Combination Chemotherapy, Radiation Therapy, and RSR13 in Treating Patients With Stage III Non-small Cell Lung Cancer

This study has been completed.
Sponsor:
Information provided by:
Spectrum Pharmaceuticals, Inc
ClinicalTrials.gov Identifier:
NCT00004202
First received: January 21, 2000
Last updated: May 8, 2013
Last verified: May 2013
  Purpose

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. Drugs such as RSR13 may make tumor cells more sensitive to radiation therapy.

PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy, radiation therapy, and RSR13 in treating patients who have stage III non-small cell lung cancer that cannot be removed by surgery.


Condition Intervention Phase
Lung Cancer
Drug: carboplatin
Drug: chemotherapy
Drug: efaproxiral
Drug: paclitaxel
Radiation: radiation therapy
Phase 2

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: A Phase II Study of Induction Chemotherapy With Paclitaxel and Carboplatin Followed by Radiation Therapy With RSR13 for Locally Advanced Inoperable Non-Small Cell Lung Cancer

Resource links provided by NLM:


Further study details as provided by Spectrum Pharmaceuticals, Inc:

Study Start Date: October 1998
Detailed Description:

OBJECTIVES: I. Determine the one year survival rate, two year survival rate, and median survival rate in patients with locally advanced unresectable non-small cell lung cancer treated with paclitaxel and carboplatin followed by radiotherapy plus RSR13. II. Determine the complete and partial response rates and progression free interval in the chest (radiation portal) of these patients on this regimen. III. Determine the time to disease progression outside of the radiation portal in these patients on this regimen. IV. Determine the toxic effects and adverse events associated with this regimen in these patients.

OUTLINE: This is a multicenter study. Induction chemotherapy: Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes every 3 weeks for 2 courses. Radiotherapy: Beginning 3 to 4 weeks after induction chemotherapy, patients receive RSR13 IV over 30 minutes, followed by fractionated radiotherapy 5 times weekly for 6-7 weeks. Patients are followed monthly for 2 months and then every 3 months thereafter until disease progression or death.

PROJECTED ACCRUAL: A total of 46-48 patients will be accrued for this study.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS: Histologically or cytologically confirmed locally advanced unresectable stage IIIA or IIIB non-small cell lung cancer (NSCLC), including: Squamous cell carcinoma OR Adenocarcinoma (including bronchoalveolar cell) OR Large cell anaplastic carcinoma (including giant and clear cell) OR Poorly differentiated NSCLC No small cell carcinoma No distant metastases Measurable or evaluable disease by chest x-ray, CT, or MRI scan Tumors adjacent to vertebral body are eligible if all gross disease is in the radiation boost field No pleural effusion(s) that are exudative, bloody, or cytologically malignant No asymptomatic brain metastases by CT or MRI scan

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 70-100% Life expectancy: At least 12 weeks Hematopoietic: Granulocyte count at least 2,000/mm3 Platelet count at least 100,000/mm3 Hemoglobin at least 10 g/dL (transfusion or epoetin alfa allowed) Hepatic: Bilirubin less than 1.5 times upper limit of normal Renal: Creatinine no greater than 1.5 mg/dL OR Creatinine clearance at least 50 mL/min Cardiovascular: No uncontrolled serious cardiac disease No active congestive heart failure, unstable angina, pericardial effusion, or arrhythmia Pulmonary: FVC or FEV1 at least 50% Resting or exercise SaO2 on room air at least 90% by pulse oximetry Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No active concurrent malignancy within the past 5 years, except: Nonmelanomatous skin cancer Carcinoma in situ of the cervix No serious medical or psychiatric illness that would preclude compliance No active serious infection No concurrent clinically significant peripheral neuropathy No prior significant allergic reaction to drugs containing Cremophor (e.g., cyclosporine or vitamin K) No greater than 10% weight loss in the past 3 months

PRIOR CONCURRENT THERAPY: Biologic therapy: At least 3 weeks since prior biologic therapy No concurrent immunotherapy (during radiotherapy (RT) and RSR13 administration) Chemotherapy: No prior systemic chemotherapy No concurrent chemotherapy (during RT and RSR13 administration) Endocrine therapy: No concurrent hormonal therapy (during RT and RSR13 administration) Radiotherapy: No prior radiotherapy to the thorax Surgery: At least 1 week since prior diagnostic thoracoscopy OR At least 3 weeks since prior thoracotomy and recovered No prior total surgical resection Other: At least 3 weeks since other prior investigational agents or devices No prior RSR13

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00004202

Locations
United States, Arizona
Arizona Cancer Center
Tucson, Arizona, United States, 85724
United States, California
Cedars-Sinai Comprehensive Cancer Center
Los Angeles, California, United States, 90048
United States, Kentucky
James Graham Brown Cancer Center
Louisville, Kentucky, United States, 40202
United States, Maryland
Johns Hopkins Oncology Center
Baltimore, Maryland, United States, 21287
United States, New York
Cancer Center of Albany Medical Center
Albany, New York, United States, 12208
United States, Ohio
Cleveland Clinic Cancer Center
Cleveland, Ohio, United States, 44195
United States, Tennessee
Boston Cancer Group
Memphis, Tennessee, United States, 38119
Dan Rudy Cancer Center
Nashville, Tennessee, United States, 37205
Vanderbilt Cancer Center
Nashville, Tennessee, United States, 37232-6838
United States, Virginia
Massey Cancer Center
Richmond, Virginia, United States, 23298-0037
Canada, Alberta
Tom Baker Cancer Center - Calgary
Calgary, Alberta, Canada, T2N 4N2
Cross Cancer Institute
Edmonton, Alberta, Canada, T6G 1Z2
Canada, Quebec
Centre Universitaire de Sante de l'Estrie - Site Fleurimont
Fleurimont, Quebec, Canada, J1H 5N4
Jewish General Hospital - Montreal
Montreal, Quebec, Canada, H3T 1E2
Montreal General Hospital
Montreal, Quebec, Canada, H3G 1A4
Notre Dame Hospital
Montreal, Quebec, Canada, H4L 2M1
Sponsors and Collaborators
Spectrum Pharmaceuticals, Inc
Investigators
Study Chair: Hak Choy, MD Vanderbilt-Ingram Cancer Center
  More Information

Additional Information:
Publications:
Nabid A, Choy H, Stea BD, et al.: Encouraging survival results with RSR13 and concurrent radiation therapy: interim analysis of a phase II study for locally advanced unresectable non-small cell lung cancer. [Abstract] Proceedings of the American Society of Clinical Oncology 21: A-1236, 2002.
Choy H, Swann S, Nabid A, et al.: Comparison of 5-year survival between RTOG-94-10 and a phase 2 study of induction chemotherapy followed by efaproxiral + radiotherapy in patients with locally advanced NSCLC. [Abstract] Int J Radiat Oncol Biol Phys 66 (3 Suppl 1): A-49, S28-9, 2006.

ClinicalTrials.gov Identifier: NCT00004202     History of Changes
Other Study ID Numbers: CDR0000067445, ALLOS-RSR13RT-010, VU-VCC-THO-9828
Study First Received: January 21, 2000
Last Updated: May 8, 2013
Health Authority: United States: Federal Government

Keywords provided by Spectrum Pharmaceuticals, Inc:
recurrent non-small cell lung cancer
stage IIIA non-small cell lung cancer
stage IIIB non-small cell lung cancer

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carboplatin
Paclitaxel
Efaproxiral
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antisickling Agents
Hematologic Agents
Radiation-Sensitizing Agents
Antineoplastic Agents, Phytogenic
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 28, 2014