H. Lee Moffitt Cancer Center & Research Institute

Clinical Research Protocols For
Oncology Support And Palliation


This list of clinical research protocols relating to oncology support and palliation is compiled for your convenience.

Pain Control

CAN-NCIC-PR6 Phase III Randomized Study of Mitoxantrone and Prednisone With or Without Clodronate in Patients With Hormone Refractory Metastatic Prostate Cancer and Pain.

Chairperson: D. Scott Ernst. Telephone: 403-670-1761. Lead organization: NCIC-Clinical Trials Group. Age range: any age.

RPCI-DS-95-35, NCI-G97-1352 Phase III Study of Epidural Hydromorphone versus Intravenous Hydromorphone in Postoperative Radical Prostatectomy Patients.

Chairperson: Robert P. Sands,Jr. Telephone: 716-845-8630. Lead organization: Roswell Park Cancer Institute. Age range: 18-70.

DIATIDE-117-22 Phase II Randomized Study of Tin Sn 117m DTPA versus Placebo in Patients With Painful Osteolytic Bone Metastases.

Chairperson: Nancy J. Mulrow. Telephone: 603-437-8970. Lead organization: Diatide, Inc. Age range: 18 and over.

DIATIDE-117-30, UCMC-97012201 Phase II Study of Sn-117m DTPA versus Strontium-89 in Patients With Painful Bone Metastases Secondary to Prostate Cancer.

Chairperson: Nancy J. Mulrow. Telephone: 603-437-8970. Lead organization: Diatide, Inc. Age range: 18 and over.

E-1Z95 Phase II Study of Flecainide for the Treatment of Chronic Neuropathic Pain.

Chairperson: Charles F. Von Gunten. Telephone: 312-908-9412. Lead organization: Eastern Cooperative Oncology Group. Age range: over 18.

RPCI-DS-92-13, NCI-V97-1251 Randomized Study of the Peripheral Effects of Opioid Analgesia in Patients With Breast Cancer Undergoing Axillary Node Dissection.

Chairperson: Anthony T. Yarussi. Telephone: 716-845-8630. Lead organization: Roswell Park Cancer Institute.

Age range: no age specified.

E-3Z93, NCI-P95-0068 Randomized Pilot Study to Evaluate Educational Intervention and Behavioral Skills Training for Pain Control in Patients With Recurrent or Metastatic Breast or Prostate Cancer.

Chairperson: Charles Cleeland. Telephone: 713-745-3470. Lead organization: Eastern Cooperative Oncology Group. Age range: 18 and over.

E-4Z93, NCI-P93-0051 Oral Analgesia Regimen for Improved Pain Control in Cancer Patients.

Chairperson: Charles Cleeland. Telephone: 713-745-3470. Lead organization: Eastern Cooperative Oncology Group. Age range: 18 and over.

Symptom Management/ Quality of Life

NCCTG-969257, NCI-P98-013 Phase III Randomized Study of Oral Capsaicin Lozenges for Radiation Induced Mucositis.

Chairperson: Michael J. O’Connell. Telephone: 507-266-4997. Lead organization: North Central Cancer Treatment Group. Age range: 18 and over.

CAN-NCIC-HN2 Phase III Study of Bacitracin, Clotrimazole, and Gentamicin (BCOG) Lozenges versus Placebo Lozenges in Patients Undergoing Radiotherapy for Oral, Pharyngeal, or Laryngeal Cancer.

Chairperson: Samy El-Sayed. Telephone: 204-787-2153. Lead organization: NCIC-Clinical Trials Group. Age range: 16 and over.

RTOG-9709, NCI-P97-0121 Phase III Study of the Prophylactic Use of Oral Pilocarpine to Reduce Hyposalivation and Mucositis Associated With Curative Radiation Therapy in Patients With Head and Neck Cancer.

Chairperson: Francis LeVeque. Telephone: 313-745-9300. Lead organization: Radiation Therapy Oncology Group. Age range: 18 and over.

RTOG-9801 Phase III Randomized Study of Amifostine Mucosal Protection in Patients With Favorable Performance Inoperable Stage II, IIIA, or IIIB Non-Small Cell Lung Cancer Receiving Sequential Induction and Concurrent Hyperfractioned Radiotherapy With Paclitaxel and Carboplatin.

Chairperson: Benjamin Movsas. Telephone: 215-728-5304. Lead organization: Radiation Therapy Oncology Group. Age range: 18 and over.

