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Old 05-29-2011, 08:48 AM   #1
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Location: Central Coast, CA
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Exclamation TDM1 EAP -Good news for those in TDM1 EAP who need to travel

Just received this information from the Patient Advocate at Genentech. They are working to amend the protocol for the EAP (T-PAS) to allow SOME of the actual treatments to be adminstered locally. They are still not opening any new study sites...but those who, say live in Boston and would have to travel to Fairfax (or in Seattle traveling to So Cal or in Austin going to Denver) may have an option, once they are established in the trial, to get some infusions locally. This is still probably a few months away to get the amendment done and approved.

Still not as good a FDA approval of the drug...but may provide some relief in the interim...

The message she sent me is below:

Genentech has been contacted by multiple patients requesting T-DM1 from their local oncologist as part of T-PAS or seeking individual access. We know that many people have to travel long distances, and we recognize this significant burden, especially considering their advanced cancer. We are trying to do the right thing for patients while ensuring we are being fair, and also not impacting the clinical trials we need to conduct in order to get the medicine approved. Therefore, we are planning to amend the T-PAS protocol, allowing people who are enrolled in the trial and responding to T-DM1 to receive some T-DM1 doses locally. Additional details of the protocol amendment are not yet final, but we are working as quickly as possible and hope to have the amendment in place within 90 days. Our primary goal remains getting T-DM1 approved so access is not an issue for patients.
While we understand it can be difficult and costly to travel long distances, our hope is the amendment alleviates some of the burden by allowing some doses to be administered by a local oncologist. While we are working to get the amendment approved, we recommend people who continue to face travel challenges to contact an organization that may be able to provide travel assistance:

· Air Care Alliance, www.aircareall.org, 888-260-9707
· Air Charity Network, www.aircharitynetwork.org, 877-621-7177
· Airlines of the Web Medical Air Services, www.flyaow.com/airmed.htm
· American Cancer Society (Road to Recovery), www.cancer.org, 800-ACS-2345
· Angel Flight Central, www.angelflightcentral.org, 866-569-9464
· Angel Flight for Cancer Patients, www.angelflightforcancerpatients.org, 800-296-1217
· AVONCares Program, www.cancercare.org, 800-813-HOPE
· CancerCare, www.cancercare.org, 800-813-HOPE
· Chai Lifeline, www.chailifeline.org
· Corporate Angel Network, www.corpangelnetwork.org, 866-328-1313
· Hospitality Homes, www.hosp.org, 888-595-4678
· Joe’s House, www.joeshouse.org, 877-JOESHOU
· Lazarex Cancer Foundation, www.lazarex.org/lookingforhelp.html
· Lifeline Pilots, www.lifelinepilots.org, 800-822-7972
· National Patient Travel Helpline, www.PatientTravel.org, 800-296-1217
Chris in Scotts Valley
June 2002 extensive hi grade DCIS (pre-cancer-stage 0, clean sentinal node) Mastectomy/implant - no chemo, rads. "cured?"
9/2004 Diag: Stage IV extensive liver mets (!) ER/PR- Her2+++
10/04-3/05 Weekly Taxol/Carboplatin/Herceptin , complete response!
04/05 - 4/07 Herception every 3 wks, Continue NED
04/07 - recurrence to liver - 2 spots, starting tykerb/avastin trial
06/07 8/07 10/07 Scans show stable, continue on Tykerb/Avastin
01/08 Progression in liver
02/08 Begin (TDM1) trial
08/08 NED! It's Working! Continue on TDM1
02/09 Continue NED
02/10 Continue NED. 5/10 9/10 Scans NED 10/10 Scans NED
12/10 Scans not clear....4/11 Scans suggest progression 6/11 progression confirmed in liver
07/11 - 11/11 Herceptin/Xeloda -not working:(
12/11 Begin MM302 Phase I trial - bust:(
03/12 3rd times the charm? AKT trial

