Know Cancer

or
forgot password

Feasibility Study: Therapeutic Targeting of Stress Factors in Ovarian Cancer Patients


Phase 0
18 Years
N/A
Open (Enrolling)
Female
Invasive Epithelial Ovarian Cancer, Primary Peritoneal Carcinoma, Fallopian Tube Cancer

Thank you

Trial Information

Feasibility Study: Therapeutic Targeting of Stress Factors in Ovarian Cancer Patients

Inclusion Criteria


Preoperative Eligibility Criteria:

Inclusion Criteria

- Suspected preoperative diagnosis of invasive ovarian cancer, primary peritoneal
carcinoma, fallopian tube cancer based on imaging and CA-125 levels

- Patients must scheduled for a planned tumor debulking at least 72 hours in advance in
order for the patient to take at least 48 hours of prescribed Propranolol

- Intention for chemotherapy administration at Washington University

- An approved informed consent and authorization permitting release of personal health
information must be signed by patient or guardian

- Age ≥ 18 years

- Gynecologic Oncology Group performance status 0-2

- Patient's of childbearing age must have a negative pregnancy test

Exclusion Criteria

- Patients who receive neoadjuvant chemotherapy for their ovarian, primary peritoneal,
or fallopian tube cancer are excluded.

- Patients with a prior diagnosis of a borderline tumor that was surgically resected
and who subsequently develop an unrelated new invasive epithelial ovarian, primary
peritoneal, or fallopian tube cancer are eligible, provided that they have not
received chemotherapy for any tumor

- Patients who have received prior radiotherapy to any portion of the abdominal cavity
or pelvis are excluded. Prior radiation therapy for localized cancer of the breast,
head and neck, or skin is permitted provided that it was completed more than 3 years
prior to registration, and the patient remains free of recurrent or metastatic
disease

- Patients with a past history of primary endometrial cancer are excluded unless all of
the following conditions are met: stage not greater than stage IA; no more than
superficial myometrial invasion, without vascular or lymphatic invasion; no poorly
differentiated subtypes, including papillary serous, clear cell, or other FIGO grade
3 lesions.

- With the exception of non-melanoma skin cancer and other specific malignancies as
noted above, patients with other invasive malignancies who had (or have) any evidence
of the other cancer present with the last five years or whose previous cancer
treatment contraindicates this protocol therapy are excluded.

- Use of systemic glucocorticoids such as Prednisone or Decadron in the last month

- Inability to accurately answer questions (e.g. dementia, brain metastases) or speak
English

- Cirrhosis of the liver

- Patients with a GOG Performance status 3 or 4

- Patients under the age of 18

- Comorbid conditions: Addison's disease, autoimmune hepatitis, hepatitis B, hepatitis
C, AIDS or HIV, lupus erythematosus, mixed connective tissue disease, rheumatoid
arthritis

- Any patients already on beta-blockers or contraindicated to receive beta-blockers

Post-operative Eligibility Criteria:

Inclusion Criteria

- Histologic diagnosis of invasive epithelial ovarian cancer, primary peritoneal
carcinoma, fallopian tube cancer. Histologic epithelial cell types are eligible:
serous adenocarcinoma, endometrioid adenocarcinoma, mucinous adenocarcinoma,
undifferentiated carcinoma, clear cell carcinoma, mixed epithelial carcinoma, or
adenocarcinoma not otherwise specified. However, the histologic features must be
compatible with primary Müllerian epithelial adenocarcinoma. Patients with low grade
invasive epithelial ovarian cancers may participate.

- Stages I-IV of the above cancer

- Patients having undergone a suboptimal or optimal tumor debulking

- Gynecologic Oncology Group performance status 0-2

- Patients must have adequate:

1. Bone marrow function: Absolute neutrophil count (ANC) greater than or equal to
1500/ml.

2. Platelets greater than 100,000/ml

3. Renal function: Creatinine ≤ 1.5 x institutional upper limit normal

4. Hepatic function: Bilirubin less than or equal to 1.5 x institutional upper
limit normal; SGOT and alkaline phosphatase less than or equal to 2.5 x
institutional upper limit normal.

5. Neurologic function: Neuropathy (sensory and motor) less than or equal to grade
1 according to Common Toxicity Criteria for Adverse Events version 3 (CTCAE).

6. Blood coagulation parameters: PT such that international normalized ratio (INR)
is ≤1.5 (or an in-range INR, usually between 2 and 3, if a patient is on a
stable dose of therapeutic warfarin for the management of venous thrombosis
including pulmonary embolus) and a PTT <1.2 times institutional upper limit of
normal.

Exclusion Criteria

- Patients who have received targeted therapy (including but not limited to vaccines,
antibodies, tyrosine kinase inhibitors) or hormonal therapy for management of their
primary peritoneal, ovarian, or fallopian tube cancer. Patients cannot receive
concurrent bevacizumab or other targeted therapy as part of their primary
chemotherapy.

- Patients with non-epithelial ovarian tumors that do not require adjuvant
chemotherapy, borderline epithelial ovarian tumor, or recurrent invasive epithelial
ovarian, low grade ovarian cancer, primary peritoneal, or fallopian tube cancer
treated with surgery only (such as patients with stage IA or IB)

- Patients with a synchronous primary endometrial cancer are excluded unless all of the
following conditions are met: stage not greater than stage IA; no more than
superficial myometrial invasion, without vascular or lymphatic invasion; no poorly
differentiated subtypes, including papillary serous, clear cell, or other FIGO grade
3 lesions

- Metastases to the ovaries from other organs except fallopian tube or primary
peritoneal carcinoma

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Feasibility of concurrent beta-blocker administration with chemotherapy

Outcome Description:

Proportion of patients who successfully complete 6 cycles of chemotherapy and concurrent treatment with propranolol

Outcome Time Frame:

Completion of 6 cycles of chemotherapy/propranolol

Safety Issue:

No

Principal Investigator

Premal Thaker, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Washington University School of Medicine

Authority:

United States: Institutional Review Board

Study ID:

10-0447 / 201104047

NCT ID:

NCT01308944

Start Date:

August 2010

Completion Date:

December 2013

Related Keywords:

  • Invasive Epithelial Ovarian Cancer
  • Primary Peritoneal Carcinoma
  • Fallopian Tube Cancer
  • invasive epithelial ovarian cancer,
  • primary peritoneal carcinoma,
  • fallopian tube cancer
  • Carcinoma
  • Ovarian Neoplasms
  • Fallopian Tube Neoplasms
  • Neoplasms, Glandular and Epithelial

Name

Location

Washington University in St. LouisSt. Louis, Missouri  63110