Ongoing Clinical Protocols at Ochsner

Bone Metastases Other Than Breast or Prostate Cancer or Multiple Myeloma

Sponsor: Schering-Plough Research Institute

Contact: Cindy Rittenberg, RN 504 842-3708

Title: Protocol CGP-4244603-011: A randomized, double-blind, placebo-controlled, multicenter trial to evaluate the safety and efficacy of Zoledronate (4 and 8 mg) administered intravenously as an adjuvant to anticancer therapy to patients with any cancer with bone metastases other than breast cancer, multiple myeloma, or prostate cancer.

Inclusion Criteria:

• Diagnosis of cancer other than breast, prostate, or multiple myeloma

• Objective evidence of metastatic bone disease within 6 weeks of trial entry

• No previous treatment with a biphosphonate

Study Design: Patients are randomized to receive by rapid iv infusion Zoledronate 4 mg, Zoledronate 8 mg, or placebo. Patients may receive concomitant standard anti-neoplastic radiation or cytokine colony stimulating therapy.

Breast Cancer Prevention

Sponsor: Eastern Cooperative Oncology Group

Contact: Carl G. Kardinal, MD 504 842-3708

Chris D'Arcangelo, RN 504 842-3708

Title: Protocol E1496: Randomized phase III study in low grade lymphoma comparing cyclophosphamide/fludarabine to standard therapy followed by maintenance anti-CD20 antibody.

Inclusion Criteria:

• Stage III-IV low grade non-Hodgkin's lymphoma

• Must have at least one objective measurable disease parameter IDEC-C2B8 (Rituximab) provided

Breast Cancer Prevention

Sponsor: National Surgical Adjuvant Breast and Bowel Project

Contact: Carl G. Kardinal, MD

Kate Rodger, RN 504 842-3708

Title: Study of tamoxifen and raloxifene for the prevention of breast cancer.

Inclusion Criteria:

Postmenopausal women age 35 or older

Must be risk eligible determined by the Gail Model:

• Family history; mother, sister(s), daughter(s)

• Age

• Nulliparous

• Having a first child after age 30

• Early menarche

• History of benign breast disease requiring biopsies

• LCIS or atypical hyperplasia

Breast Cancer

Sponsor: National Surgical Adjuvant Breast and Bowel Project

Contact: Carl G. Kardinal, MD 504 842-3708

Cindy Rittenberg, RN 504 842-3708

Title: A 3-arm randomized trial to compare adjuvant Adriamycin and cyclophosphamide followed by Taxotere; Adriamycin and Taxotere; and Adriamycin, Taxotere, and cyclophosphamide in breast cancer patients with positive axillary lymph nodes.

Inclusion Criteria:

• Tumor confined to breast and ipsilateral axilla on clinical exam (T1–3, N0–1, M0)

• At least 1 positive axillary lymph node on path exam

• Time from initial Dx to randomization < 63 days

• L VEF (MUGA or echo) > lower limit of normal

Taxotere is provided.

Liver Transplant

Sponsor: SangStat

Contact: Dr. James Eason 504 842-5763

Dr. George Loss

Title: Randomized prospective trial using thymoglobulin induction in liver transplant recipients to eliminate steroid usage.

Inclusion Criteria: All adult liver transplant candidates giving informed consent.

Melanoma

Sponsor: Sunbelt Melanoma Trial (Cooperative Group of Surgical Oncologists)

Contact: George Fuhrman, MD 504 842-4070

Cindy Rittenberg, RN504 842-3708

Title: Sunbelt Melanoma Trial (SMT): A multicenter trial of adjuvant interferon ALFA-2b for melanoma patients with early lymph node metastasis detected by lymphatic mapping and sentinel lymph node biopsy.

Inclusion Criteria:

• Patients with melanoma > 0.76 mm thick or Clark's level III invasion and clinically negative nodes

• The primary cutaneous melanoma must be on the head, neck, trunk, extremity, palm of hand, or sole of foot

• Patients must be between the ages of 18 and 70

• Patients cannot have a wide skin excision prior to randomization and treatment

Myelodysplastic Syndrome

Sponsor: Eastern Cooperative Oncology Group

Contact: Chris D'Arcangelo, RN 504 842-3708

Title: E 1996: Phase III evaluation of EPO with or without G-CSF versus supportive therapy alone in the treatment of myelodysplastic syndromes.

