Radiation Therapy in Treating Patients With Stage IIIA or IIIB Non-Small Cell Lung Cancer

NCT00016315 | Completed Phase 1 DMC

• 3 other identifiers: RTOG-0017RTOG-L-0017CDR0000068622
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 19

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as gemcitabine, carboplatin, and paclitaxel, work in 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 radiation therapy with chemotherapy may kill more tumor cells. PURPOSE: Phase I trial to study the effectiveness of combining combination chemotherapy with radiation therapy in treating patients who have stage IIIA or stage IIIB non-small cell lung cancer.

Conditions

Lung Cancer

Keywords

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

Outcome Measures

Primary Outcomes (2)

• To determine the maximum tolerated dose of gemcitabine with carboplatin-based chemotherapy and radiation therapy

  From start of treatment to 90 days

• To determine the maximum tolerated dose of gemcitabine with paclitaxel-based chemotherapy and radiation therapy

  From start of treatment to 90 days

Study Arms (13)

Arm 1

EXPERIMENTAL

Sequence A: Gemcitabine 300 mg/m2/week plus radiation therapy (RT)

Drug: gemcitabine hydrochloride; Radiation: radiation therapy

Arm 2

EXPERIMENTAL

Sequence B: Gemcitabine 300 mg/m2/week plus paclitaxel 30 mg/m2/week and RT

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

Arm 3

EXPERIMENTAL

Sequence A: Gemcitabine 300 mg/m2/week plus carboplatin 2 AUC and RT

Drug: carboplatin; Drug: gemcitabine hydrochloride; Radiation: radiation therapy

Arm 4

EXPERIMENTAL

Sequence B: Gemcitabine 450 mg/m2/week plus paclitaxel 30 mg/m2/week and RT

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

Arm 6

EXPERIMENTAL

Sequence B: Gemcitabine 450 mg/m2/week plus paclitaxel 40 mg/m2/week and RT

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

Arm 8

EXPERIMENTAL

Sequence B: Gemcitabine 600 mg/m2/week plus paclitaxel 40 mg/m2/week and RT

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

Arm 10

EXPERIMENTAL

Sequence B: Gemcitabine 600 mg/m2/week plus paclitaxel 50 mg/m2/week and RT

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

Arm 12

EXPERIMENTAL

Sequence B: Gemcitabine 750 mg/m2/week plus paclitaxel 50 mg/m2/week and RT

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

Arm 14

EXPERIMENTAL

Sequence B: Gemcitabine 900 mg/m2/week plus paclitaxel 50 mg/m2/week and RT

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

Arm 5

EXPERIMENTAL

Sequence A: Gemcitabine 450 mg/m2/week plus carboplatin 2 AUC and RT

Drug: carboplatin; Drug: gemcitabine hydrochloride; Radiation: radiation therapy

Arm 7

EXPERIMENTAL

Sequence A: Gemcitabine 600 mg/m2/week plus carboplatin 2 AUC and RT

Drug: carboplatin; Drug: gemcitabine hydrochloride; Radiation: radiation therapy

Arm 9

EXPERIMENTAL

Sequence A: Gemcitabine 750 mg/m2/week plus carboplatin 2 AUC and RT

Drug: carboplatin; Drug: gemcitabine hydrochloride; Radiation: radiation therapy

Arm 11

EXPERIMENTAL

Sequence A: Gemcitabine 900 mg/m2/week plus carboplatin 2 AUC and RT

Drug: carboplatin; Drug: gemcitabine hydrochloride; Radiation: radiation therapy

Interventions

carboplatin DRUG

Arm 11; Arm 3; Arm 5; Arm 7; Arm 9

gemcitabine hydrochloride DRUG

Arm 1; Arm 10; Arm 11; Arm 12; Arm 14; Arm 2; Arm 3; Arm 4; Arm 5; Arm 6; Arm 7; Arm 8; Arm 9

paclitaxel DRUG

Arm 10; Arm 12; Arm 14; Arm 2; Arm 4; Arm 6; Arm 8

radiation therapy RADIATION

Arm 1; Arm 10; Arm 11; Arm 12; Arm 14; Arm 2; Arm 3; Arm 4; Arm 5; Arm 6; Arm 7; Arm 8; Arm 9

