Neoplasms

All Conditions

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

Rare Diseases

Carcinoma

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Fallopian Tube Neoplasms

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

Fallopian Tube Diseases

Ovarian Cancer

Ovarian Epithelial Cancer

Fallopian Tube Cancer

Gastrointestinal Agents

All Drugs and Chemicals

Alvimopan

Perioperative administration of oral alvimopan, 12mg twice daily, starting with 1 dose preoperative. Drug was continued for duration of hospital stay, but did not exceed 7 days.

Perioperative administration of placebo, at same dosing interval as study drug.

Perioperative administration of oral alvimopan, 12mg twice daily, starting with 1 dose preoperative.

Placebo

Jamie Bakkum-Gamez, MD

This study is designed to determine whether an oral perioperative medication (alvimopan--a selective mu antagonist) improves bowel recovery over placebo after surgery for ovarian cancer.

Accelerating Gastrointestinal Recovery

Accelerating Gastrointestinal Recovery in Women Undergoing Staging and/or Debulking Surgery for Epithelial Ovarian, Fallopian Tube, and Primary Peritoneal Carcinoma: A Randomized, Double-Blind, Placebo-Controlled Trial

Length of stay = date/time of hospital dismissal - date/time of end of surgery

Ileus was defined as MD-diagnosed, return to nothing by mouth (NPO) status, or insertion of nasogastric tube for ileus.

Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

Jamie N. Bakkum-Gamez

Consultant and Assistant Professor of Obstetrics-Gynecology,

Perioperative administration of oral placebo, at same dosing interval as study drug, starting with one dose preoperative. Drug was continued for duration of hospital stay, but did not exceed 7 days..

Total

Age, Continuous

Sex: Female, Male

United States

Region of Enrollment

Primary surgery

Interval debulking

Secondary debulking

Surgery Type

I/II

III/IV

Other non-ovarian primary cancers

Benign pelvic masses

Recurrent disease

Cancer Stage used the Fédération Internationale de Gynécologie et d'Obstétrique (FIGO) staging system. For ovarian cancer, there are 4 stages: stage I: confined to the organ of origin, stage II: invasion of surrounding organs or tissue, stage III: spread to distant nodes or tissue within the pelvis, stage IV: distant metastasis(es)

Cancer Stage

Yes, measurable (</= 1 cm)

Yes, suboptimal (>1 cm, limited sites)

Yes, extensive (multiple sites/organs)

Residual Disease

Baseline characteristics are provided for the subjects who completed study follow up.

Dr. Jamie N. Bakkum-Gamez

Postoperative Length of Hospital Stay

Postoperative Ileus Incidence

Overall Study

Endocrine Gland Neoplasms

Ovarian Diseases

Endocrine System Diseases

Gonadal Disorders

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Anti-Inflammatory Agents

Antirheumatic Agents

Analgesics

Ketorolac

Ketorolac Tromethamine

Anti-Inflammatory Agents, Non-Steroidal

Analgesics, Non-Narcotic

Cyclooxygenase Inhibitors

Enzyme Inhibitors

Once deemed stable in the first 1-3 post-operative days, patients will be receive age-based ketorolac (30 mg \<65, 15mg \> 65) daily for three days

Once deemed stable in the first 1-3 post-operative days, patients will be receive placebo daily for three days

Ketorolac tromethine 15 mg or 30 mg doses will be administered via intravenous (IV) push undiluted over 15 - 30 seconds

Ketorolac will be dosed according to FDA approved recommendations. For planned three daily dose (IV) based on clinical scenario:

* Patients \< 65 years of age: Daily dose of 30 mg for three doses.
* Patients ≥ 65 years of age, renally impaired and/or less than 50 kg (110 lbs) of body weight: Daily dose of 15 mg for three doses

Blood and peritoneal fluid will be drawn prior to each dose (time 0, 24, 48, 72 hr) as well as at 6 hr after the first dose

Equivalent volume of normal saline will be set in the syringe for each daily dose registered for the patient in a blinded fashion. The volume will be determined by the dose calculation as follows: For planned three daily dose (IV) based on clinical scenario:

* Patients \< 65 years of age: Daily dose of 30 mg for three doses.
* Patients ≥ 65 years of age, renally impaired and/or less than 50 kg (110 lbs) of body weight: Daily dose of 15 mg for three doses.

Blood and peritoneal fluid will be drawn prior to each dose (time 0, 24, 48, 72 hr) as well as at 6 hr after the first dose

Carolyn Y. Muller, MD

There is a move towards personalized medicine in cancer care, and significant effort is underway to evaluate new targeted therapeutics for the treatment of ovarian cancer. One way to identify potential new drug targets is by screening a drug library to determine whether drugs in the library target key kinase or enzymatic sites in cellular signaling pathways. Previous preclinical work and pilot studies demonstrated that ketorolac (a type of non-steroidal anti-inflammatory drug) inhibits GTPase activity in ovarian cancer cells retrieved from the post-operative peritoneal cavity.

The purpose of this study is to confirm that this inhibitory effect is ketorolac driven and not a specific effect of the post-operative peritoneal compartment.

Drug repurposing, screening a library of FDA approved agents, can identify agents that are clinically available and for which pharmacology and pharmacokinetics are known and preclinical data can be generated rapidly without the subsequent need for GMP (good manufacturing practice) new drug production. Small GTPases, including members of the Rab, Ras and Rho families, are attractive targets for the development of cancer therapeutics based on their pivotal roles in protein trafficking, proliferation/survival and cytoskeletal organization, respectively. Ketorolac tromethamine is a non-steroidal anti-inflammatory drug that was identified in previous in-silico drug screens to be an inhibitor of GTPases. In a previous phase 0 clinical study, ketorolac was administered intravenously to ovarian cancer patients following optimal cytoreductive surgery. Ovarian cancer cells were obtained at the time of surgery, prior to ketorolac administration, and at various times after ketorolac dosing. Analysis of GTPase activity in these specimens showed a time-dependent inhibition of Rac1 and Cdc42 GTPase activity. The purpose of this study is to confirm that the effect is ketorolac driven and not a specific effect of the post-operative peritoneal compartment.

Evaluation of GTPase Inhibition by Post-operative Intravenous Ketorolac in Ovarian Cancer Patients

A Randomized Placebo-controlled Evaluation of GTPase Inhibition by Post-operative Intravenous Ketorolac in Ovarian Cancer Patients

Time from treatment to death due to any cause

Time from treatment to progressive disease or death due to any cause

Ovarian cancer cells retrieved from the post-debulked peritoneal cavity after three intravenous dosings of ketorolac will be evaluated for GTPase activity using cell-based laboratory assays

Serum and intraperitoneal concentrations of ketorolac will be assessed over time using high performance liquid chromatography (HPLC)

CA-125 will be measured using a standard laboratory assay

Subjective/objective evidence of developing drug toxicity will be evaluated according to NCI-CTC toxicity criteria (CTCAE version 3.0)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Accelerating Gastrointestinal Recovery	NCT01704651	Ovarian Cancer Fallopian Tube ... Peritoneal Canc...	Alvimopan Placebo	18 Years -	Mayo Clinic
Evaluation of GTPase Inhibition by Post-operative Intravenous Ketorolac in Ovarian Cancer Patients	NCT02470299	Ovarian Cancer Fallopian Tube ... Peritoneal Canc...	Ketorolac Placebo	18 Years -	New Mexico Cancer Care Alliance

Spots Global Cancer Trial Database for fallopian

Every month we try and update this database with for fallopian cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for fallopian

Every month we try and update this database with for fallopian cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for fallopian cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.