A Randomized Phase III Trial of Maintenance Chemotherapy Comparing 12 Monthly Cycles of Single Agent Paclitaxel or CT 2103 (IND# 70177) Versus No Treatment Until Documented Relapse in Women With Advanced Ovarian, Primary Peritoneal, or Fallopian Tube Cancer who Achieve a Complete Clinical Response to Primary Platinum/Taxane Chemotherapy Save

Date Added
November 16th, 2012
PRO Number
Pro00020221
Researcher
William Creasman

Silhouette
Keywords
Cancer, Women's Health
Summary

This study is for patients with ovarian, primary peritoneal or fallopian tube cancer that has been confirmed by surgery. Primary peritoneal and fallopian tube cancers are considered identical to ovarian cancers in terms of microscopic appearance and treatment; they differ only by the initial body site of cancer development. In this research study, women with advanced ovarian, primary peritoneal or fallopian tube cancer who have no evidence of disease after the completion of initial chemotherapy will be randomly assigned (like the flipping of a coin) to one of the three possible treatment regimens to determine which will result in longer patient survival rates if continued once a month for 12 months versus stopping all chemotherapy until there is evidence of recurrence of the disease process. Patients have an equal chance of being placed in any one of the three regimens. Neither the patient nor the study doctor will decide which regimen will be received. Two different chemotherapy regimens and one regimen including no further treatment will be examined and compared. The first of the chemotherapy arms, paclitaxel, is a standard chemotherapy drug used to treat ovarian cancer. The second agent, CT-2103, is an experimental drug with anti-cancer activity similar to that of paclitaxel.

Patients will undergo a thorough check-up prior to the start of treatment. Additionally, they will be asked to complete a questionnaire about their quality of life a total of six times: once before going on the study, 2, 4, 6 and 12 months later, and then one year after completing treatment.

If patients are randomized to receive either paclitaxel or CT-2103, they will be given the drug, once a month through their vein, for a maximum of 12 monthly cycles. The paclitaxel is delivered over 3 hours, while CT-2103 is given as a 10-20 minute infusion.

This study is also interested in testing samples of patients' blood and tumors to determine if this testing can be used in the future to determine which patients may respond to treatment, have side effects or have a good prognosis.

Patients randomized to receive either paclitaxel or CT-2103 will recieve treatment for a maximum of 12 months depending on how well they respond and the seriousness of any side effects. The study doctor will follow patients' medical condition by office visits every three months for two years and then every six months for three more years.

Institution
MUSC
Recruitment Contact
Anne Wulf
843-792-9190
olsenk@musc.edu

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