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Protocol Fast Facts
NSABP, SWOG, CALGB& RTOG

NSABP, SWOG & CALGB Click here for RTOG
•  Breast Protocols: Neoadjuvant
•  Breast Protocols: Stages 0-II
•  Breast Protocols: Stages I-IIIA
•  Breast Protocols: Locally
Advanced/Recurrent Metastatic
•  Breast Protocols: Surgical
•  Cancer Control/
Symptom Management
•  GI Protocols: Colon-Rectal
GU Protocols: Bladder/UrinaryTract
GU Protocols: Renal
GYN Protocols: Ovary
Head & Neck Protocols
  Lung Protocols: Non-small Cell
  Lung Protocols: Small Cell
  Melanoma Protocols
  Breast Protocols
  CNS Protocols
  GU Protocols: Prostate
  Head & Neck Protocols
  Lung Protocols: Non-Small Cell
  Lung Protocols: Small Cell
  Miscellaneous Protocols

BREAST PROTOCOLS: Neoadjuvant

1.  ACOSOG Z1031 - Accrual suspended pending IRB review of Amend #7
Neoadjuvant Hormonal Therapy

Eligibility: clinical stage T2-T4c, any N, M0; ER+ tumor with Allred score of 6, 7 or 8; postmenopausal; surgical resection is the goal; performance status 0-2: RX: Exemestane 25 mg/day vs Letrozole 2.5 mg/day vs Anastrozole 1
mg/day. Pts will have breast biopsy at 2-4 wks for Ki67 testing. Pts with Ki67 of </=10 will continue AI for total of 16-18wks followed by surgery. Pts with Ki67 >10 will have chemo or immediate surgery. (NO DRUG SUPPLIED)

2. CALGB 40601
Clinical Stage II-III; HER2 Positive

Eligibility: breast tumor must be at least 1 cm by clinical  or radiographic msmt; multicentric or bilateral dz is OK; no prior treatment for this cancer; performance status 0-1; men OK: Rx: Taxol/Herceptin weekly + Lapatinib po qd x 16 weeks versus Taxol/Herceptin weekly x 16 weeks versus Taxol weekly + Lapatinib po qd x 16 weeks. (LAPATINIB SUPPLIED)

3. CALGB 40603
Clinical Stage IIA-IIIA; Triple Negative (ER/PR/HER2)

Eligibility: histologic dx by core or incisional bx; measurable dz >/= 1 cm; pt must agree to pretreatment research biopsies; no prior chemo, hormonal therapy or RT for this cancer;  performance status 0-1: Rx: Paclitaxel à ddAC +/- Bevacizumab vs Paclitaxel + Carboplatin à ddAC +/- Bevacizumab (BEVACIZUMAB/PLACEBO SUPPLIED) 

4. SWOG 0800
HER2-negative Inflammatory or Locally Advanced

Eligibility: women with stage IIIb or stage IIIa/IIb unresectable dz; no prior chemo, biologic therapies or RT for breast cancer within 5 yrs; prior hormonal Rx okay but must D/C 7 days prior to protocol Rx; performance status 0-2: Rx: Bev + nab-paclitaxel x 12 wks --> AC + PEG-G q 2 wks x 6 versus Nab-paclitaxel q wk x 12 --> AC + PEG-G q 2 wks x 6 versus AC + PEG-G q 2 wks x 6 --> nabj-paclitaxel x 12 wks. (BEVACIZUMAB AND NAB-PACLITAXEL SUPPLIED)

BREAST PROTOCOLS: Stages 0-II

1.  NSABP B-39: (RTOG 0413)
Stages 0 - II Treated by Lumpectomy (Closed to the following low risk groups: women >/= 50 yrs with DCIS only or with node negative, hormone positive invasive cancer)
Eligibility: tumor < 3.0 cm; no more than 3 positive nodes; no bilateral dz; must enroll prior to start of adj chemo and within 42 days of last surgery for breast cancer: RX: Whole breast irradiation versus partial breast irradiation (approved for use at Doctors Medical Center and East Bay Radiation Oncology Center only) .

