NCT00006378

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: Randomized phase II trial to compare the effectiveness of three different regimens of combining paclitaxel and carboplatin plus radiation therapy in treating patients who have stage III non-small cell lung cancer that cannot be removed during surgery.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5

participants targeted

Target at below P25 for phase_2 lung-cancer

Timeline
Completed

Started Dec 1999

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 1999

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

October 4, 2000

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2003

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2003

Completed
1.2 years until next milestone

First Posted

Study publicly available on registry

June 9, 2004

Completed
Last Updated

January 9, 2014

Status Verified

January 1, 2014

Enrollment Period

3.3 years

First QC Date

October 4, 2000

Last Update Submit

January 8, 2014

Conditions

Lung Cancer

Keywords

squamous cell lung cancerlarge cell lung cancerstage IIIA non-small cell lung cancerstage IIIB non-small cell lung canceradenocarcinoma of the lungadenosquamous cell lung cancerbronchoalveolar cell lung cancer

Interventions

carboplatinDRUG
paclitaxelDRUG
radiation therapyRADIATION

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: Histologically or cytologically confirmed non-small cell lung cancer (NSCLC) Stage IIIA (T1-2, N2, M0 or T3, N1-2, M0) if not medically operable Stage IIIB (any T, N3, M0 or T4, any N, M0) Radiographic evidence of mediastinal lymph nodes at least 2.0 cm in the largest diameter sufficient to stage N2 or N3 disease If largest mediastinal node is less than 2.0 cm in diameter and is the basis for stage III disease, then at least one node must be histologically or cytologically confirmed positive Any of the following histologies allowed: Squamous cell carcinoma Adenocarcinoma (including bronchoalveolar cell) Large cell anaplastic carcinoma (including giant and clear cell carcinomas) Poorly differentiated NSCLC No metastatic disease Patients with tumors adjacent to a vertebral body allowed if all gross disease can be encompassed in the radiation boost field (boost volume must be limited to less than 50% of the ipsilateral lung volume) Pleural effusions that are a transudate, cytologically negative, and non-bloody are allowed if tumor can be encompassed within reasonable field of radiotherapy Pleural effusions that can be seen on chest CT but not on chest x-ray and are too small to tap are allowed No brain metastases by MRI or CT scan No prior total surgical resection PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 70-100% Life expectancy: Not specified Hematopoietic: Granulocyte count at least 2,000/mm3 Platelet count at least 100,000/mm3 Hemoglobin greater than 8 g/dL (transfusion or epoetin alfa allowed) Hepatic: Bilirubin less than 1.5 times normal Renal: Creatinine clearance greater than 50 mL/min Cardiovascular: No history of uncontrolled serious cardiac disease No myocardial infarction within the past 6 months No congestive heart failure No unstable angina No clinically significant pericardial effusion or arrhythmia Pulmonary: FEV1 greater than 800 mL Post obstructive pneumonia allowed Other: No other active concurrent or prior malignancy within the past 5 years except nonmelanomatous skin cancer or carcinoma in situ of the cervix No other serious medical or psychiatric illness that would preclude study No active serious infection No prior significant allergic reactions to drugs containing Cremophor (e.g., cyclosporine or vitamin K) No weight loss of more than 10% within 3 months prior to diagnosis Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent colony stimulating factors (i.e., filgrastim (G-CSF) or sargramostim (GM-CSF)) No concurrent immunotherapy Concurrent epoetin alfa allowed Chemotherapy: No prior systemic chemotherapy No other concurrent chemotherapy Endocrine therapy: No concurrent hormonal agents except for nondisease related conditions (e.g., insulin for diabetes) Concurrent steroids administered for adrenal failure or septic shock allowed Concurrent glucocorticosteroids as antiemetics allowed Radiotherapy: No prior radiotherapy to the thorax Surgery: See Disease Characteristics At least 3 weeks since formal exploratory thoracotomy and recovered At least 1 week since prior diagnostic thoracoscopy Other: No other concurrent anticancer drugs

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

Sponsors & Collaborators

Study Sites (3)

Morristown Memorial Hospital

Morristown, New Jersey, 07962-1956, United States

Location

Cancer Institute of New Jersey

New Brunswick, New Jersey, 08901, United States

Location

University Hospitals of Cleveland

Cleveland, Ohio, 44106, United States

Location

Related Publications (1)

  • Bonomi P, Curran W, Choy H, et al.: Randomized 3-arm phase II study of paclitaxel (T), carboplatin (C), and thoracic radiation (TRT) for patients with stage III non-small cell lung cancer (NSCLC). Report of locally advanced multimodality protocol (LAMP) - ACR 427. [Abstract] Lung Cancer 41 (Suppl 2): A-O-263, S77, 2003.

    RESULT

MeSH Terms

Conditions

Lung NeoplasmsCarcinoma, Non-Small-Cell LungAdenocarcinoma of LungAdenocarcinoma, Bronchiolo-Alveolar

Interventions

CarboplatinPaclitaxelRadiotherapy

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract DiseasesCarcinoma, BronchogenicBronchial NeoplasmsAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Coordination ComplexesOrganic ChemicalsTaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsDiterpenesTerpenesTherapeutics

Study Officials

  • Nathan Levitan, MD

    Case Comprehensive Cancer Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Purpose
TREATMENT
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 4, 2000

First Posted

June 9, 2004

Study Start

December 1, 1999

Primary Completion

April 1, 2003

Study Completion

April 1, 2003

Last Updated

January 9, 2014

Record last verified: 2014-01

Locations

US(3)