Study on Durvalumab with Chemotherapy for Treating Advanced Ovarian Cancer

Sponsor: M.D. Anderson Cancer Center

Sponsor score: 0

ClinicalTrials ID:NCT02726997

Provider View

This clinical trial is testing how well the drug durvalumab works when combined with chemotherapy drugs carboplatin and paclitaxel in treating patients with advanced ovarian, primary peritoneal, or fallopian tube cancer. The study aims to see if this combination can help the immune system fight cancer more effectively.

Patient Parameters

Program Overview

This study is exploring the effectiveness of combining durvalumab, an immunotherapy drug, with chemotherapy drugs carboplatin and paclitaxel for treating advanced ovarian, primary peritoneal, or fallopian tube cancer. Immunotherapy like durvalumab may help the immune system attack cancer cells, while chemotherapy drugs work to stop cancer cells from growing and spreading. The goal is to see if this combination can provide a better treatment option for these types of cancer.

Description

The study is divided into several parts:

  1. Neoadjuvant Chemotherapy: Before surgery, patients will receive durvalumab and carboplatin through an IV on day 1, and paclitaxel through an IV on days 1, 8, and 15. This treatment cycle repeats every 21 days for up to 3 cycles, unless the cancer progresses or side effects become too severe. After these cycles, patients will have surgery to remove as much of the cancer as possible.

  2. Surgery: After completing the initial chemotherapy cycles, patients will undergo surgery to remove cancerous tissue.

  3. Adjuvant Therapy: After surgery, patients will continue to receive carboplatin and paclitaxel, along with durvalumab, in a similar schedule as before surgery. This will also repeat every 21 days for up to 3 cycles.

  4. Maintenance Therapy: Patients will receive durvalumab every 28 days for up to 7 cycles, as long as the cancer does not progress and side effects are manageable.

After completing the study treatment, patients will have follow-up visits at 30 days, then at 2, 3, 4, 6, 8, 9, 10, and 12 months, and every 6 months thereafter to monitor their health and the effectiveness of the treatment.

Eligibility Criteria

Inclusion Criteria

  • Must provide written informed consent before participating.
  • Diagnosed with high-grade epithelial non-mucinous ovarian, primary peritoneal, or fallopian tube cancer.
  • No prior treatment for advanced stage III or IV cancer.
  • Planned to receive neoadjuvant chemotherapy followed by surgery.
  • Must have measurable disease based on specific medical criteria.
  • Good overall health with a performance status of 0 or 1.
  • Life expectancy of at least 12 weeks.
  • Meet specific blood count and organ function requirements.
  • Women must not be pregnant and must agree to use effective contraception.
  • Willing to comply with study procedures and follow-up visits.
  • Provide a tumor tissue sample for research purposes.

Exclusion Criteria

  • Involvement in planning or conducting the study.
  • Previous enrollment in this study.
  • Prior treatment for ovarian, fallopian tube, or primary peritoneal cancer.
  • Diagnosed with mucinous or low-grade epithelial carcinoma.
  • Participation in another clinical study within the last 4 weeks.
  • Previous treatment with PD1 or PD-L1 inhibitors.
  • History of another primary cancer unless treated and inactive for 5 years.
  • Certain heart conditions or use of immunosuppressive medication.
  • Unresolved side effects from previous cancer treatments.
  • Active autoimmune or inflammatory diseases.
  • History of organ transplant or primary immunodeficiency.
  • Allergies to study drugs or their components.
  • Uncontrolled illnesses or infections.
  • Pregnant or breastfeeding women.
  • Uncontrolled brain metastases or seizures.

Locations

FACILITYZIPCITYSTATE
M D Anderson Cancer Center77030HoustonTexas

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