Lung cancer is the number one cause of cancer death for both men and women in the United States. In the year 2001, it is estimated that 170,000 new cases of lung cancer will be diagnosed, approximately 20% of which will be small-cell lung cancer.
Little progress has been made in this disease in the last decade. Patients with limited disease are generally treated with cisplatin(Drug information on cisplatin) (Platinol)-based combination chemotherapy and radiotherapy, with a 5-year survival rate of approximately 20%. Patients with extensive disease are also treated with cisplatin-based combination chemotherapy, but the median survival duration for these patients is only 8 to 10 months, and long-term survival is rare. Clearly, current therapies are not satisfactory, and all patients should be considered for participation in well-designed clinical trials.[1-5]
A variety of novel drugs have been investigated as single agents in patients with small-cell lung cancer. Taxanes, particularly paclitaxel(Drug information on paclitaxel) (Taxol) have promising activity and are currently being investigated in combination with cisplatin and etoposide(Drug information on etoposide) in a randomized trial in patients with extensive disease. The topoisomerase I inhibitors topotecan(Drug information on topotecan) (Hycamtin) and irinotecan(Drug information on irinotecan) (CPT-11, Camptosar) also have single-agent activity and are being explored in combination with other agents in phase II trials. There are now a number of agents available that interfere with specific pathways or receptors both within and external to the malignant cell.
A variety of molecules are potential targets for therapy in small-cell lung cancer, including myc, p53, and Rb oncogenes as well as neuroendocrine, apoptotic, and angiogenic pathways. Several of these targeted therapies are currently being investigated in clinical trials and may hold promise. Many of these targets and potential new therapies were discussed in detail at a recent National Cancer Institute (NCI)-sponsored State of the Science meeting entitled "Molecular Targets for Therapy in Small-Cell Lung Cancer." Interested individuals can review the proceedings of this meeting on the Web at http://www.conference-cast.com/webtie/sots/sots.htm.
The following list includes approved and/or active protocols for patients with newly diagnosed small-cell lung cancer as well as studies for patients with recurrent disease sponsored by the Division of Cancer Treatment and Diagnosis of the NCI.
Phase III
Title: A Phase III, Double-Blind, Randomized Study of the
Effect of Megestrol(Drug information on megestrol) Acetate on Weight and Health-Related Quality of Life in Lung
Cancer Patients Receiving Thoracic Radiation Therapy
Protocol Number: 892
Participating Institutions: Wake Forest University Comprehensive Cancer
Center, East Carolina University, Greenville CCOP, Southeast Cancer Control
Consortium CCOP, Upstate Carolina CCOP, Virginia Commonwealth University
Protocol Status: In review
Contact: Edward G. Shaw, MD, (336) 716-4647
Title: Phase III Randomized Study of Etoposide and
Cisplatin With or Without Paclitaxel in Patients With Extensive Stage Small Cell
Lung Cancer
Protocol Number: 9732
Participating Institutions: Cancer and Leukemia Group B, Eastern
Cooperative Oncology Group, North Central Cancer Treatment Group, Southwest
Oncology Group
Protocol Status: Active
Contact: Harvey B. Niell, Cancer and Leukemia Group B, (901) 528-5798; for a complete listing of
study contacts, click here
Latest Information: http://cancernet.nci.nih.gov/
Title: Phase III Randomized Study of Donepezil(Drug information on donepezil) and Vitamin E(Drug information on vitamin e) in the Prevention of Cognitive Dysfunction Following Cancer Treatment
That Included Prophylactic Cranial Irradiation in Patients With Small Cell Lung
Cancer
Protocol Number: N99C5
Participating Institution: North Central Cancer Treatment Group
Protocol Status: Active
Contact: Aminah Jatoi, North Central Cancer Treatment Group, (507)
284-2511; for a complete listing of
study contacts, click here
Latest Information: http://cancernet.nci.nih.gov/
Phase II
Title: Phase II Study of Chloroquinoxaline Sulfonamide in
Patients With Platinum-Refractory Small Cell Lung Cancer
Protocol Number: 57
Participating Institutions: University of California at Davis
Protocol Status: Active
Contact: Primo N. Lara, University of California Davis Cancer Center, (916)
734-3772
Latest Information: http://cancernet.nci.nih.gov/
Title: Phase II Study of FR901228 in Patients With
Refractory or Progressive Small Cell or Non-Small Cell Lung Cancer
Protocol Number: 1053
Participating Institutions: National Cancer Institute Surgery Branch
Protocol Status: Active
Contact: David S. Schrump, Surgery Branch, (301) 496-2127
Latest Information: http://cancernet.nci.nih.gov/
Title: Phase II Study of Paclitaxel in Patients With
Extensive Stage Small Cell Lung Cancer
Protocol Number: 39901
Participating Institutions: Ellis Fischel Cancer Center - Columbia
