NCT01459380

Pegylated Liposomal Doxorubicin Hydrochloride, Carboplatin, Veliparib, and Bevacizumab in Treating Patients With Recurrent Ovarian Cancer, Primary Peritoneal Cancer, or Fallopian Tube Cancer

Completed Phase 1 Last updated 22 July 2019

What this trial tests

Phase 1 trial testing Bevacizumab in Ovarian Clear Cell Cystadenocarcinoma in 41 participants. Completed in 11 February 2017.

Timeline

11 October 2011

Primary endpoint
8 June 2016

11 February 2017

Quick facts

Lead sponsor	National Cancer Institute (NCI)
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	41
Start date	11 October 2011
Primary completion	8 June 2016
Estimated completion	11 February 2017
Sites	13 locations across United States

Drugs / interventions tested

• Bevacizumab (Bevacizumab-Bvzr) — full drug profile →
• Carboplatin (Carboplatin) — full drug profile →
• Laboratory Biomarker Analysis — full drug profile →
• Pegylated Liposomal Doxorubicin Hydrochloride — full drug profile →
• Veliparib

Conditions studied

• Ovarian Clear Cell Cystadenocarcinoma — all drugs for Ovarian Clear Cell Cystadenocarcinoma →
• Ovarian Endometrioid Adenocarcinoma — all drugs for Ovarian Endometrioid Adenocarcinoma →
• Ovarian Seromucinous Carcinoma — all drugs for Ovarian Seromucinous Carcinoma →
• Ovarian Serous Cystadenocarcinoma — all drugs for Ovarian Serous Cystadenocarcinoma →

Sponsor

National Cancer Institute (NCI)

Who can join

18 and older, female only, with Ovarian Clear Cell Cystadenocarcinoma or Ovarian Endometrioid Adenocarcinoma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This phase I trial studies the side effects and the best dose of veliparib when given together with pegylated liposomal doxorubicin hydrochloride, carboplatin, and bevacizumab in treating patients with ovarian cancer, primary peritoneal cancer, or fallopian tube cancer that has returned after previous treatment. Veliparib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as pegylated liposomal doxorubicin hydrochloride and carboplatin, may stop the growth of tumor cells by, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Monoclonal antibodies, such as bevacizumab, can block tumor growth by blocking the ability of tumor cells to grow and spread. Bevacizumab may also stop the growth of tumors by blocking the growth of new blood vessels necessary for tumor growth. Giving veliparib together with pegylated liposomal doxorubicin hydrochloride, carboplatin, and bevacizumab may kill more tumor cells.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Exploring and comparing adverse events between PARP inhibitors.
   LaFargue CJ, Dal Molin GZ, Sood AK, Coleman RL. · · 2019 · cited 367× · PMID 30614472 · DOI 10.1016/s1470-2045(18)30786-1
2. Targeting DNA damage response in cancer therapy.
   Hosoya N, Miyagawa K. · · 2014 · cited 232× · PMID 24484288 · DOI 10.1111/cas.12366
3. PARP inhibitors for BRCA1/2-mutated and sporadic ovarian cancer: current practice and future directions.
   Konecny GE, Kristeleit RS. · · 2016 · cited 155× · PMID 27736844 · DOI 10.1038/bjc.2016.311
4. Combination Platinum-based and DNA Damage Response-targeting Cancer Therapy: Evolution and Future Directions.
   Basourakos SP, Li L, Aparicio AM, Corn PG, et al · · 2017 · cited 91× · PMID 27978798 · DOI 10.2174/0929867323666161214114948
5. Current status and future prospects of PARP inhibitor clinical trials in ovarian cancer.
   Jiang X, Li W, Li X, Bai H, et al · · 2019 · cited 75× · PMID 31191001 · DOI 10.2147/cmar.s200524
6. Current Ovarian Cancer Maintenance Strategies and Promising New Developments.
   Gogineni V, Morand S, Staats H, Royfman R, et al · · 2021 · cited 54× · PMID 33391401 · DOI 10.7150/jca.49406
7. The Role of PARP Inhibitors in the Treatment of Gynecologic Malignancies.
   Reinbolt RE, Hays JL. · · 2013 · cited 43× · PMID 24098868 · DOI 10.3389/fonc.2013.00237
8. BRCA 1/2-Mutation Related and Sporadic Breast and Ovarian Cancers: More Alike than Different.
   Burgess M, Puhalla S. · · 2014 · cited 34× · PMID 24579064 · DOI 10.3389/fonc.2014.00019