NCT00003120 - Clinical Trial References

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Citation(s)

Liu P, Moon J, Alberts DS, et al
: A modified CA-125 progression criterion in ovarian cancer (OC) patients (pts) receiving maintenance treatment following complete clinical response (cCR) to primary therapy. [Abstract] J Clin Oncol 24 (Suppl 18): A-5080,
Liu PY, Alberts DS, Monk BJ, et al
: Relationship between pretreatment CA-125 level and risk of relapse in advanced ovarian cancer (AOC) patients in a complete clinical response (CCR) who received "maintenance therapy". [Abstract] J Clin Oncol 23 (Suppl 16): A-5013, 458s, 2005.
Markman M, Liu P, Wilczynski S, et al
: Survival (S) of ovarian cancer (OC) patients (pts) treated on SWOG9701/GOG178: 12 versus (v) 3 cycles (C) of monthly single-agent paclitaxel (PAC) following attainment of a clinically-defined complete response (CR)
Markman M, Liu PY, Rothenberg ML, Monk BJ, Brady M, Alberts DS
Pretreatment CA-125 and risk of relapse in advanced ovarian cancer. J Clin Oncol. 2006 Mar 20;24(9):1454-8.
Markman M, Liu PY, Wilczynski S, Monk B, Copeland LJ, Alvarez RD, Jiang C, Alberts D; Southwest Oncology Group; Gynecologic Oncology Group
Phase III randomized trial of 12 versus 3 months of maintenance paclitaxel in patients with advanced ovarian cancer
Markman M
Maintenance chemotherapy in advanced ovarian cancer: the US experience. Int J Gynecol Cancer. 2008 Mar-Apr;18 Suppl 1:40-3. doi: 10.1111/j.1525-1438.2007.01104.x. Review.

Phase III Randomized Trial of 12 Months vs. 3 Months of Paclitaxel in Patients With Advanced Ovarian Cancer Who Attain a Clinically Defined Complete Response (CR) Following Platinum/Paclitaxel-Based Chemotherapy

Details for clinical trial NCT00003120

Clinical trial NCT00003120 - References