Clinical Trials – Cancer Control and Symptom Management

Clinical Trials – Cancer Control and Symptom Management

Clinical Trials – Cancer Control and Symptom Management Protocols

1. CALGB 70305 (limited available space)
Prevention of Lymphedema
Eligibility- step 1: Newly diagnosed clinical stage I-III breast cancer; no hx LCIS, DCIS or invasive breast cancer; planned neoadj Rx is okay; arm circumference 2. CALGB 70604
Zoledronic Acid for Bone Metastases
Eligibility: adenocarcinoma of breast or prostate; multiple myeloma; at least 1 bone met by radiographic imaging; no brain mets; no prior IV bisphosphonate; no prior radiopharmaceuticals; no current investigational agents; performance status 0-2: RX: Zoledronic acid q 4 weeks versus q 12 weeks. (NO DRUG SUPPLIED) Companion study: SWOG S0702

3. CALGB 70806
Vitamin D and Breast Cancer Biomarkers
Eligibility: premenopausal women /= 25% (BIRAD-2 scattered fibroglandular densities or greater); no prior breast or ovarian cancer or DCIS; no HRT, tamoxifen or raloxifene; breast implants or breast reduction not eligible; no vitamin D above 400 IU/day: Rx: Vitamin D 2000 IU/day x 12 months versus placebo (VITAMIN D/PLACEBO PROVIDED)

4. NSABP DMP-1:
Evaluate Decision Making for Women at Increased Risk for Breast Cancer
Eligibility: Identified by physician to be at increased risk for breast cancer and will discuss use of SERMs for risk reduction; Female; Age > 35; English speaking; No prior breast cancer, DCIS or LCIS; No participation in other cancer or osteoporosis prevention studies; No hx of tamoxifen, raloxifene or other SERM therapy. Evaluations: Counseling Session for potential SERM use: (study enrollment) followed by Questionnaire 1 completion; At 3 months or 6 months: Questionniare 2 completion.

5. NSABP P-5
Polyp prevention in Pts with Resected Colon Cancer
Eligibility: completely resected stg I or II adenoca of the colon; must enroll within 1 year of surgery; performance status 0 or 1; hyperlipidemia with indication for statin therapy not allowed; no familial adenomatous polyposis, malabsorption syndrome, ulcerative colitis or inflammatory bowel disease: Rx: Rosuvastatin 10 mg po qd x 5 yrs VS placebo
(DRUG SUPPLIED)

6. SCUSF 0806
Reduction of Cardiotoxicity in Pts Receiving (Neo)Adjuvant Herceptin
Eligibility: female pts diagnosed with HER2-pos breast cancer; scheduled to received (neo)adjuvant Herceptin; LVEF >/= 50%; no prior Herceptin or anthracycline; no ACE inhibitors, beta blockers or digoxin: Rx: Lisinopril 10 mg VS Coreg CR 10 mg VS placebo (DRUGS PROVIDED)

7. SWOG 0702
ONJ Associated with Zoledronic Acid Treatment
Eligibility: bone metastases from multiple myeloma or solid tumor for which IV bisphosphonate treatment is indicated; plans to receive Zoledronic acid w/in 30 days; prior oral bisphosphonate OK; prior IV bisphos for bone mets allowed w/in 90 days of rando; 3 prior doses of IV bisphos w/in 3 yrs allowed for low bone mass; no prior RT to maxillofacial area; no preexisting ONJ; performance status 0-3: Intervention: dental evaluation q 6 mos. (NO DRUG SUPPLIED) Companion study: CALGB 70604

8. SWOG S0927
Control AI-induced pain/stiffness in early stage Breast CA
Eligibility: Postmenopausal women dx invasive breast cancer stage I-III; ER/PR positive; Taking AI: Arimidex, Femara or Aromasin for at least past 90 days; qualified degree (at least 5) of worst pain/stiffness since beginning AI therapy; Performance status 0-2; ability to complete questionnaires in English; not taking anticoagulation, narcotic, topical analgesic medication; blood/urine specimen collection required. RX: Omega-3-Fatty Acid x 24 wks versus identical Placebo x 24 wks. (DRUG SUPPLIED).

Abbreviations:
CALGB = Cancer and Leukemia Group B
CTSU = Cancer Trials Support Unit
ECOG = Eastern Cooperative Oncology Group
NCI = National Cancer Institute
NSABP = National Surgical Adjunct Breast and Bowel Project
RTOG = Radiation Therapy Oncology Group
SCUSF = SunCoast CCOP Research Base
SWOG = Southwest Oncology Group
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