2.  NSABP B-43
HER2-positive DCIS

Eligibility: tumors must be HER2 positive by centralized testing (pts must agree to centralized HER2 testing pre-entry); tumor completely removed by lumpectomy; axillary staging not required but if done must be node-negative; enroll </= 120 post-op; no multicentric disease: Rx: RT +/- Trastuzumab (TRASTUZUMAB SUPPLIED)

BREAST PROTOCOLS: Stages I-III

1.  CTSU E5103
Node Positive and High-risk Node Negative 

Eligibility: node pos or node neg with one of the following- ER neg tumor >/= 1 cm; or ER pos tumor >/= 5 cm; or ER pos tumor between 1 & 5 cm with recurrence score >/= 11; must be </= 84 days post-op; HER+ not eligible; men OK: RX: AC + placebo > T + placebo versus AC + Bev > T + Bev versus AC + Bev > T + Bev > Bev. (BEV/PLACEBO SUPPLIED)

2. CTSU MA.32
Post Surgery and/or Chemotherapy

Eligibility: invasive breast cancer completely resected within 12 months of enrollment; pT1-3; pN0-3; M0 (see protocol section 5.1.4 for further details); completed surgery and/or chemo at least 4 wks prior to enrollment; performance status 0-2; age < 75 and 5 yr life expectancy: Rx: Metformin 850 mg po bid x 5 years versus identical placebo (DRUG SUPPLIED)

3.  CTSU N063D (Design 2B only)
HER-2 Positive 

Eligibility: Node positive or node negative if tumor >/= 1.0 cm; sentinel node dissection is adequate if negative; performance status </= 1; must enroll within 8 wks of definitive surgery; no bilateral breast cancer; men okay: Rx: Docetaxel/Carbo (6 cycles) + Herceptin (52 wks) VS Docetaxel/Carbo (6 cycles) + Lapatinib (52 wks) VS Docetaxel/Carbo (6 cycles) + concurrent Herceptin (18 wks) followed by Lapatinib (28 wks) VS Docetaxel/Carbo (6 cycles) + Herceptin & Lapatinib (52 wks) (LAPATINIB SUPPLIED)

4. SWOG 0221
Node Positive and High-risk Node Negative (see protocol for risk criteria)

Eligibility: Stage I-III, synchronous bilat dz OK(w/in 1 month); T4 tumors not OK; HER2-positive tumors OK; men OK; no CHF or active angina; enroll w/in 84 days of surgery: RX: AC + PEG-G x 6 followed by q 2 wk T + PEG-G x 6 versus AC + PEG-G x 6 followed by weekly T x 12 versus AC + G x15 followed by q 2 wk T + PEG-G x 6 versus AC + G x15 followed by weekly T x 12. (G-CSF SUPPLIED- contact Amgen for financial assistance with PEG-G if needed)

BREAST PROTOCOLS: Locally Advanced/Recurrent/Metastatic

1. CALGB 40502
Stage IV or IIIB not Amenable to Local Therapy

Eligibility: measurable disease; no prior chemo for stg IV or IIIB disease; prior neoadj, adj Rx allowed; prior bevacizumab allowed; HER2 pos pts must have rec'd Herceptin or Lapatinib; ECOG performance status 0-1; men OK: Rx: Paclitaxel + bevacizumab vs Nab-paclitaxel + bevacizumab vs Ixabepilone + bevacizumab. (NAB-PACLITAXEL, BEVACIZUMAB AND IXABEPILONE SUPPLIED)

2. CALGB 40503
Unresectable Stage IIIB or Stage IV
Eligibility: ER and/or PR positive; measurable or non-measurable dz; no prior chemo for met dz; no hormonal Rx for met dz unless initiated within 4 wks of registration; prior adj/neoadj chemo and/or hormonal Rx allowed; performance status </= 1: RX: Endocrine therapy (Tam or Letrozole) plus Bevacizumab or Placebo q 21 days (ovarian suppression is required for premenopausal pts). (BEVACIZUMAB/PLACEBO & LETROZOLE SUPPLIED)

3. CTSU N0733
HER2-positive and Previously Treated with Trastuzumab

Eligibility:locally adv (T4 & stg IIIb or IIIc) or metastatic dz; only 1 prior chemo regimen containing Trastuzumab with an anthracycline and/or a taxane in the adj or adv/met setting; unlimited prior hormonal Rx okay; measurable dz by RECIST; performance status 0 - 2; men okay: Rx: Capecitabine and Lapatinib +/- IMC-A12. (IMC-A12 and LAPATINIB SUPPLIED)

