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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


Phase 2
18 Years
N/A
Not Enrolling
Both
Lung Cancer

Thank you

Trial Information

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


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Hak Choy, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Vanderbilt-Ingram Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000067445

NCT ID:

NCT00004202

Start Date:

October 1998

Completion Date:

Related Keywords:

  • Lung Cancer
  • recurrent non-small cell lung cancer
  • stage IIIA non-small cell lung cancer
  • stage IIIB non-small cell lung cancer
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

Name

Location

Arizona Cancer CenterTucson, Arizona  85724
Johns Hopkins Oncology CenterBaltimore, Maryland  21287
Cancer Center of Albany Medical CenterAlbany, New York  12208
Cleveland Clinic Cancer CenterCleveland, Ohio  44195
Vanderbilt Cancer CenterNashville, Tennessee  37232-6838
James Graham Brown Cancer CenterLouisville, Kentucky  40202
Massey Cancer CenterRichmond, Virginia  23298-0037
Boston Cancer GroupMemphis, Tennessee  38119
Cedars-Sinai Comprehensive Cancer CenterLos Angeles, California  90048
Dan Rudy Cancer CenterNashville, Tennessee  37205