5/12 Scan shows reduction! 7/12 More reduction!!!!
8/12 Whoops...progression...trying for Perjeta/Herceptin (plus some more nasty chemo!)
9/12 Start Perjeta/Herceptin, chemo on hold due to infection/wound in leg, added on cycle 2 &3
11/12 Poops! progression in liver, Stop Perjeta/Taxo/Herc
11/12 Navelbine/Herce[ptin - try for a 3 cycles, no go.
2/13 Gemzar/Carbo/Herceptin - no go.
3/13 TACE procedure
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Old 05-29-2011, 03:02 PM   #2
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Re: TDM1 EAP -Good news for those in TDM1 EAP who need to travel

At least that's a start and I'm sure that will help some of the ladies that are traveling so far. I know Genentech has received alot of calls about how difficult, or should I say near impossible for many of us ladies to get to these EAP sites. I've personally made serveral calls myself over this one issue. The financial aspect of it's a deal breaker for so many.

I still hate to hear it will be another 3 months or so. That's a long time in a stage IV's world with all the appts we have...along with the fatigue and all that comes with it. But it is nice to see they are working on it. I am sure Genentech has been inundated with calls about T-DM1 and all the issues surrounding it. I just wish the FDA would give it's final approval and be done with this. Thanks for sharing this news with us Chris....surely appreciate it.

DX: 12-20-05 - Stage IIIA, Her2/Neu, 3+++,Er & Pr weakly positive, 5 of 16 pos nodes.
Rt. MRM on 1-3-06 -- No Rads due to compromised lungs.
Chemo started 2-7-06 -- TCH - - Finished 6-12-06
Finished yr of wkly herceptin 3-19-07
3-15-07 Lt side prophylactic simple mastectomy. -- Ooph 4-05-07
9-21-09 PET/CT "Recurrence" to Rt. axllia, Rt. femur, ilium. Possible Sacrum & liver? Now stage IV.
9-28-09 Loading dose of Herceptin & started Zometa
9-29-09 Power Port Placement
10-24-09 Mass 6.4 x 4.7 cm on Rt. femur head.
11-19-09 RT. Femur surgery - Rod placed
12-7-09 Navelbine added to Herceptin/Zometa.
3-23-10 Ten days of rads to RT femur. Completed.
4-05-10 Quit Navelbine--Herceptin/Zometa alone.
5-4-10 Appt. with Dr. Slamon to see what is next? Waiting on FISH results from femur biopsy.
Results to FISH was unsuccessful--this happens less then 2% of the time.
7-7-10 Recurrence to RT axilla again. Back to UCLA for options.
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Old 06-01-2011, 03:04 PM   #3
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Location: New York, New York
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Re: TDM1 EAP -Good news for those in TDM1 EAP who need to travel

