Many patients are interested in clinical trial participation. In this section, we will be featuring selective clinical trials that might be of special interest to those with gynecologic cancers.These are not meant to be all inclusive, and additional information about clinical trial availability is provided at the end of this section. Due to the nature of clinical trials, it is impossible to guarantee a benefit from participating, and not all patients will be eligible. Please discuss eligibility criteria with your doctor, who will also help you to decide whether a given clinical trial is appropriate for you.

Protocol title: Oral Topotecan as consolidation therapy for patients with advanced ovarian, fallopian tube, and primary peritoneal serous cancers in first remission.

Protocol chairperson: Stephen A. Cannistra, M.D., Director of Gynecologic Medical Oncology, Associate Professor of Medicine, Harvard Medical School, Beth Israel Deaconess Cancer Center, Boston, MA.

Rationale for this study: Patients with advanced ovarian cancer, fallopian tube cancer, or primary peritoneal serous cancer typically receive initial treatment with chemotherapy agents such as paclitaxel (Taxol™) and carboplatin. After several months of treatment, the disease will often go into "remission," meaning that the physical exam, the CA-125 level, and the CT scan become normal. Although the paclitaxel and carboplatin regimen currently offers the best chance of achieving a remission, these cancers do not always stay in remission. This is because small amounts of tumor may still be present after paclitaxel and carboplatin treatment (too small to be detected by exam, CA-125 level, and CT scans). This small amount of tumor grows back to cause relapse in many patients. Although many chemotherapy drugs can be used to control tumors once they relapse, resistance to these agents eventually limits their usefulness. Both patients and physicians agree that the best way to fight this disease is to decrease the chance that it will ever recur, once remission is achieved.

Many approaches have been tried in an effort to prolong remission and/or prevent relapse in patients with tumors like ovarian cancer. Approaches such as intraperitoneal chemotherapy, radiation, antibody-directed treatment, or prolonged use of chemotherapy with agents like platinum or melphalan have not yet shown convincing benefit. Recently, a randomized trial from the Gynecologic Oncology Group showed that continuing paclitaxel (Taxol™) after achieving remission delayed the onset of recurrence by an average of about 7 months. Unfortunately, this did not seem to prolong the lifespan of patients with ovarian cancer, and it required a full year of paclitaxel treatment with associated side effects such as neuropathy. Hence, the standard of care for patients with diseases like ovarian cancer still remains simple observation after achievement of a remission with paclitaxel and carboplatin.

The current trial recognizes the need for better therapies capable of prolonging remission and/or preventing relapse in patients with ovarian, fallopian tube, and primary peritoneal cancers. Instead of using drugs like paclitaxel or carboplatin, which patients have already received during first-line therapy, this trial uses an oral (pill) form of a newer agent called topotecan. Because topotecan works in a different way compared to paclitaxel and carboplatin, we know that it is capable of killing cancer cells that have become resistant to these first-line agents. Because it is an oral agent, it should be more convenient for patients to receive. However, as with all clinical trials, it is unknown whether there will be any benefits associated with this study.

How the drug is administered: The safe dose range of oral topotecan is well-known from prior studies, and we will use this dose range in the current trial as well. The drug will be administered orally (in pill form) and will be taken twice daily as tolerated, for 3 weeks out of every 4 weeks. This 4 week period is referred to as a "cycle." Blood counts will be checked weekly, and patients will be asked to keep a simple diary to assess for other side effects such as diarrhea. Dose adjustments may be necessary during the course of the trial in an individual patient based upon tolerance. The total treatment length will be 6 months (6 cycles) as tolerated.

Phase of study: Although the safe dose range of oral topotecan is already known, we have chosen to call this a phase I study since we intend to administer this drug for up to 6 months in order to give it the greatest chance of killing residual cancer cells that remain after first-line therapy.

Eligibility: Only some of the eligibility criteria are mentioned here, and evaluation by a physician will ultimately be necessary to determine eligibility. Patients must have a diagnosis of advanced ovarian, fallopian tube, or primary peritoneal serous cancer. They must be healthy and have normal laboratory tests. They must be in a first remission (normal exam, normal CA-125, and normal CT scan). A second-look laparoscopy is NOT required for study entry, since this procedure has not been proven to directly benefit patients (and the information from second-look procedures is not always reliable). Patients must provide informed consent. Other eligibility requirements and a full review of possible side effects will be discussed by your physician.

How to learn more about this trial: Potentially interested patients should contact Dr. Stephen A. Cannistra at 617-667-4283 for more information.

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