BREAST PROTOCOLS: Neoadjuvant

1.  ACOSOG Z1031
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  for 16 -18 weeks followed by surgery.  Continue post – op Anastrozole or Tamoxifen X 5 years.  Post-op chemo and/or RT at physician’s discretion.

2. NSABP B-40
Neoadjuvant Chemotherapy
Eligibility: dx by core needle biopsy; tumor palpable and >/= 2.0 cm; tumor cannot be strongly HER2 positive; performance status 0 - 1; LVEF >/= LLN: RX: 6 arm study: Docetaxel  Q 3swks X 4  versus Docetaxel/Capecitabine Q 3 wks X 4 versus Docetaxel/Gemcitabine Q 3 wks X 4 ( each arm +/- Bevacizumab) and each  followed by AC Q 3wks X 4 (+/- Bevacizumab).

BREAST PROTOCOLS: Stages 0-II

1. NSABP B-36
Node Negative Breast Cancer (T1-3, N0, M0)
Sentinel node biopsy OK unless patient has palpable nodes- then axillary dissection is mandatory.  Must enroll with 84 days of definitive surgery.  RX: AC X 4 cycles versus FEC X 6 cycles.

2.  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; 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)

3.  PACCT-1 (TAILORx)
Stage I-II, ER and/or PR Positive, Node-negative
Eligibility: Tumor size 1.1 - 5.0 cm or:  5 mm - 1 cm with unfavorable histologic features; HER2 neg by FISH or IHC; pt agreeable to standard adj chemo and hormonal therapy; pre-register within 84 days post-op; submit tissue for determination of recurrence score (RS) within 3 days of pre-registration: RX:  RS < 11 will be assigned hormonal Rx only; RS > 25 will be assigned Chemo + hormonal Rx; RS 11-25 will be randomized to hormonal Rx only versus Chemo + hormonal Rx.

BREAST PROTOCOLS: Stages I-III

1.  CALGB 40101
High-risk, 0-3 Positive Nodes
Eligibility: If node-negative, tumor must be  > 1 cm or ER or PR negative; < 84 days since last breast surgery; sentinel node dissection is adequate if negative; no prior anthracycline; no prior chemo for this cancer; no more than 4 wks of Tam for this cancer: RX: AC (4 versus 6 cycles) or Taxol (4 versus 6 cycles).

2.  CTSU N063D (ALTTO)
Adequately Resected, HER-2 Positive 
Eligibility: Node positive or node negative if tumor >/= 1.0 cm; performance status </= 1; must have completed at least 4 cycles of anthracycline-based chemo (adj or neoadj); no prior anti HER-2 therapy; If docetaxel is indicated, must be given prior to enrollment (Design 1); If a taxane is indicated rando prior to start (Design 2); RT may be given concurrent with protocol therapy: RX: Design 1: Herceptin Q 3 weeks for 52 weeks: Design 2: Taxol + Herceptin weekly X 12 weeks followed by Herceptin Q 3 weeks for 40 weeks.

3.  IBCSG 24-02 (SOFT)
Premenopausal Women with ER and/or PR Positive Tumors
Eligibility: completely resected breast cancer; pts not receiving chemo must enroll within 12 wks of surgery; pts receiving chemo must enroll within 8 months after last dose of chemo; hormonal therapy allowed up to 8 months after diagnosis: RX: Tamoxifen vs Tamoxifen + ovarian function suppression vs Exemestane + ovarian function suppression.

4. SWOG 0307
Bisphosphonates for Stage I -III
Eligibility: Completely resected primary tumor; pts must receive adjuvant Rx (chemo, hormonal or combo); can be registered prior to, during or up to 8 weeks after chemo; if hormonal Rx only register within 12 weeks of surgery; RX: Zoledronic Acid vs Clodronate vs Ibandronate.

BREAST PROTOCOLS: Locally Advanced/Recurrent/Metastatic

1. CALGB 40302
Postmenopausal Women with ER and/or PR Positive Tumors
Eligibility: At least 1 and up to 2 prior hormone therapies; Tumor expression of HER2 (IHC 1+, 2+ , 3+ levels OR FISH positive OR serum HER@ ECD >/= 15 ng/ml); measurable dz required except for pts with bone mets only; no symptomatic CNS mets: RX: Fulvestrant + Placebo vs Fulvestrant + Lapatanib.

2.  CTSU E1105
Metastatic DZ and/or Chest Wall Recurrence; HER-2 Overexpressing
Eligibility: HER-2 gene amplification by FISH or 3+ result by IHC using Herceptest (DAKO); prior hormone therapy and/or RT for met dz allowed; no prior chemo, herceptin or Bevacizumab for met dz; adj herceptin and/or taxane allowed if > 12 months: RX:  Chemo with Taxol +/- Carbo (investigators choice) + Herceptin + Bevacizumab or placebo.

3.  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: RX: Dasatinib, 100 mg PO QD versus Dasatinib, 70 mg PO BID.

BREAST PROTOCOLS: Miscellaneous

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: Education only versus LEAP (education with a comprehensive exercise program.  (The randomization will be by institution.  BATI has not yet been randomized)

1. NSABP B-42
Post Menopausal Patients Completing 5 Years of Adjuvant Hormonal Therapy
Eligibility: ER and/or PR positive primary breast cancer stage I, II or IIIA; completed 5yrs of treatment with an AI or up to 3 yrs of tamoxifen followed by an AI for a total of 5 yrs; performance status 0-1: RX: Letrozole/placebo once daily for 5 years.

GI PROTOCOLS: Colo-Rectal

1. CALGB 80405
Locally Advanced or Metastatic Disease
Eligibility: 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.