Eligibility Criteria

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

DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed loco-regionally advanced non-small cell lung cancer meeting one of the following staging criteria: * Medically inoperable stage IIIA * Unresectable stage IIIA or IIIB * Measurable disease on three-dimensional planning CT scan * No post-resection intrathoracic tumor recurrence * No pleural effusion on chest x-ray except those occurring after attempted thoracotomy or other invasive thoracic procedure * No evidence of small cell histology * No evidence of hematogenous or distant metastases PATIENT CHARACTERISTICS: Age: * Not specified Performance status: * Zubrod 0-1 Life expectancy: * Not specified Hematopoietic: * Platelet count at least 100,000/mm\^3 * Absolute granulocyte count at least 2,000/mm\^3 * Hemoglobin at least 8.0 g/dL Hepatic: * Bilirubin no greater than 1.5 mg/dL * Serum glutamate oxaloacetate transaminase (SGOT) no greater than 1.5 times upper limit of normal (unless caused by documented benign disease) Renal: * Creatinine no greater than 1.5 mg/dL Cardiovascular: * No myocardial infarction within the past 6 months * No symptomatic heart disease, including angina, congestive heart failure, or uncontrolled arrhythmia Pulmonary: * Forced expiratory volume (FEV)\_1 greater than 1,000 mL Other: * No other invasive malignancy within the past 3 years except nonmelanoma skin cancer * No weight loss of more than 10% in 3 months prior to diagnosis * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: * Not specified Chemotherapy: * No prior chemotherapy Endocrine therapy: * Not specified Radiotherapy: * No prior thoracic or neck radiotherapy Surgery: * See Disease Characteristics * No prior complete or subtotal tumor resection

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

Sponsors & Collaborators

• Radiation Therapy Oncology Group: lead
• National Cancer Institute (NCI): collaborator

Study Sites (19)

CCOP - Bay Area Tumor Institute

Oakland, California, 94609-3305, United States

Location

University of Miami Sylvester Comprehensive Cancer Center

Miami, Florida, 33136, United States

Location

Wendt Regional Cancer Center of Finley Hospital

Dubuque, Iowa, 52001, United States

Location

Monmouth Medical Center

Long Branch, New Jersey, 07740-6395, United States

Location

Akron City Hospital

Akron, Ohio, 44304, United States

Location

Cancer Care Center, Incorporated

Salem, Ohio, 44460, United States

Location

Delaware County Memorial Hospital

Drexel Hill, Pennsylvania, 19026, United States

Location

Dale and Frances Hughes Cancer Center

East Stroudsburg, Pennsylvania, 18301, United States

Location

Mercy Hospital of Pittsburgh

Pittsburgh, Pennsylvania, 15219, United States

Location

Vanderbilt-Ingram Cancer Center at Vanderbilt Medical Center

Nashville, Tennessee, 37232-5671, United States

Location

Cottonwood Hospital Medical Center

Murray, Utah, 84107, United States

Location

McKay-Dee Hospital Center

Ogden, Utah, 84403, United States

Location

Utah Valley Regional Medical Center - Provo

Provo, Utah, 84604, United States

Location

LDS Hospital

Salt Lake City, Utah, 84143, United States

Location

Dixie Regional Medical Center

St. George, Utah, 84770, United States

Location

Danville Regional Medical Center

Danville, Virginia, 24541, United States

Location

Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center

La Crosse, Wisconsin, 54601, United States

Location

Medical College of Wisconsin Cancer Center

Milwaukee, Wisconsin, 53226, United States

Location

Veterans Affairs Medical Center - Milwaukee (Zablocki)

Milwaukee, Wisconsin, 53295, United States

Location

Related Publications (3)

• Choy H, Jain AK, Moughan J, Curran W, Whipple G, Demas WF, Ettinger DS. RTOG 0017: a phase I trial of concurrent gemcitabine/carboplatin or gemcitabine/paclitaxel and radiation therapy ("ping-pong trial") followed by adjuvant chemotherapy for patients with favorable prognosis inoperable stage IIIA/B non-small cell lung cancer. J Thorac Oncol. 2009 Jan;4(1):80-6. doi: 10.1097/JTO.0b013e318191503f.

  PMID: 19096311 RESULT

• Choy H, Swann S, Curran W, et al.: A phase I trial of gemcitabine, carboplatin or gemcitabine, paclitaxel and concurrent radiation therapy followed by consolidative gemcitabine and carboplatin for inoperable stage III non-small cell lung cancer: an RTOG 0017 study. [Abstract] Int J Radiat Oncol Biol Phys 63 (2 Suppl 1): A-70, S42, 2005.

  RESULT

• Choy H, Swann S, Walter C, et al.: A phase I trial of gemcitabine, carboplatin or gemcitabine, paclitaxel and concurrent radiation therapy followed by consolidative gemcitabine and carboplatin for inoperable stage III non-small cell lung cancer: an RTOG study. [Abstract] J Clin Oncol 23 (Suppl 16): A-7103, 646s, 2005.

  RESULT

MeSH Terms

Conditions

Lung Neoplasms; Carcinoma, Non-Small-Cell Lung

Interventions

Carboplatin; 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)

Coordination Complexes; Organic Chemicals; Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Diterpenes; Terpenes; Therapeutics

Study Officials

• Hak Choy, MD

  Simmons Cancer Center

  STUDY CHAIR

Study Design

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

Study Record Dates

• First Submitted: May 6, 2001
• First Posted: May 7, 2003
• Study Start: May 1, 2001
• Primary Completion: January 1, 2009
• Study Completion: June 1, 2010
• Last Updated: November 17, 2015

Record last verified: 2015-11

Locations

US (19)