RTOG-9714, NCI-P97-0124, NCCTG-R9714 Phase III Randomized Study of Palliative Radiation Therapy for Bone Metastases From Breast or Prostate Cancer.

Chairperson: William F. Hartsell. Telephone: 708-723-8030. Lead or-ganization: Radiation Therapy Oncology Group. Age range: 18 and over.

CCCWFU-97194, NCI-P95-0064 Phase III Randomized, Double-blind Study of Warfarin vs Placebo for Chemoprevention of Thrombosis in Central Venous Access Catheters in Cancer Patients.

Chairperson: Willard Abe Andes. Telephone: 910-716-9046. Lead organization: Comprehensive Cancer Center of Wake Forest University Baptist Medical Center. Age range: over 18.

SWS-SAKK-90/95, EU-97035 Phase III Randomized Study Comparing Granisetron versus Metoclopramide in Combination With Dexamethasone in the Prophylaxis of Chemotherapy-Induced Delayed Emesis.

Chairperson: Matti Aapro. Telephone: 41-22-366-9134 (Milano, Italy). Lead organization: Swiss Institute for Applied Cancer Research. Age range: 18 and over.

CLB-9170, NCI-P93-0046 Phase III Randomized Study Comparing Continued Hospital Care vs Early Discharge Therapy of Low-Risk Patients With Fever and Neutropenia.

Chairperson: James A. Talcott. Telephone: 617-724-5451. Lead organization: Cancer and Leukemia Group B. Age range: 18 and over.

E-1Z93, NCI-P94-0059 Phase III Randomized Study of Sucralfate Suspension vs Topical Vitamin E for the Treatment of Chemotherapy-Induced Mucositis.

Chairperson: Lisa A. Stucky-Marshall. Telephone: 312-908-6443. Lead organization: Eastern Cooperative Oncology Group. Age range: 18 and over.

SCCC-92110, NCI-V93-0288 Phase II/III Pilot Study of Fluconazole as Prophylaxis for Mucositis/ Thrush in Patients Undergoing Radiotherapy for Head and Neck Cancer.

Chairperson: Arnold M. Markoe. Telephone: 305-243-4319. Lead organization: Sylvester Cancer Center. Age range: over 21.

NCI-92-C-0134B, NCI-T92-0022N Study of CPDG2 and Thymidine for the Management of Patients With MTX Toxicity Secondary to Renal Dysfunction.

Chairman: Peter C. Adamson. Telephone: 301-496-7387. Lead organization: Division of Clinical Sciences. Age range: any age.

RTOG-9604, NCI-P97-0122 Study to Validate the SOMA (Subjective, Objective, Management) Scale for Late Effects of Normal Tissue after Radiation Therapy for Head and Neck Cancer.

Chairperson: Philip Rubin. Telephone: 716-275-2229. Lead organization: Radiation Therapy Oncology Group. Age range: not specified.

URCC-U1996, NCI-P97-0088 Phase III Prevalence Study of Paroxetine Hydrochloride for Fatigue in Cancer Patients Receiving Chemotherapy.

Chairperson: Jane T. Hickok. Telephone: 716-275-5513. Lead organization: University of Rochester Cancer Center. Age range: 18 and over.

E-2Z96, NCI-P98-0130 Phase III Randomized Study of Methylphenidate for Alleviation of Fatigue and Lethargy in Patients With Malignant Melanoma Receiving Interferon Alfa.

Chairman: Robert L. Comis. Telephone: 215-893-6440. Lead organization: Eastern Cooperative Oncology Group. Age range: 18 and over.

RPCI-DS-97-10, NCI-G98-1394, ORTHO-PR-96-27-004 Phase III Randomized Study of Epoetin Alfa versus Placebo in Anemic Patients Receiving Chemotherapy for Stage IV Metastatic Breast Cancer.

Chairperson: Ellis G. Levine. Telephone: 716-845-8547. Lead organization: Roswell Park Cancer Institute. Age range: 18-80.

NCCTG-959255, NCI-P96-0075 Phase III Randomized, Double-blind Study of Megestrol vs Dronabinol vs Both in Patients With Cancer-Related Anorexia and Cachexia.

Chairperson: Charles L. Loprinzi. Telephone: 507-284-8964. Lead organization: North Central Cancer Treatment Group. Age range: 18 and over.