Inclusion Criteria:

• Myelodysplastic syndrome RA, RA-S, or RAEB as defined by the FAB as cooperative groups

• No androgens or steroids within 2 weeks prior to starting treatment

Non-Hodgkin's Lymphoma

Sponsor: Eastern Cooperative Oncology Group

Contact: Carl G. Kardinal, MD 504 842-3708

Chris D'Arcangelo, RN 504 842-3708

Title: Protocol E4492: Phase III trial of CHOP versus CHOP and chimeric anti-CD-20 monoclonal antibody (IDEC-C2B8) in patients 60 years or older with diffuse mixed, diffuse large cell, and immunoblastic large cell histology non-Hodgkin's lymphoma.

Inclusion Criteria:

• Intermediate or high grade non-Hodgkin's lymphoma, B-cell, positive CD20 and/or CD9

• At least one measurable disease parameter

• No prior treatment except corticosteroids

• Pretreatment IgG level greater than 500 mg/dL

IDEC-C2B8 (Rituximab) provided

Ovarian Cancer

Sponsor: Schering-Plough Research

Contact: Richard Kline, MD 504 842-3708

Cindy Rittenberg, RN 504 842-3708

Title: Protocol C98-102: A phase II/III trial of chemotherapy alone versus chemotherapy plus SCH 58500 in newly diagnosed stage III ovarian and primary peritoneal cancer patients with <2 cm residual disease (0–2 cm) following surgery.

Inclusion Criteria:

• Stage III epithelial, ovarian, or primary peritoneal cancer

• Residual disease > 0.5 cm and < 2 cm following cytoreductive surgery

• Mutant or null p53 gene

• Serologically positive for anti-adenovirus antibodies at screening

Study Design: Patient is randomized to receive Taxol/Carbo plus SCH 58500 for cycles 2 through 6 of chemotherapy.

Pancreatic Cancer

Sponsor: SuperGen

Contact: Edwin A. McElroy, Jr., MD 504 842-3708

Cindy Rittenberg, RN 504 842-3708

Title: Protocol RFS 2000-02: Phase III randomized study of RFS 2000 (9-nitro-camptothecin, RFS 2000) versus gemcitabine HCL in chemonaive pancreatic cancer patients.

Inclusion Criteria:

• KPS > 50

• Chemotherapy naïve

Pancreatic Cancer

Sponsor: SuperGen

Contact: Cindy Rittenberg, RN 504 842-3708

Title: Protocol RFS 2000-09: Phase III study of RFS 2000 (9-nitrocamptothecin, 9-NC) versus most appropriate chemotherapy in refractory pancreatic cancer patients.

Inclusion Criteria:

• Patients must have failed or relapsed after receiving at least one prior chemotherapy regimen (other than gemcitabine or 5-FU as a radiation sensitizer as their only chemotherapy)

Study Design: Patients are randomized to receive oral RFS 2000 given daily x5 followed by a 2-day rest, or to the most appropriate chemotherapy available.

Pancreatic Cancer

Sponsor: SuperGen

Contact: Edwin A. McElroy, Jr., MD 504 842-3708

Cindy Rittenberg, RN 504 842-3708

Title: Protocol RFS 2000-06: Phase III randomized study of RFS 2000 (9-nitrocamptothecin, 9-NC) versus 5-fluorouracil (5-FU) in pancreatic cancer patients that have progressive disease following gemcitabine HCL treatment.

Inclusion Criteria:

• KPS > 50

• Must have received gemcitabine and have progressive disease during or following treatment

• Cannot have received any other chemotherapy except gemcitabine

Study Design: Patients will be randomized to either oral RFS 2000 given daily x5 followed by a 2-day rest, or to iv 5-FU given weekly.

