Sccc Monthly Mail

SCCC MONTHLY MAIL

TO: SCCC Contact Person

FROM: SCCC Operations Office

Belenda Slate, BAS, CCRP

DATE: July 26, 2010

Listed below in research base format, you will find the SCCC semi-monthly approved protocol activity. Please update your protocol books and circulate the applicable items to your community and to your local IRB. If you have any questions or comments please contact me at 336/777-3092 or .

SCCC

1. Memos

CALGB

1. CLOSURES/SUSPENSIONS/REACTIVATIONS*

CALGB 10503 Closure

CALGB 40101 Closure

CALGB 40302 Closure

CALGB 360401 Closure

2. UPDATES*

CALGB 10503 Corrected Update 6 Memo

CALGB C80405 Revised Action Letter Re Update 8

CALGB Adverse Event Reports:

AZD2171 (80502) AE 1130115FU 6/24/10 (7/15/10)

Bevacizumab (30306, 40502, 40503, 40504, 40603, 80303, 80405, 90206, 90401,

90601) AE 1190366 5/28/10, 1901777 FU 6/2/10, 1996104 FU 5/24/10 (7/15/10)

Bevacizumab/Temsirolimus (30306, 40502, 40503, 40504, 40603, 80303, 80405,

90206, 90401, 90601) AE 1981052 6/17/10, 1249518 FU 6/24/10, 1448075 FU 5/26/10 (7/15/10)

Bortezomib (30402, 10502, 50403, 50501) AE 1850085 FU 5/25/10, 1887123 FU

6/14/10 (7/15/10)

Dasatinib (30601, 30602) AE 1640686 FU 6/18/10, 1983486 6/28/10 (7/15/10)

Decitabine (10503) AE 1684056 6/2/10 (7/15/10)

Erlotinib/IMC-A12 ( 30605, 30406) AE 1203166 6/2/10, 1398066 6/4/10, 1559936

6/12/10 (7/15/10)

Sunitinib (30504, 30607, 30704, 80603) AE 1788898 6/3/10, 1842265 6/25/10 (7/15/10)

3. NEW PROTOCOLS*

4. CONSENT FORM CHANGES*

*Needs IRB Approval

CCCWFU

1. CLOSURES/SUSPENSIONS/REACTIVATIONS*

2 UPDATES

3. NEW PROTOCOLS*

4. CONSENT FORM CHANGES

*Needs IRB Approval

CTSU

1. CLOSURES/SUSPENSIONS/REACTIVATIONS*

CTSU/ECOG PACCT-1 Pre-Registration Closure

2. MEMOS

CTSU/NCCTG N0577 Error in Dose Modification table

3. UPDATES*

CTSU/ACOSOG Z1041 Version A5 + Consent Form

CTSU/ECOG E1A06 Addendum 6 + Consent Form

CTSU/ECOG E1505 Addendum 8 + Consent Form

CTSU/ECOG E2204 Addendum 5 + Consent Form + Action Letter

CTSU/ECOG E2603 Addendum 12 + Consent Form

CTSU/ECOG E2805 Addendum 10 + Consent Form

CTSU/ECOG E3F05 Update 4

CTSU/ECOG E5103 Addendum 6 + Consent Form

CTSU/ECOG E5202 Addendum 11 + Consent Form

CTSU/GOG-0263 Update 7/19/10

CTSU/IBCSG 24-02 Amendment 1

CTSU SAE Reports:

Bevacizumab/CCI-779 ( E1105, E1305, E1505, E2104, E2204, E2404, E2804, E3204,

E3501, E4203, E5103, E5202, E5204) AE 190177FU 1-1 7/7/10; AE 1249515

FU1 AND 1981052-ISR 7/7/10 (7/8/10)

CCI-779 (E2804) AE 1497480-ISR 7/7/10 (7/8/10)

Cetuximab ( E2303, E3205, E2204, E1308, E1504) Correction to Cetuximab Action

Letter for E2204

Cetuximab (N0147) Action Letter 7/19/10

Exemestane/Triptorelin (24-02, 25-02) AE 10000726 6/29/10, 10000722 6/30/10

(7/8/10)

IMC-A12 (N0733) AE_1097524 7/15/10, AE_1791876_FU1 7/20/10, AE_10-13-00301

(DDL 081) 7/9/10

PS-341 (E1303, E1304, E1405, E6202, E1A05, E2A02) AE 1887123 FU 1-2 6/23/10

(7/8/10)