Protocol Status: Active
Contact: Michael C. Perry, Ellis Fischel Cancer Center - Columbia, (573)
882-4979
Latest Information: http://cancernet.nci.nih.gov/
Title: Phase II Study of Gemcitabine(Drug information on gemcitabine) Plus Irinotecan in
Patients With Recurrent or Refractory Small Cell Lung Cancer
Protocol Number: CLB-39902
Participating Institution: Cancer and Leukemia Group B
Protocol Status: Active
Contact: Caio Max S. Rocha Lima, Cancer and Leukemia Group B, (843)
792-4271; for a complete listing of
study contacts, click here
Latest Information: http://cancernet.nci.nih.gov/
Title: Phase II Study of Topotecan and Paclitaxel in
Patients With Recurrent or Refractory Small Cell Lung Cancer
Protocol Number: NCCTG-972051
Participating Institution: North Central Cancer Treatment Group
Protocol Status: Active
Contact: James R. Jett, North Central Cancer Treatment Group, (507)
284-3764; for a complete listing of
study contacts, click here
Latest Information: http://cancernet.nci.nih.gov/
Title: A Phase II Randomized Trial With Captopril(Drug information on captopril) (Capoten)
in Patients Who Have Received Radiation Therapy ± Chemotherapy for Stage
II-IIIA Non-Small-Cell Lung Cancer or Limited-Stage Small-Cell Lung Cancer
Protocol Number: RTOG-L-0123
Participating Institutions: Radiation Therapy Oncology
Group, Northwestern Memorial Hospital
Protocol Status: In review
Contact: Elaine Pakuris, (215) 574-3195
Title: Phase II Study of Paclitaxel, Carboplatin(Drug information on carboplatin),
Topotecan, and Filgrastim(Drug information on filgrastim) (G-CSF) in Patients With Previously Untreated
Extensive Stage Small Cell Lung Cancer
Protocol Number: S9914
Participating Institution: Southwest Oncology Group
Protocol Status: Active
Contact: Frank Dunphy, Southwest Oncology Group, (919) 684-5808; for a complete listing of
study contacts, click here
Latest Information: http://cancernet.nci.nih.gov/
Title: Phase II Study of Fenretinide in Patients With
Recurrent Small Cell Lung Cancer
Protocol Number: T99-0112
Participating Institutions: University of Michigan Comprehensive Cancer
Center
Protocol Status: Active
Contact: Gregory P. Kalemkerian, University of Michigan Comprehensive
Cancer Center, (734) 936-5281
Latest Information: http://cancernet.nci.nih.gov/
Phase I/II
Title: Phase I/II Study of Topotecan and Paclitaxel
Preceding and Following High Dose Thoracic Radiotherapy With Concurrent
Cisplatin, Etoposide, and Amifostine(Drug information on amifostine) in Patients With Limited Stage Small Cell
Lung Cancer
Protocol Number: N9923
Participating Institution: North Central Cancer Treatment Group
Protocol Status: Active
Contact: Scott Okuno, North Central Cancer Treatment Group, (507)
284-2511; for a complete listing of
study contacts, click here
Latest Information: http://cancernet.nci.nih.gov/
Title: A Phase I/II Dose Escalation Study of Thoracic
Irradiation With Concurrent Chemotherapy for Patients With Limited Small-Cell
Lung Cancer
Protocol Number: RTOG-97-12
Participating Institution: Radiation Therapy Oncology Group
Protocol Status: In review
Contact: Elaine Pakuris, (215) 574-3195
Title: A Phase I/II Study of G3139, a BCL-2 Antisense
Oligonucleotide, Combined With Paclitaxel for the Treatment of Recurrent
Small-Cell Lung Cancer
Protocol Number: T98-0091
Participating Institutions: University of Chicago, Lutheran General
Hospital, University of Illinois, Weiss Memorial Hospital, Decatur Memorial
Hospital, Oncology-Hematology Associates, Kellogg Cancer Center- Evanston
Hospital, Michiana Hematology-Oncology Professional Corporation, Ohio State
University Hospital, Fort Wayne Medical Oncology-Hematology Incorporated,
Central Illinois Hematology Oncology Center
Protocol Status: In review
Contact: Charles M. Rudin, MD, (773) 702-9306
Phase I
Title: Phase I Study of Tirapazamine, Cisplatin, and
Etoposide Concurrently With Radiotherapy in Patients With Limited Stage Small
Cell Lung Cancer
Protocol Number: SWOG-0004
Participating Institution: Southwest Oncology Group
Protocol Status: Active
Contact: Quynh-Thu Le, Southwest Oncology Group, (650) 723-6171; for a complete listing of
study contacts, click here
Latest Information: http://cancernet.nci.nih.gov/
Title: Phase I Study of Decitabine Mediated Induction of
Tumor Antigen and Tumor Suppressor Gene Expression in Patients With Unresectable
Lung or Esophageal Cancer, or Malignant Pleural Mesothelioma
Protocol Number: T99-0012
Participating Institution: National Cancer Institute Surgery Branch
Protocol Status: Active
Contact: David S. Schrump, Surgery Branch, (301) 496-2127
Latest Information: http://cancernet.nci.nih.gov/
Other
Title: Detection of Tumor Cells in Marrow and Blood of
Patients With Limited-Stage Small-Cell Lung Cancer at Diagnosis and After First
Response
Protocol Number: CALGB-159803
Participating Institution: Cancer and Leukemia Group B
Protocol Status: In review
Contact: CALGB Central Office, (773) 702-9171
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