4.  SWOG 0622
Stage IV, Bone Metastasis Predominant DZ

Eligibility: the number of bone mets must be = or > than the number of non-bone, measurable lesions; if nonmeasurable dz only, pt must have rising CA 15-3 or CA 27-29; 1 prior chemo for met dz allowed; if ER/PR+, must have had at least 1 hormonal Rx for met dz; men OK: RX: Dasatinib, 100 mg PO QD versus Dasatinib, 70 mg PO BID. (DASATINIB SUPPLIED)

5. SWOG 0800
HER2-negative Inflammatory or Locally Advanced

Eligibility: women with stage IIIb or stage IIIa/IIb unresectable dz; no prior chemo, biologic therapies or RT for breast cancer within 5 yrs; prior hormonal Rx okay but must D/C 7 days prior to protocol Rx; performance status 0-2: Rx: Bev + nab-paclitaxel x 12 wks --> AC + PEG-G q 2 wks x 6 versus Nab-paclitaxel q wk x 12 --> AC + PEG-G q 2 wks x 6 versus AC + PEG-G q 2 wks x 6 --> nabj-paclitaxel x 12 wks. (BEVACIZUMAB AND NAB-PACLITAXEL SUPPLIED)

BREAST PROTOCOLS: Surgical

1.  ACOSOG Z1071
Node Positive Breast Cancer (T1-4, N1-2, M0)

Eligibility: positive FNA or core bx of axillary node (prior to neoadj Rx); planned or completed neoadj chemo; no prior ipsilateral axillary surgery or/excisional biopsy or treatment of hidradenitis; performance status 0-1: Surgery:  SLN and ALND

CANCER CONTROL/SYMPTOM MANAGEMENT PROTOCOLS

1. CALGB 170601
Treatment of Chemo Induced Peripheral Neuropathy (PN)

Eligibility: >/= grade 2 peripheral sensory neuropathy (interfering with function); past Rx with taxol or oxaliplatin (not both); >/= 3 months since completion of Rx; no pre-existing PN; no use of vitamin supplements above recommended daily allowances; no antidepressants or anticonvulsants; no warfarin or heparin; stable doses of analgesics for PN okay: Rx: duloxetine/placebo (DULOXETINE/PLACEBO SUPPLIED)

2.  CALGB 70305
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 </= 17 inches measured pre-op and, if applicable, pre neoadj RX: step 2: full axillary node dissection including 10 or more nodes. Intervention: LEAP (lymphedema education with a comprehensive exercise program).

3.  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)

4. HLMCC 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)

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. 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)

7. SWOG 0715
Prevention of Taxane Induced Neuropathy

Eligibility: women with resected stg I-IIIa breast cancer; plans to receive one of 5 std taxane regimens; concurrent biologic therapy OK; other therapeutic trials OK; performance status 0-2: RX: Acetyl-L Carnitine (ALC) or Placebo po daily x 24 wks (ALC/PLACEBO SUPPLIED)

GI PROTOCOLS: Colo-Rectal

1. CALGB 80405
Locally Advanced (unresectable) or Metastatic Disease
Eligibility: Must have wild type K-ras gene as determined by central lab. No prior treatment for advanced dz; no prior Bevacizumab or Cetuximab; no history of significant bleeding ; no pleural effusion or grade 2 dyspnea; no CNS metastases; no periperal neuropathy =/> grade 2: RX: FOLFOX or FOLFIRI (physician's choice) + Bevacizumab versus FOLFOX or FORFIRI + Cetuximab versus FOLFOX or FOLFIRI + Bevacizumab and Cetuximab. (CETUXIMAB SUPPLIED)

2. CALGB 80702
Stage III Completely Resected Adenocarcinoma of the Colon

Eligibility: en bloc resection for tumors adherent to adjacent structures; at least 1 pos node; no evidence of residual nodal dz; synchronous tumors okay; NSAIDs not allowed nor aspirin exceeding 325 mg 3 x per week on average; must begin Rx 21 – 56 days post-op: Rx: FOLFOX  x 12 cycles + Celecoxib/placebo versus FOLFOX x 6 cycles + Celecoxib/placebo  (CELECOXIB/PLACEBO SUPPLIED)