2.  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.

3. CTSU E5204
Stage II or III Rectal Cancer S/P Pre-operative Chemoradiation and Surgery
Eligibility: pts must have rec’d RT dose of 40 – 55.8 Gy; IMRT allowed; see protocol for allowed chemo regimens; participation in NSABP R-04 allowed; complete resection; 28–56 days post-op RX: FOLFOX versus FOLFOX + Bevacizumab.

4. CTSU N0147
Stage III Colon Cancer
Eligibility: tumor resected en bloc within 56 days of enrollment; at least 1 pos lymph node; no evidence of residual nodal disease; performance status 0 - 2; no significant peripheral neuropathy; must agree to submission of blood and tissue samples (tissue from prior surgery):RX:FOLFOX versus FOLFOX + Cetuximab.

5. NSABP R-04
Rectal Cancer: Neoadjuvant
Biopsy confirmed adenocarcinoma.  Clinical stage II or III.  Eligibility:  Measurable disease. Zubrod 0-2. No prior RT or chemo. Arm 1: Pre-op RT + 5-FU followed by Surgery Arm 2: Pre-op RT + Capecitabine followed by Surgery.

6.  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.

GI PROTOCOLS: Esophageal

1.  SWOG 0356
Adenocarcinoma, Clinical Stage II - III
Eligibility: tumor must be in thoracic esophagus (>20 cm from incisors) or GE junction; no regional nodes > 1.5 cm; no prior chemo or RT; no previous resection or attempted resection: RX: Oxaliplation + protracted infusion 5-FU and concurrent RT.

GI PROTOCOLS: Stomach

1. CALGB 80101
Surgically Resected Adenocarcinoma of Stomach or GE Junction
Eligibility: Stages II, IIIA, IIIB or IV if MO. M1 not allowed. No prior chemo or RT. Zubrod 0-2. Documentation of stable weight for 1 week prior to enrollment. RX: 5FU/LV followed by 5FU + RT followed by 5FU/LV versus ECF followed by 5FU +RT followed by ECF.

GU PROTOCOLS: Prostate

1. SWOG 0421
Advanced Hormone Refractory
Eligibility: adenocarcinoma of prostate, any T, any N, M1b; must have evidence of bone mets on bone scan; refractory to hormone Rx; no prior chemo for met dz; prior RT and/or surgery allowed; bisphosphonates permitted; RX: Docetaxel + Atrasentan versus Docetaxel + placebo.

2. SWOG 9346
Prostate Cancer: Stage D2
Can have any number of bony mets. PSA > 10. Treatment: Intermittent androgen deprivation. Injection of Zoladex once q. 4 wks. + Casodex 50 mg per day for 7 months. If PSA normalizes then pt. will be randomized to continuous or intermittent CAD.

GU PROTOCOLS: Renal

1.  CTSU E 2805
Unfavorable Renal Cell Carcinoma
Eligibility: T1b-T4, N0-2, M0 ; no prior treatment other than surgery; no clinically significant cardiovascular dz or uncontrolled HTN; baseline LVEF above LLN; randomize 3-10 weeks post-op: RX: Sunitinib + placebo versus Sorafenib + placebo versus placebo + placebo.

LUNG PROTOCOLS: Non-small Cell

1. CALGB 30406
Stage IIIB with Pleural Effusion or Stage IV Adenocarcinoma (including variants)
Eligibility: histologic documentation of dz (tissue block must be available); non smoker or former light smoker; no prior chemotherapy; no prior therapy tageting HER axis; no uncontrolled CNS mets; performance status 0 - 1: RX: Erlotinib only versus Erlotinib + Paclitaxel/Carboplatin X 6 cycles.

2.  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.

3.  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).

LUNG PROTOCOLS: Small Cell

1. CALGB 30602
Chemo-sensitive, Relapsed SCLC
Eligibility: dz progression > 90 days after receiving first-line platinum-based chemo; no more than 1 prior chemo regimen; no prior dasatinib or similar compounds; no brain mets; performance status 0 - 1: RX: Dasatinib 100 mg PO BID.

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). 

LYMPHOMA & HODGKIN'S DISEASE PROTOCOLS

1. SWOG 0520
Relapsed/refractory B-cell lymphoma
Eligibility: relapsed or refractory B-cell lymphoma with aggressive histology of the following subtypes- diffuse lg cell, high-grade Burkitt's or Burkitt's-like, or primary mediastinal; bidimensionally measurable dz; may have up to 3 prior chemo regimens including BMT; no CNS involvement; RX: PDX101 IV over 30 min days 1-5 Q 21 days.

MELANOMA PROTOCOLS

1. CTSU E2603
Unresectable Locally Advanced or Stage IV
Eligibility: prior immunotherapy OK; prior RT OK; no prior chemo or inhibitors of Ras, Raf or MEK; performance status 0-1; no brain mets; no ocular melanoma: RX: Carbo, Taxol + BAY 43-9006 vs Carbo, Taxol + placebo.

SYMPTOM MANAGEMENT PROTOCOLS

1. HLMCC 0501
Stress Management for Chemotherapy Patients
Eligibility: new diagnosis of cancer; scheduled to receive at least 4 cycles of chemo; no concurrent RT; no severe depression: RX: Usual care only versus Stress Mgmt Training kit + usual care

These Protocols are Approved for Use at the Following Hospitals
Alameda County Medical Center
Alta Bates Summit Medical Center
Eden Medical Center
Doctors Medical Center
St. Rose Hospital
ValleyCare Health Systems

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
RTOG = Radiation Therapy Oncology Group
SWOG = Southwest Oncology Group

REVISED 4/7/08