Notes Submitted to the IOM Pertaining to Moffitt Trial NCT00720096

Background of Moffitt Trial NCT00720096, re the IOM Omics Review

In September 2009, we identified four trials on (NCT00509366, NCT00545948, NCT00636441, NCT00720096) whose descriptions suggested they were using signatures introduced by Potti et al (Nat Med, 2006) to guide patient therapy (the Cancer Letter, Oct 2, 2009). The subsequent history of three of these trials (run at Duke) has been widely covered. The fourth (NCT00720096), "Genomic Directed Salvage Chemotherapy with either Liposomal Doxorubicin or Topotecan", dealt with predicting response in recurrent ovarian cancer, and was run at the Moffitt Cancer Center; this trial was terminated Oct 8, 2009.

In 2011, the IOM Omics Review Committee sought further details about this trial; the Moffitt provided versions of the trial protocol and informed consent forms in August, and addressed specific questions posed in a letter in late September. The NCI responded to the Moffitt letter with a letter of their own in late October, pointing out various points of disagreement. This was covered in the Nov 4, 2011 issue of the Cancer Letter. All of these documents, which are publicly available from the IOM, are also posted below.

We recommend reading the two letters, and augmenting with the protocols and/or consents as desired.

Relevant Files

1. Letter from William Dalton, Moffitt Cancer Center CEO, re the mechanics of NCT00720096, dated Sep 28, 2011.
2. Letter from Lisa McShane, NCI, commenting on issues raised in Dalton's letter, dated Oct 23, 2011.
3. NCT00720096 Trial Protocol (zip file), version 10, 10/19/07, version 13, 1/10/08, version 14, 7/14/08, version 15, 1/26/09, version 15, 6/9/09.
4. NCT00720096 Trial Informed Consents (zip file), version 1, 10/22/07, version 2, 11/16/07, version 3, 1/10/08, version 4, 1/26/09, version 5, 7/20/09, version 6, 8/24/09.
5. List of PAFs Available from the IOM, as of 10/23/11, pertaining to the IOM Omics committee.