3.  CTSU E5202
Stage II Colon Cancer; High Risk versus Low Risk for Recurrence (must submit tumor block to ECOG to determine risk for recurrence)

Eligibility: T3 or T4, N0, M0; at least 8 nodes evaluated; perforation or complete obstruction not allowed; no history of bleeding, TIA, thromboembolic events, peripheral vascular dz or NYHA Class III/IV cardiac dz; no active GI ulcer  RX: low risk pts are registered to observation only; high risk pts are randomized to FOLFOX +/- Bevacizumab. (BEVACIZUMAB & OXALIPLATIN SUPPLIED)

4. 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)

5.  SWOG 0600
Stage IV Colorectal Cancer; 2nd Line Therapy

Eligibility: pts must have progressed on 1st line Rx with bevacizumab + FOLFOX, OPTIMOX or XELOX; progression must be within 90 days of last dose of bevacizumab; measurable or non-measurable dz;  no prior irinotecan, cetuximab or other VEGF/EGFR targeting agents; prior RT and/or surgery allowed:  RX: FOLFIRI or irinotecan + cetuximab versus FOLFIRI or irinotecan + cetuximab + lower dose bevacizumab versus FOLFIRI or irinotecan + cetuximab + higher dose bevacizumab. (BEVACIZUMAB & CETUXIMAB SUPPLIED)

GU PROTOCOLS: Bladder/Urinary Tract

1. CALGB 90601
Progressive, Metastatic or Locally Advanced Transitional Cell ca of the Urinary Tract

Eligibility: T4b, N2, N3 or M1 disease of bladder, ureter, renal pelvis, prostate or urethra; prior (neo)adj chemo okay if >/= 1 year to progression; no prior systemic combination chemo for metastatic dz; no prior angiogenesis inhibitors; no known brain mets; no CHF: Rx: Gencitabine/Cisplatin x 6 cycles (max) + Bevacizumab/placebo until dz progression. (BEVACIZUMAB/PLACEBO SUPPLIED)

GU PROTOCOLS: Renal

1.  CTSU E2804
Advanced Renal Cell; Clear Cell Variant with < 25% Other Histologies

Eligibility: measurable metastatic disease not curable by std RT or surgery; no CNS disease; 1 prior immunotherapy regimen for advanced dz allowed; no prior anti-angiogenic therapy; prior RT allowed; Rx: Bevacizumab versus Bevacizumab + Temsirolimus versus Bevacizumab + Sorafenib versus Temsirolimus + Sorafenib. (ALL 3 DRUGS SUPPLIED)

GYN PROTOCOLS: Ovary

1. SWOG 0904
Recurrent, Refractory, Progressive/Persistent Disease

Eligibility: epithelial ovarian, fallopian tube or primary peritoneal cancer; measurable or non-measurable dz; 1 prior platinum-based regimen for primary dz required; no anti-VEGF therapy or vandetanib; chemo for advanced dz okay but no docetaxel or non-cytotoxic therapy (except hormone therapy): Rx: Docetaxel + concurrent Vandetanib VS Docetaxel followed by Vandetanib at time of dz progression.

HEAD & NECK PROTOCOLS

1.  CTSU E1305
Recurrent or Netastatic Disease

Eligibility: SCC of H&N, any primary; recurrent and incurable by surgery or metastatic; no prior chemo or bio therapy for rec/met dz; 1 prior regimen of induction or adj chem and/or RT with curative intent allowed; must be > 6 months since last chemo and/or RT; palliative RT to H&N allowed but must be > 8 wks since last dose; no prior Bev; no brain mets; Rx: physician choice of Docetaxel/Cisplatin or Cisplatin/5FU; pt then randomized to chemo +/- bevacizumab. (BEVACIZUMAB SUPPLIED)

LUNG PROTOCOLS: Non-small Cell

1.  CALGB 30605
Poor Risk Stage III NSCLC

Eligibility: Unresectable Stage IIIA or IIIB; measurable dz; no prior chemo or RT for NSCLC; performance status = 2 OR performance status 0-1 and >/= 10% wt loss: RX: Abraxane + Carbo X 2 cycles followed by RT + concurrent Erlotinib 150 mg PO QD. (ERLOTINIB & ABRAXANE SUPPLIED)