If anyone has been following Lorraine and Phil McCartin's journey, it's apparent the toll traveling takes, especially via plane and having an overnight stay. I saw on their Facebook page yesterday that Genentech will now allow Lorraine to receive her treatment at home in Boston, beginning in a few weeks. For those who don't know, Phil McCartin has been a huge (political and local) advocate in getting T-DM1 to people who need it most.
Hurray, Lorraine!
World Trade Center Survivor (56th Floor/North Tower): 14 years and still just like yesterday.
Graves Disease, became Euthyroid via Radioactive Iodine, June 2001.
Thyroid Eye Disease. 2003. Decompression surgery in 2009; eyelid lowering surgery in 2010.
Diagnosed: June 2010, liver mets. ER-/PR+10%; HER2+++.
July 2010: Begin Taxol/Herceptin. Eliminate sugar from diet. No surgery or radiation.
January 2011: NED
April 2011: Progression in liver only. Other previous affected areas eradicated. Stop Taxol/Herceptin after 32 infusions.
May 2011: Brain MRI: clear.
May 2011: Begin Tykerb daily, Xeloda twice per day for one week on, one week off, and Herceptin.
November 2011: Progression in liver. All other tumors remain eradicated.
December 2011: BEGIN TRIAL #09-093 Taxol, MCC-DM1 (T-DM1), Perjeta.
Trial requires scans every six weeks, bloodwork and infusions weekly.
Brain MRI: clear.
January 2012: NED. Liver mets, good riddance!
March 2012: NED. Developed SMA (rare blood clot) in intestinal artery and loss of sight in right eye due to optical nerve neuropathy. Resolved when Taxol removed this month.
Continue Protocol of T-DM1 weekly and Perjeta every 3 weeks.
May 2012: NED.
June 2012: Brain MRI: clear.
June-December 2012: NED.
December 2012: TRIAL CONCLUDED; ENTER TRIAL EXTENSION #09-037. CT, Brain MRI, bone scan: clear. NED.
January-March 2013: NED.
June 2013: Brain MRI: clear. CEA upticking; CT shows new met on liver.
July 3, 2013: DISASTER STRIKES during liver ablation: sloppy surgeon cuts intercostal artery and I bleed out, lose 3.5 liters of blood, have major hemothorax, and collapsed lung requiring emergency resuscitative thoracotomy, lung surgery, rib rearrangement and cutting deep connective tissue, transfusion. Ablation incomplete. This life-saving procedure would end up causing me unforgiving pain with every movement I make, permanently, otherwise known as forever.
July 26, 2013: Try Navelbine/Herceptin. Body too weak after surgery and transfusion. Fever. CEA: Normal.
August 16, 2016: second dose Navelbine/Herceptin; CEA: Normal. Will skip doses. Watching and waiting.
September 2013: NED, Herceptin only. CEA: Normal. Started Arimidex.
October-November 2013: NED. Herceptin and Arimidex. CEA, CA125, 15-3: Normal.
December 2013: Something brewing. PET lights up on little spot on liver; CEA upward trend, just outside normal. PET and triphasic liver scan confirm Little Met. Restart Perjeta with Herceptin, stay on Arimidex. Genomic sequencing completed for future treatments, if necessary.
January 2014: Ablate Little Met on the 6th. Happy New Year.
March 2014: Brain MRI: clear. PET/CT reveal liver mets return; new lung mets. This is not funny.
March 2014: BEGIN TRIAL #10-005 A(11)-Temsirolimus plus Neratinib.
April 2014: Genomic testing indicated they could work, they did not. Very strange drug combo for me, felt weird.
April 2014: Started Navelbine and Herceptin. Needed something tried and true, but had significant progression.
June 2014: Doxil and Herceptin.
July 2014: Progression. Got nothing out of it. Brain: NED.
July 2014: Add integrative medical hematologist-oncologist to my team. Begin supplements. These are tumor-busting, immune system boosters. Add glutathione, lysine and taurine IV infusions every three weeks.
July 2014: Begin Gemzar, Herceptin & Perjeta. Happy.
August 2014: ECHO perfect.
January 2015: Begin weekly Vitamin D Analog infusions. 25 mcg. via port.
February 2015: CT: stable.
April 2015: Gem working, but not 100%. Looking into immunotherapy. Finally, treatments for the 21st century!
April 2015: Penn Medicine. Dendritic cell immunotherapy.
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Old 06-19-2011, 02:10 PM   #4
Join Date: Mar 2011
Location: Atlanta, Ga USA
Posts: 6
Re: TDM1 EAP -Good news for those in TDM1 EAP who need to travel

Great news, Chrisy! Thanks for sharing. I am participating in a T-DM1 trial in Charleston, SC, traveling from Atlanta. The trial is going well for me. I just found out on Friday, after 9 weeks on the trial, that the T-DM1 is working! My tumors have either shrunken or remained stable. I had not anticipated when I signed on for the trial how difficult the traveling would be. It is the worst part of the experience for me, so your news is very welcome. Thanks! Ann
5/05-2 lumpectomies, cancer in 3 sentinel nodes,
9 nodes removed. HER2+++, ER/PR-.
7/05-bilateral mastectomy, reconstruction from thighs.
Port placement in chest.
7/05 to 12/06-Chemo: A/C, Taxol, Herceptin. NED. Port removed.
12/05-silicone implant.
5/08-METS to liver, bones, nodes in chest wall & around kidneys. Power Port placed in chest. Chemo: Xeloda, plus Zomeda, Herceptin.
2/11-CT showed new tumors inside pelvic wall. Largest 2 cm.
4/11-CT shows largest tumor had grown to 3 cm. Started T-DM1 trial.
6/11-CT shows largest Tumor shrank. Others stable.
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Old 06-21-2011, 07:38 PM   #5
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Re: TDM1 EAP -Good news for those in TDM1 EAP who need to travel

