Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

All Conditions

Rare Diseases

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Carcinoma

Endocrine Gland Neoplasms

Ovarian Diseases

Adnexal Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Genital Neoplasms, Female

Urogenital Neoplasms

Endocrine System Diseases

Gonadal Disorders

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Ovarian Cancer

Ovarian Epithelial Cancer

Antineoplastic Agents

All Drugs and Chemicals

Anti-Infective Agents

Doxorubicin

Liposomal doxorubicin

Nintedanib

Anti-Bacterial Agents

Antibiotics, Antitubercular

Enzyme Inhibitors

Protein Kinase Inhibitors

Phases I and II: 40 mg/m2 IV over 60 min (+/- 15 min) on day 1 of 28-day cycle

Doxil (Pegylated Liposomal Doxorubicin)

Phase I: Escalating cohorts days -2 through +2, orally 100mg bid, 150mg bid, 200mg bid

Phase II: MTD orally, bid, day 2 of 28-day cycle

BIBF 1120

Daniela Matei, M.D.

The purpose of this trial is to determine whether BIBF 1120 can be safely combined with pegylated liposomal doxorubicin (phase I), and to determine the clinical activity of the combination in patients with platinum-resistant ovarian cancer (phase II).

OUTLINE: This is a phase I/II multi-center study.

Phase I:

All patients will receive a fixed dose of pegylated liposomal doxorubicin (Doxil) of 40 mg/m2 administered IV every 28 days. The dose of BIBF 1120 will be escalated in successive cohorts of patients. A maximum of 12 cycles of combined therapy will be administered corresponding to maximum cumulative dose of PLD of 480 mg/m2. Continuation therapy with single agent BIBF 1120 may continue for selected patients.

The escalation phase will follow the standard 3+3 design. Patients will be accrued to each dose level in cohorts of up to 3-6 evaluable patients. Escalation will continue until a DLT is observed, the highest dose level is reached, or medical judgment indicates. An expansion cohort of 3 to 6 patients will be treated at the MTD (or highest dose level if the MTD is not reached), in order to ensure tolerability of the regimen prior to initiating the Phase II component of the study.

Phase II:

Patients will receive a fixed dose of pegylated liposomal doxorubicin (Doxil) of 40 mg/m2 administered IV every 28 days. Patients will be treated at either dose Level +2 or the MTD dose level of BIBF 1120 as defined by the Phase I cohort. Each cycle will be 28 days. Patients will continue treatment with the combination therapy for a total of up to 12 cycles.

ECOG Performance Status 0-1

Life Expectancy: Not specified

Hematopoietic:

* Absolute neutrophil count ≥ 1500 cells/mm3
* White cell blood count ≥ 3000 cells/mm3
* Hemoglobin ≥ 9.0 g/dL (can be post-transfusion)
* Platelets ≥ 100,000/mm3 (can not be post-transfusion)

Hepatic:

* Aspartate aminotransferase and alanine aminotransferase less than or equal to 2.5 times upper limit of normal (ULN)
* Total serum bilirubin ≤ 1.5 times ULN
* Alkaline phosphatase ≤ 2.5 times ULN

Renal:

* Creatinine levels ≤ 1.5 times ULN

Cardiovascular:

* Baseline left ventricular ejection fraction greater than 50%
* International Normalized ratio(INR) ≤ 1.5 times ULN, except patients on stable doses of coumadin or low molecular weight heparin NOTE: Patients on stable doses of coumadin or low molecular weight heparin are eligible if anticoagulant doses have been stable and no bleeding complications were recorded.
* Partial thromboplastin time (PTT) ≤1.5 times ULN

This study was terminated due to drug availability and Phase II never opened.

Doxorubicin + BIBF 1120 in Patients for Ovarian Cancer

A Phase I-II Clinical Trial of Pegylated Liposomal Doxorubicin (Doxil®) in Combination With BIBF 1120 in Patients With Ovarian Cancer: Hoosier Oncology Group GYN10-149

To find the maximum tolerated dose (MTD) to be used during the Phase II trial and evaluate the safety and toxicity of the combination BIBF 1120 plus PLD in patients with recurrent or resistant epithelial ovarian or endometrial cancer.

To assess response rate (objective response) in patients with recurrent or resistant epithelial ovarian cancer treated with BIBF 1120 plus PLD.

To determine the progression-free survival of Phase I and II patients with recurrent or resistant epithelial ovarian cancer treated with BIBF 1120 plus PLD.

To determine the rate of clinical benefit for Phase I and II defined as:

* the number of patients experiencing an objective response or
* a CA125 response, in the absence of disease progression by clinical or radiographic criteria
* sustained stable disease ≥ 3 months by clinical and radiographic criteria

Boehringer Ingelheim

Hoosier Cancer Research Network

Spots Global Cancer Trial Database for doxil (pegylated liposomal doxorubicin)