2. CALGB 30607
Stage IIIB/IV; Maintenance Therapy

Eligibility:  pts must have received 4 cycles platinum based doublet therapy +/- bevacizumab; no evidence of progression; no prior adj chemo for stg I-III resected dz or combined modality Rx for stage III NSCLC; Rx:  Sunitinib, 37.5 mg po daily versus Placebo.  (SUNITINIB/PLACEBO SUPPLIED)

3.  CALGB 30704
Second Line Treatment of Advanced NSCLC

Eligibility: stage IIIB or IV with evidence of progression during/following 1st line Rx; only one prior regimen for advance dz; no prior VEGFR inhibitors; no prior pemetrexed; measurable or non-measurable dz; performance status 0 -1; Rx: Pemetrexed versus Sunitinib versus Pemetrexed + Sunitinib. (SUNITINIB SUPPLIED)

4.  CTSU E1505
Completely Resected NSCLC

Eligibility: Stage IB – IIIA (If IB, tumor >/= 4 cm); wedge resection or segmentectomy NOT allowed; mediastinal lymph node sampling expected; no prior chemo; performance status 0-1; 6-12 weeks post-op: RX: One of 3 chemo regimens +/- Bevacizumab (Investigator may choose Cisplat/Vinorelbine or Cisplat/docetaxel or Cisplat/gemcitabine). (BEVACIZUMAB SUPPLIED)

5.  SWOG 0819
Stage IV Newly Diagnosed or Recurrent

Eligibility:  measurable or non-measurable dz; performance status 0-1; no prior chemo, cetuximab, gefitinib, erlotinib or agents that target EGFR pathway; no VEGF related agents; no chimerized or muring monoclonal antibody therapy; nodules in an ipsilateral non-primary lobe with no other M1 dz will not be considered stage IV: Rx: Chemo +/- Bevacizumab versus Chemo with Cetuximab +/- Bevacizumab (CETUXIMAB SUPPLIED)

LUNG PROTOCOLS: Small Cell

1. CALGB 30504
Untreated Extensive Stage Disease

Eligibility: must have measurable disease; no prior chemo for SCLC; prior RT okay; performance status 0 - 2; no brain mets; Rx: Cisplatin or Carbo + Etoposide q  21 days for up to 6 cycles. After a min of 4 cycles patients with responding or stable dz are randomized to sunitinib/placebo.  Those on placebo crossover to Sunitinib at progression.
(SUNITINIB/PLACEBO & SUNITINIB OPEN LABEL SUPPLIED)

2. CALGB 30610
Limited Stage

Eligibility: No prior resection; no prior chemo or RT for SCLC; no prior thoracic RT; measurable or non-measurable dz; performance status 0-2; RX: Cisplatin/Etoposide X 4 cycles plus one of three radiotherapy regimens (3 arm study).  (NO DRUG SUPPLIED)

MELANOMA PROTOCOLS

2. SWOG 0826
Stage IV Disease of Cutaneous or Mucosal Origin

Eligibility: measurable or non-measurable dz; unknown primary okay; performance status 0-1; up to 1 prior systemic Rx for stage IV dz; any number of adj system therapies allowed; prior RT and prior surgery allowed: Rx: SCH 727965 iv q 21 days (SCH 727965 SUPPLIED)

 

These Protocols are Approved for Use at the Following Hospitals
Alameda County Medical Center
Alta Bates Summit Medical Center
Contra Costa Regional Medical Center
Doctors Medical Center
El Camino Hospital

Abbreviations
ACOSOG = American College of Surgeons Oncology Group
CALGB = Cancer and Leukemia Group B
CCCWFU = Comprehensive Cancer Center at Wake Forest University
CTSU = Cancer Trials Support Unit
ECOG = Eastern Cooperative Oncology Group
HLMCC = H. Lee Moffitt Cancer Center
IBCSG = International Breast Cancer Study Group
NCI = National Cancer Institute
NSABP = National Surgical Adjunct Breast and Bowel Project
PACCT = Program for the Assessment of Clinical Cancer Tests
RTOG = Radiation Therapy Oncology Group
SWOG = Southwest Oncology Group

REVISED 8/25/10

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		Suite 301, Oakland, California 94609-3305,
		Tel (510) 465-2242, Fax (510) 465-8588