Genentech has asked the FDA to approve an " amendment to the Access protocol ". Allowing pts who are enrolled, and responding to the drug, to petition to switch the tx to a hospital/clinic closer to home. So, we could get it in Boston. And others closer to their homes. Time frame : before the end of Aug. Maybe sooner.
Whats really important, if you want the drug, you could travel to the nearest access site, enroll, get 3-4 doses, get cts, and if its working, switch to a closer hosp./clinic. That would mean traveling for about 3 months. Once every 3 weeks.
We remain big on this drug. W/ heavily pre-treated pts like L. , the drug does knock down platelets. But it also knocks the crap out of her2 cancer. L. had to go 7 weeks w/o it, due to sepsis ( un-related to t dm-1 , a stent from last yrs " collateral dmage, taxanes, adria etc. ). Even w/ a reduced dose , after 7 weeks W?O ANY DRUG, her counts are great ( except plats ). Good energy, full head of hair, no chemo brain ( that ones L. reading over my shoulder). We hope to get as much of the drug as plats allow until approval. You know I am on the FDA's case , every week. Now that Gen. is being more flexible, our full attention should be on this FDA Administration. Dont forget, we wouldnt be having this struggle if they had approved it last yr.
L. and I hope to be in DC next week, to support the Avastin survivors. All of you w/in 2-3 hrs travel time of the FDA should be there too.Watch, and learn as the FDA tries to stone-wall them. I've told them , tell your stories . They are powerful, to the press , thus to the people. No matter what the FDA decides about Avastin next Tues,. IT AINT OVER ! Until their way of doing " business " is changed.
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Old 08-06-2011, 08:22 AM   #6
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Re: TDM1 EAP -Good news for those in TDM1 EAP who need to travel

Great information on this thread... Just bumping it to make it more accessible...!
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Old 08-06-2011, 05:51 PM   #7
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Re: TDM1 EAP -Good news for those in TDM1 EAP who need to travel

Went to DC last wk. Got dose # 9. Latest Ct, counts look great. Still hearing that we will be able to transfer tx. to Boston in about a month. Access will close Sept. 6th. Have heard of at least more women from NYC who have enrolled out of state, Va. Mich. Because the access is closing.
After Sept. 6th, there will only be trials, w/ extra requirements, 30 day wash-out vs. only 2 weeks for access. Closing of access is due to this FDA 's obstinate refusal to see whats right in front of their eyes. No respect for Stage IV Survivors, no compassion. They have decided to make you guinea pigs for thier new , more rigid regs. " Overall Survival " stas. harder to prove, and definitely morally wrong w/ this drug. Until this FDA's ruling on T DM-1 is investigated, overturned. Only way is to bring it to the Publics attention, again, and again. All of you on taxanes, tyk/xel., this FDA is extending your suffering . Denying you a low s/e , even better drug. Call your Congr. Reps. have they called the FDa ? Their own HELP Committee ? Asked Dr. Sebelius in HHS to investigate ?
If you are metastatic Her2 , this drug has to be checked out. If you are suffering w/ s/e of tyk./xel. , and have already progressed on taxanes. You may qualify based on intolerance of tyk./xel. You need an assertive doc, to help you argue your case. All docs tend to be conservative, its in their training. Even the nice ones, you need to give them a push. And they are all busy, what? 18 pts a day ?
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Old 08-28-2011, 09:32 AM   #8
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Re: TDM1 EAP -Good news for those in TDM1 EAP who need to travel

Want to make sure that all of you traveling to get t dm-1 know that the FDA has now allowed transfer to a site closer to your home. Our clinic in Va. has already begun the paperwork process. Transferring to the Farber in Boston, YAY !!! Push your site to get the process started. They are very busy, so always speak up ! Heres to no more expensive, stressful trips ! ( nevermind needless, Thanks FDA ! ).
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