H. Lee Moffitt Cancer Center & Research Institute

Clinical Research Protocols

Clinical Research Protocols for Lung Cancer and Mesothelioma

Compiled by Margaret Gross-King, RN, MS, OCN
Clinical Research Manager, H. Lee Moffitt Cancer Center & Research Institute


This list of clinical research protocols relating to lung cancer and mesothelioma
is compiled for your convenience.


Neoadjuvant NSCLC

RTOG-9309, INT-0139, CLB-9592 NCI HIGH PRIORITY CLINICAL TRIAL -- Phase III Randomized Study of Concurrent Radiotherapy and CDDP/VP-16 With vs Without Surgical Resection for Stage IIIA (N2) Non-Small-Cell Lung Cancer (summary last modified 02/97).

Chairperson: David S. Ettinger. Lead organization: Radiation Therapy Oncology Group. Age range: 18 and over.

CLB-9531 Phase II Study of High- Dose CBDCA/TAX With G-CSF and PBSC Support Followed by Surgery and/or Radiotherapy for Stage III Non-Small-Cell Lung Cancer (summary last modified 11/96).

Chairperson: Thomas C. Shea. Lead organization: Cancer and Leukemia Group B. Age range: 18 to 64.

SWOG-9416, INT-0160, CLB-9495 Phase II Pilot Study of Induction With CDDP/VP-16 Plus Radiotherapy Followed by Surgery and Adjuvant CDDP/VP-16 for Non- Small-Cell Lung Cancer Involving the Superior Sulcus (Pancoast Tumors) (summary last modified 06/96).

Chairperson: Valerie W. Rusch. Lead organization: Southwest Oncology Group. Age range: adult.

Adjuvant NSCLC

CLB-9633, CLB-C9633 Phase III Randomized Study of Carboplatin/ Paclitaxel vs No Adjuvant Chemotherapy After Resection of Stage I (T2N0) Non-Small-Cell Lung Cancer (summary last modified 06/97).

Chairperson: Gary M. Strauss.
Lead organization: Cancer and Leukemia Group B. Age range: 18 and over.

CAN-NCIC-BR10, NCI-V94-0492, E-JBR10 Phase III Randomized Study of Adjuvant Chemotherapy With VNB/CDDP vs No Adjuvant Chemotherapy for Completely Resected Non-Small-Cell Lung Cancer (summary last modified 08/96).

Chairperson: Timothy Winton. Lead organization: NCIC-Clinical Trials Group. Age range: 18 and over.

SWOG-9416, INT-0160, CLB-9495 Phase II Pilot Study of Induction With CDDP/VP-16 Plus Radiotherapy Followed by Surgery and Adjuvant CDDP/VP-16 for Non-Small-Cell Lung Cancer Involving the Superior Sulcus (Pancoast Tumors) (summary last modified 06/96).

Chairperson: Valerie W. Rusch. Lead organization: Southwest Oncology Group. Age range: adult.

Advanced NSCLC

JHOC-T94-0133, NCI-T94-0133D Phase II Study of Aminocamptothecin in Advanced Non-Small-Cell Lung Cancer (summary last modified 06/95).

Chairperson: David S. Ettinger. Lead organization: Johns Hopkins Oncology Center. Age range: over 18.

VU-VCC-LUN-65, NCI-T92-0246D Phase I Study of Paclitaxel (Taxol) Plus Thoracic Radiotherapy for Previously Untreated Clinical Stage III Non-Small-Cell Lung Cancer (summary last modified 04/97).

Chairperson: David P. Carbone. Lead organization: Vanderbilt Cancer Center. Age range: 18 and over.

NYU-9301, NCI-T93-0015D Phase I Study of Prolonged Low-Dose Topotecan Infusion Combined With Chest Irradiation in Patients With Non-Small-Cell Lung Cancer (summary last modified 10/96).

Chairperson: Howard S. Hochster. Lead organization: Kaplan Comprehensive Cancer Center. Age range: 18 and over.

MSKCC-95088, NCI-V96-0830, RP- 56976-TAX-320 Phase III Randomized Study of High-Dose vs Low-Dose Docetaxel vs Standard Chemotherapy With VNB or IFF for Non-Small-Cell Lung Cancer Previously Treated With Platinum-Based Chemotherapy (summary last modified 12/96).

Chairperson: Vincent A. Miller. Lead organization: Memorial Sloan-Kettering Cancer Center. Age range: 18 and over.

MSKCC-95056, NCI-V95-0770 Phase I/II Study of TXT/VNB With G-CSF for Stage IIIB/IV Non-Small-Cell Lung Cancer (summary last modified 12/96).

Chairperson: Vincent A. Miller. Lead organization: Memorial Sloan-Kettering Cancer Center. Age range: 18 and over.

E-1594 Phase III Randomized Study of Standard Chemotherapy With Paclitaxel/Cisplatin vs Gemcitabine/ Cisplatin vs Docetaxel/Cisplatin vs Paclitaxel/Carboplatin in Metastatic Non-Small-Cell Lung Cancer (summary last modified 04/97).

Chairperson: Joan Hoff Schiller, University of Wisconsin Comprehensive Cancer Center. Lead organization: Eastern Cooperative Oncology Group. Age range: 18 and over.

CLB-9431 Phase II Randomized Study of Cisplatin Combined With Paclitaxel, Gemcitabine, or Vinorelbine Followed by Concomitant Chemoradiotherapy for Inoperable Stage IIIA/IIIB Non-Small-Cell Lung Cancer (summary last modified 12/96).

Chairperson: Everett Vokes. Lead organization: Cancer and Leukemia Group B. Age range: 18 and over.