CAN-OTT-9605, NCI-V96-1084 Randomized Study of the Effect of Exercise During Adjuvant Therapy on Quality of Life in Women With Stage I/II Breast Cancer.

Chairman: Roanne Segal. Telephone: 613-247-6803. Lead organization: Ottawa Regional Cancer Centre - Civic Campus. Age range: 30 and over.

CAN-NCIC-SC16 Phase III Randomized Study of Oral Pilocarpine for Patients With Opioid-Induced Dry Mouth.

Chairman: David Warr. Telephone: 416-946-2260. Lead organization: NCIC-Clinical Trials Group. Age range: 16 and over.

EORTC-15961/40973 International Field Study of the Reliability and Validity of the Quality-of-Life Questionnaire EORTC QLQ-C30 and the Disease-Specific Module EORTC QLQ-OES-24 in Patients With Esophageal Cancer.

Chairman: Jane Blazeby. Telephone: +117 923 00 00 (England). Lead organization: EORTC Quality of Life Study Group. Age range: any age.

CLB-9870 Companion Study to Evaluate Quality of Life and Cost of Treatment in Patients With Esophageal Cancer Enrolled on CALGB C9781.

Chairman: David G. Pfister. Telephone: 212-639-7477. Lead organization: Cancer and Leukemia Group B. Age range: 18 and over.

GOCS-08-BR-95-III, NCI-F95-0036 Phase III Randomized Study of Neoadjuvant Fluorouracil/Doxorubicin/Cyclophosphamide (FAC) vs Cyclophosphamide/Methotrexate/Fluorouracil (CMF) for Stage III Breast Cancer, With Quality of Life Assessed in Patients Converted to Conservative Surgery vs Those Who Are Not.

Chairman: Bernardo A. Leone. Telephone: 54-99-485247 (Argentina). Lead organization: Grupo Oncologico Cooperativo del Sur. Age range: pre/postmenopausal.

NCCTG-979253, NCI-P98-0133 Phase III Randomized Study of Epoetin Alfa in Anemic Patients With Advanced Cancer Undergoing Chemotherapy.

Chairman: Michael J. O’Connell. Telephone: 507-266-4997. Lead organization: North Central Cancer Treatment Group. Age range: 18 and over.

CAN-NCIC-SC14 Phase III Randomized Study of Theophylline for the Treatment of Dyspnea in Cancer Patients.

Chairman: Deborah J. Dudgeon. Telephone: 613-545-6000, ext 7694. Lead organization: NCIC-Clinical Trials Group. Age range: 16 and over.

SWOG-9208, CLB-9497 Companion Protocol to Evaluate Quality of Life and Health Status in Patients With Stage I/IIA Hodgkin’s Disease Simultaneously Enrolled on SWOG-9133 or CLB-9391.

Chairman: Patricia A. Ganz. Telephone: 310-206-1404. Lead organization: Southwest Oncology Group. Age range: 18 and over.

MSKCC-97125, NCI-G98-1436, ORTHO-MSKCC-97125, ORTHO-PR-96-27-031 Phase III Randomized Study of the Effects of Epoetin Alfa on Hemoglobin, Symptoms Distress, and Quality of Life During Chemotherapy in Lymphoma Patients With Mild or Moderate Anemia.

Chairman: David J. Straus. Telephone: 212-639-8365. Lead organization: Memorial Sloan-Kettering Cancer Center. Age range: 18 and over.

Legend for Abbreviations:

CAN-NCIC = National Cancer Institute of Canada

CCCWFU = Comprehensive Cancer Center of Wake Forest University

CLB = Cancer & Leukemia Group B

CTI = Cell Therapeutics, Inc.

DIATIDE = Diatide, Inc.

E = Eastern Cooperative Oncology Group

EORTC = European Organization for Research on Treatment of Cancer

EU = European Voluntary Protocol

GOCS = Grupo Oncologico Cooperativo del Sur

MSKCC = Memorial Sloan-Kettering Cancer Center

NCCTG = North Central Cancer Treatment Group

NCI = National Cancer Institute

ORTHO = Ortho Biotech, Inc.

RPCI = Roswell Park Cancer Institute

RTOG = Radiation Therapy Oncology Group

SCCC = Sylvester Comprehensive Cancer Center

SWOG = Southwest Oncology Group

SWS-SAKK = Swiss Group for Clinical Cancer Research

UCMC = University of Cincinnati

URCC = University of Rochester Cancer Center


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