Rheumatology

Sponsor: Immunex Corporation

Contact: Dr. William E. Davis 504 842-3920

Title: Immunex protocol 16.0012 – recombinant human tumor necrosis factor receptor fusion protein (TNFR:Fc) vs. methotrexate in rheumatoid arthritis.

Inclusion Criteria:

• Active early RA as duration of disease = 3 years (36 months)

• No prior treatment with methotrexate

Exclusion Criteria:

• Intra-articular, soft tissue, or intra-muscular corticosteroid injection during 4 weeks prior to screening

• Treatment with cyclophosphamide within 6 months prior to screening

• Presence of anti-DNA antibodies at screening or history of anti-cardiolipin antibodies associated with a thrombotic event or recurrent fetal loss syndrome

Rheumatology

Sponsor: University of Connecticut Health Center

Contact: Dr. Robert Quinet 504 842-3920

Title: The national woman arthritis study.

Inclusion Criteria: Women 18–64 with no life-threatening illnesses: cancer, heart disease

Patient paid $100 the first year for participation – a yearly phone interview

Rheumatology

Sponsor: Merck & Co.

Contact: Dr. Leonard Serebro 504 842-3920

Title: A double blind randomized stratified parallel group study to access the incidence of PUBs during chronic treatment with MK-0966 or Naprosyn in patients with rheumatoid arthritis: US cohort.

Inclusion Criteria: Male or female at least 50 years old having rheumatoid arthritis and in good health

Exclusion Criteria: Inflammatory arthritis, history of ulcer or GI bleed or inflammatory bowel disease, active hepatitis, stroke, allergic to acetaminophen or hypersensitive to aspirin, naproxen, or other NSAIDs.

Rheumatology

Sponsor: Merck & Co.

Contact: Dr. Robert Quinet 504 842-3920

Title: A randomized multi-center study to evaluate the tolerability and effectiveness of rofecoxib (MK-0966) 25 mg q.d. vs. naproxen 500 mg b.i.d. in patients with osteoarthritis.

Inclusion Criteria:

• At least 40 years of age

• Osteoarthritis in knee, hip, or spine for >6 months

• History of therapeutic benefit in OA of the knee, hip, hand, or spine with NSAID or acetaminophen use

Exclusion Criteria:

• Diagnosed as American College of Rheumatology Functional Class 4

• Concurrent medical or arthritic disease that could confound or interfere with evaluation of efficacy including inflammatory arthritis

• History of GI malabsorption

• Allergic to naproxen, acetaminophen or hypersensitive to aspirin, ibuprofen, naproxen, or other NSAIDs

Rheumatology

Sponsor: Searle & Co.

Contact: Dr. Robert J. Quinet & Dr. Leonard Serebro 504 842-3920

Title: Clinical protocol for a multi-center double blind parallel group study comparing the incidence of clinically significant upper gastrointestinal adverse events associated with SC-58635, 400 mg b.i.d. to that of diclofenac 75 mg b.i.d. in patients with osteoarthritis or rheumatoid arthritis, IND 48395. The Celecoxib long-term arthritis safety study (class 2).

Inclusion Criteria:

• Legal age of consent

• Documented clinical diagnosis of OA or RA of at least 3 months duration as chronic NSAID therapy

Exclusion Criteria:

• Active malignancy of any type or history of a malignancy

• Diagnosed and treated for esophageal gastric pyloric channel or duodenal ulceration within 30 days prior to the first dose

• Active GI disease

• History of gastric or duodenal surgery or any renal or hepatic dysfunction

• Abnormal screening/laboratory abnormality

• Known hypersensitivity to Cox-2 inhibitors, sulfonamides, or Diclofenac

Rheumatology

Sponsor: School of Public Health and Tropical Medicine at Tulane University Medical Center

Contact: Dr. Leonard Serebro 504 842-3920

Title: Environmental factors in the etiology of fibromyalgia in women.

Inclusion Criteria: Primary diagnosis fibromyalgia

Exclusion Criteria: No other connective tissue disease

All doctor visits, lab work, x-rays, endoscopies, and medication required for any of these particular studies are no charge to the patient.