Sunitinib Malate (E2805) AE 1842265 7/7/10, 1788898 6/23/10 (7/8/10)

Tamoxifen (24-02, 25-02) AE 10000727 6/29/10, 10000724 6/30/10 (7/8/10)

Tamoxifen/Triptorelin (24-02, 25-02) AE 10000717 6/22/10 (7/8/10)

Tamoxifen/Triptorelin/Zoladex (24-02, 25-02) AE 10000723 6/30/10, 10000723 6/30/10

(7/8/10)

Thalidomide (E1A00, E3598, E4A03) AE 1050732-ISR-1 6/23/10 (7/8/10)

4. NEW PROTOCOLS*

CTSU/GOG-0263

CTSU/NCIC MA.32

CTSU/NCCTG N08CB

CTSU/NCIC Pr.11

5. CONSENT FORM CHANGES

*Needs IRB Approval

NSABP

1. CLOSURES/SUSPENSIONS/REACTIVATIONS*

NSABP R-04 Closure Second Notice

2. MEMOS

NSABP B-35 Updated Arimidex IB

3. UPDATES*

NSABP Safety Reports:

Bevacizumab (B-40, FB-5) AE 711744 7/6/10, 1070874-F1 7/7/10, 713959 7/13/10,

1190366-F1 7/13/10 (7/21/10)

Bevacizumab (B-46-I) AE 711744 7/6/10, 713959 7/13/10 (7/21/10)

Bonefos (B-34) Safety Update 242 7/15/10, #243 7/15/10, #244 7/15/10, #245 7/20/10,

#223 FU1 7/20/10, #109 FU 2 7/20/10 (7/21/10)

Gemcitabine (B-38, B-40) DE201006006707 6/30/10, DE201006005927 7/1/10,

GB201006005586 7/2/10, AU201006007357, IT201005004319F1, US201006001303F1, DE201007000567, US201003008488F1, FR201004000529F1 7/6/10, GB201007001033, DE201006006985, 7/7/10, HU201006007222F1, US201006007343 7/8/10, DE201006001310F2, HU201006007197F1, RU201006006785, US201006007617, US201007001525 7/9/10, DE201007000677 7/13/10, GB201006003464F1 , US201007000564 7/14/10, DE201007002152 7/16/10, GB201007002815 7/16/10 (7/21/10)

Pazopanib (FB-6) AE Z0002351A FU3, Z0002573A FU2 6/29/10, B0652467A FU2,

Z0002913A FU3 6/30/10, B0633731A FU 7/6/10, Z0002095C FU, B0571478C FU, B0406784A FU3 7/7/10, B0663615A 7/13/10, Z0002095C FU2, B0424074A FU5 7/19/10

4. NEW PROTOCOLS*

*Needs IRB Approval

RTOG

1. CLOSURES/SUSPENSIONS/REACTIVATIONS*

RTOG 0614 Closure

2. MEMOS

Important information for RTOG 0436, 0617 and 0920 Revised Action Letter

3. UPDATES*

0627 Amendment 8 + Update

4. NEW PROTOCOLS*

RTOG 0841** Update 7/15/10, Update 7/1/10, Amendment 1,

2 + Consent Form (has been on Hold)

RTOG 0929 Protocol, Consent, HIPAA, RSS form and DARFS

*Needs IRB Approval

SWOG

1. CLOSURES/SUSPENSIONS/REACTIVATIONS*

SWOG/NCCTG N0724 Closure

2. MEMOS

3. UPDATES*

SWOG Safety Memorandums:

AVE0005 (S0802) Mfr Rpt 200920926GDDC, 200915572GDDC, 2010SA000369

6/22/10 (7/15/10)

AZD2171 (S0509, S0905) AE 1130115 6/24/10, 1856685 6/30/10 (7/15/10)

Bevacizumab (S0518, S0533, S0536, S0600, S0635, S0636, S0800) AE 1249518

6/23/10 (7/15/10)

Bonefos (S0307) AE 201012401NA 6/9/10, 201023699NA, 201024770NA,

201027595GPV, 201028474GPV 6/16/10 (7/15/10)

CCI-779 (S0438) AE 1249518 6/23/10 (7/15/10)

Dasatinib (S0325, S0622, S0711, S0805) AE 1983486 6/28/10 (7/15/10)

IMC-A12 (S0727) Mfr Rpt 101300301 6/24/10 (7/15/10)

SCH727965 (S0826) AE 1937731 6/28/10, 1161358 7/1/10 (7/15/10)

4. NEW PROTOCOLS*

*Needs IRB Approval