NCCTG-942452 Phase III Randomized Study of Concurrent EP (CDDP/VP-16) and Standard vs Accelerated Hyperfractionated Thoracic Irradiation for Unresectable Stage IIIA/B Non-Small-Cell Lung Cancer (summary last modified 07/95).

Chairperson: James A. Bonner. Lead organization: North Central Cancer Treatment Group. Age range: 18 and over.

SWOG-9509 Phase III Randomized Study of TAX/CBDCA vs VNB/ CDDP for Stage IV and Selected Stage IIIB Non-Small-Cell Lung Cancer (summary last modified 04/97).

Chairperson: Karen Kelly. Lead organization: Southwest Oncology Group. Age range: 18 and over.

SWOG-9504 Phase II Study of CDDP/VP-16 Plus Radiotherapy Followed by TXT for Stage IIIB Non-Small-Cell Lung Cancer (summary last modified 08/96).

Chairperson: David R. Gandara, University of California-Davis. Lead organization: Southwest Oncology Group. Age range: adult.

RTOG-9304 Phase III Randomized Study of Conventional Radiotherapy With vs Without IFN-B in Patients With Locally Advanced Non-Small-Cell Lung Cancer (summary last modified 09/96).

Chairperson: Philip Rubin, University of Rochester Cancer Center. Lead organization: Radiation Therapy Oncology Group. Age range: 18 and over.

RTOG-9311 Phase I/II Dose Escalation Study of 3-D Conformal Radiotherapy for Locally Advanced, Inoperable, Non-Small-Cell Lung Cancer (summary last modified 07/96).

Chairperson: Bahman N. Emami. Lead organization: Radiation Therapy Oncology Group. Age range: 18 and over.

RTOG-9410 Phase III Randomized Study of Standard Thoracic Irradiation Following VBL/CDDP vs Standard Thoracic Irradiation and Concurrent VBL/CDDP vs Hyperfractionated Thoracic Irradiation and Concurrent VP-16/CDDP for Locally Advanced, Unresectable, Non- Small-Cell Lung Cancer (summary last modified 08/96).

Chairperson: Walter John Curran, Jr. Lead organization: Radiation Therapy Oncology Group. Age range: 18 and over.

Supportive Care for NSCLC

MDA-ID-91025, NCI-P92-0014, I91-0001, INT-0125, CLB-9293 Phase III, Double-Blind, Randomized Trial of 13-CRA vs Placebo to Prevent Second Primary Tumors in Patients With Totally Resected Stage I Non-Small-Cell Lung Cancer (summary last modified 06/97).

Chairperson: Scott Michael Lippman. Lead organization: University of Texas - M.D. Anderson Cancer Center. Age range: 18 and over.

E-4Z93, NCI-P93-0051 Oral Analgesia Regimen for Improved Pain Control in Cancer Patients (summary last modified 02/97).

Chairperson: Charles Cleeland, University of Texas - M.D. Anderson Cancer Center. Lead organization: Eastern Cooperative Oncology Group. Age range: 18 and over.

E-1Y92, NCI-P93-0042 Randomized Study to Evaluate the Efficacy of Brief Physician-Initiated Quit -Smoking Strategies for Clinical Oncology Settings (summary last modified 08/95).

Chairperson: C. Tracy Orleans,
Fox Chase Cancer Center. Lead organization: Eastern Cooperative Oncology Group. Age range: 19 and over.

Mesothelioma

SVMC-V89-0296, NCI-V89-0296 Phase I/II Study of High-Dose Megestrol in Breast or Endometrial Carcinoma or Mesothelioma (summary last modified 11/92).

Chairperson: Charles L. Wiseman. Lead organization: St. Vincent Medical Center. Age range: at least 18.

CAN-OTT-9401, NCI-V-94-0566 Phase II Study of Cisplatin/Doxorubicin/Tamoxifen for Incurable Soft Tissue and Endocrine Malignancies (summary last modified 12/96).

Chairperson: S. Gertler. Lead organization:Ottawa Regional Cancer Centre-Civic Division. Age range: 65 and under.

MSKCC-93153, NCI-V94-0418 Phase II Study of Surgical Resection, High-Dose-Rate Intraoperative Brachytherapy, and External-Beam Radiotherapy for Malignant Pleural Mesothelioma (summary last modified 06/95).

Chairperson: Valerie W. Rusch. Lead organization: Memorial Sloan-Kettering Cancer Center. Age range: any age.

SCCC-9072, NCI-V92-0063 Phase II Study of DOX/Prochlorperazine in Patients With Malignant Mesothelioma (summary last modified 07/92).

Chairperson: Kasi S. Sridhar. Lead organization: Sylvester Cancer Center, University of Miami. Age range: over 18.

CLB-9631 Phase II Study of High- Dose Doxorubicin With Dexrazoxane Cardioprotection and GM-CSF for Advanced Malignant Mesothelioma (summary last modified 05/97).

Chairperson: Michael Paul Kosty. Lead organization: Cancer and Leukemia Group B. Age range: any age.

Legend for Abbreviations:

CAN-NCIC = National Cancer Institute of Canada
CAN-0TT = Ottawa Regional Cancer Centre
CLB = Cancer and Leukemia Group B
E = Eastern Cooperative Oncology Group
JHOC = Johns Hopkins Oncology Center
MDA = M.D. Anderson Cancer Center
MSKCC = Memorial Sloan-Kettering Cancer Center
NCCTG = North Central Cancer Treatment Group
NYU = New York University
RTOG = Radiation Therapy Oncology Group
SCCC = Sylvester Comprehensive Cancer Center
SVMC = St. Vincent Medical Center
SWOG = Southwest Oncology Group
VU = Vanderbilt University


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