Active clinical trials for "Ovarian Neoplasms"

The main purpose of this study is to investigate the effect of veliparib in ovarian cancer patients with known BRCA 1/2 mutations who do no longer respond to conventional chemotherapy.

This is a study of CDX-1127, a therapy that targets the immune system and may act to promote anti-cancer effects. The study enrolls patients with hematologic cancers (certain leukemias and lymphomas), as well as patients with select types of solid tumors.

Neoadjuvant chemotherapy is alternative treatment option to upfront cytoreductive surgery to treat advanced ovarian cancer. Paclitaxel plus carboplatin is most frequently selected chemotherapeutic regimen for neoadjuvant chemotherapy. Docetaxel had similar therapeutic efficacy compared to paclitaxel in adjuvant chemotherapy trials in ovarian cancer. However, docetaxel had more favorable toxicity profile. Therefore, the investigators aimed to evaluate the efficacy of docetaxel plus carboplatin as neoadjuvant chemotherapy in patients with advanced ovarian cancer.

The purpose of this study is: Phase A: To confirm the feasibility of paclitaxel administered by intravenous (IV) infusion weekly plus concurrent carboplatin administered by intraperitoneal (IP) injection once every 3 weeks (dd-TCip therapy). Phase B: To compare the efficacy and safety of the following two treatment regimens as first-line chemotherapy in women with epithelial ovarian, Fallopian tube or primary peritoneal cancer.

This early phase I trial studies giving propranolol hydrochloride with standard chemotherapy in treating patients with ovarian, primary peritoneal, or fallopian tube cancer. Biological therapies, such as propranolol hydrochloride, blocks certain chemicals that affect the heart and this may stimulate the immune system and allow the chemotherapy to kill more tumor cells.

Primary Objectives: o Run-in Phase: Determine a dose of EP-100 at which the initial benefit/risk of paclitaxel combined with EP-100 can be studied. o Randomized Phase: Compare the anti-tumor effects of EP-100 combined with weekly paclitaxel versus paclitaxel alone in patients with ovarian cancer. Secondary Objectives: o Randomized Phase: Quantify any significant changes in the safety profile of weekly paclitaxel alone compared to the doublet combination of paclitaxel with EP-100. o Determine an initial benefit/risk profile for this new drug combination.

Patients with extensive and bulky disease are often those whose initial surgery is delayed after 3 or 4 cycles of neo-adjuvant chemotherapy. In that case, there is, indeed, some concern to administer bevacizumab during the chemotherapy surrounding the interval debulking surgery due to the long half life (14- 21 days) of this monoclonal antibody and the interference of anti angiogenic agents with wound healing. Vargatef® (Nintedanib) might offer a better alternative to bevacizumab in the neo-adjuvant setting. Vargatef® (Nintedanib) has a much shorter half-life of 7 to 19 hours. Preliminary experience in cancer did not show a trend for increased incidence of fistula or bowel perforation. For more details please refer to the investigator drug brochure for Vargatef® (Nintedanib). This trial will compare progression-free survival and surgical complications of 188 patients with FIGO stage IIIC/IV treated in first line with either neo-adjuvant chemotherapy (carboplatin & paclitaxel) and interval debulking surgery or the same treatment + Vargatef® (Nintedanib).

In patient with a platinum sensitive ovarian cancer recurrence is demonstrated that the re-challenge with a compound of platinum-based, or a treatment with carboplatin in combination with paclitaxel , determines a rate of clinical response similar to the primary treatment, which is all the more important as the longer the time to progression from the primary therapy.In the clinical setting there are many studies that have shown activity of oxaliplatin and docetaxel in patients with advanced ovarian cancer. Two recent studies have shown clinical efficacy of the combination carboplatin / docetaxel in the first line oxaliplatin / paclitaxel to recurrence of disease, confirming the data already obtained from studies of activity in a single agent.In surgery it has been demonstrated in a meta-analysis including approximately 7000 patients in advanced stages of disease, that the extent of cytoreduction is the most powerful determinant of survival.The role of secondary surgical cytoreduction in case of recurrent disease has yet to be determined because of the lack of prospective randomized clinical studies that may highlight the superiority of such aggressive treatment.The combination of aggressive cytoreductive surgery and hyperthermic intraperitoneal intraoperative chemotherapy (CHIP) used in recent clinical studies showed a prolonged time to progression and disease-free survival in patients with ovarian cancer. However, these studies were conducted on groups of patients with very different among themselves and with other drugs, it is difficult to draw definitive conclusions.Given the activities of oxaliplatin and docetaxel and their non-cross-resistance we designed a Phase 2 clinical trial on treatment of patients with recurrent ovarian cancer, platinum-sensitive, treated with surgical cytoreduction with hyperthermic oxaliplatin-based intraoperative intraperitoneal chemotherapy and following consolidation treatment with oxaliplatin and docetaxel systemically every 21 days.

Folate binding protein (FBP) is highly over-expressed in breast, ovarian and endometrial cancers and is the source of immunogenic peptides (E39) that can stimulate cytotoxic T lymphocytes (CTL) to recognize and destroy FBP-expressing cancer cells in the laboratory. The purpose of this study is to test whether a peptide-based vaccine consisting of the E39 peptide mixed with the FDA-approved immunoadjuvant granulocyte macrophage colony-stimulating factor (GM-CSF) is safe and effective at inducing an in vivo peptide-specific immune response. Furthermore, the investigators intend to determine the best dose of the vaccine to utilize to produce this immunity most efficiently. The investigators will determine whether immunity to FBP will prevent clinical recurrence. Additionally, the investigators will compare these results with results from a trial utilizing the E75 peptide (from the HER2/neu protein) in ovarian and endometrial cancer patients in preparation for studying a combination vaccine.

Overall Design: This is a multicenter, open-label, Phase 1/2 study which will be conducted in three arms (as described below). Each arm will be conducted in two parts: a Phase 1 part which will include dose escalation and a Phase 2 part which will include four cohorts in specific disease indications. Phase 1 will also include a food effect study of E7449 as a single agent. Once the MTD in the Phase 1 single agent arm and the Phase 1 combination arms of this study has been achieved, the sponsor will submit the relevant safety information and recommended Phase 2 dose to the IRB/Health Authorities. Arm 1: E7449 will be administered as a single agent. Arm 2: E7449 will be administered in combination with TMZ. Arm 3: E7449 will be administered in combination with carboplatin and paclitaxel