Patients

For Patients - GOG-3003

GOG-3003 Trial in Ovarian Cancer

Important Information

Everyone in the study will begin treatment with the same standard-of-care chemotherapy treatment (pegylated liposomal doxorubicin), an FDA-approved chemotherapy for patients with persistent or recurrent ovarian cancer. The only treatment difference in this study is that some women will receive chemotherapy AND motolimod and others will receive chemotherapy AND a placebo (an injection that does not contain active drug).

Study Overview

The GOG-3003 study is being carried out by the Gynecologic Oncology Group (GOG), an organization dedicated to clinical research in the field of gynecologic cancer. The purpose of this study is to compare the FDA-approved chemotherapy, pegylated liposomal doxorubicin (PLD; a standard chemotherapy) to PLD in combination with motolimod (a new type of investigational drug that stimulates the immune system) to see if the combination helps cancerous tumors stop growing or shrink, and if it helps women with recurrent or resistant ovarian cancer live longer. Researchers also want to evaluate the side effects of the combination of PLD and motolimod.

The study is being conducted at more than 75 centers throughout the United States. Over 200 women will participate in the trial. For more information about the location of an open center near you, please go to www.clinicaltrials.gov.

GOG-3003 is a randomized, double-blind, placebo-controlled trial. This means that although every woman on the study will receive the standard therapy of PLD, neither a patient nor her doctor will know if she is receiving motolimod or a placebo along with chemotherapy (PLD).

Study Rationale

PLD is an FDA-approved treatment for women with ovarian cancer. In prior studies, approximately 15–20% of women who received PLD for relapsed ovarian cancer experienced a temporary shrinkage or disappearance of their tumor. Doctors hope that treatment with the combination of PLD plus motolimod will be more effective against cancer compared to treatment with PLD alone.

The combination of PLD + motolimod has been evaluated in a previous study of 13 patients. Results show that the two drugs can be given together without too many new serious side effects. In addition, research blood tests show that motolimod stimulated the immune system in all the patients. Study results show there is some evidence that PLD + motolimod may temporarily stop some patients' tumors from growing or it may help cancer tumors temporarily shrink and/or disappear.

About Ovarian Cancer

Ovarian cancer is a disease in which malignant, or cancerous, cells are found in the tissues of the ovary. Normally, cells divide and grow to form new cells when the body needs them. Eventually these cells will die and are replaced by new ones. Sometimes, the process becomes disrupted and new cells may grow uncontrollably, creating a tumor, which can be benign (or non-cancerous) or malignant (cancerous).

While benign tumors generally do not spread to adjacent tissues, malignant tumors do invade adjacent tissue. Cells from malignant tumors also can move to distant parts of the body, breaking away from the primary tumor. This is called metastasis. These metastatic cells invade other organs and damage them, which can be life-threatening.

Cancerous ovarian cells from the primary tumor can spread to the nearby fallopian tubes and the other ovary. Ovarian cancer cells also can shed into the abdominal cavity and cause new tumors on the surface of nearby organ or tissues, such as the peritoneum, a tissue that lines the abdominal and pelvic cavities.

Recurrent Disease

Although most ovarian cancers respond well to initial chemotherapies, many women diagnosed with an advanced stage disease will experience a recurrence of cancer.

An important concept to understand in ovarian cancer is 'time to recurrence.' This refers to the time between a woman's initial response to platinum-based chemotherapy and a diagnosis of recurrent ovarian cancer. Based on the length of time to recurrence, ovarian cancer is generally classified as either platinum-sensitive or platinum-resistant. This classification influences a woman's prognosis as well as the type of treatment selected for recurrent ovarian cancer. If ovarian cancer does not respond to primary treatment with a platinum agent (such as cisplatin or carboplatin), or if the cancer returns within 12 months of completing platinum-based chemotherapy, the cancer is considered platinum-resistant disease.

A woman's doctor will determine the most appropriate treatment based on the type of recurrent ovarian cancer a woman has experienced.