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A Phase 2, Open-Label, Safety and Efficacy Study of Panzem® Nanocrystal Colloidal Dispersion Administered Orally in Patients With Recurrent or Resistant Epithelial Ovarian Cancer


Phase 2
18 Years
N/A
Not Enrolling
Female
Ovarian Cancer

Thank you

Trial Information

A Phase 2, Open-Label, Safety and Efficacy Study of Panzem® Nanocrystal Colloidal Dispersion Administered Orally in Patients With Recurrent or Resistant Epithelial Ovarian Cancer


Inclusion Criteria:



1. Written informed consent and HIPAA authorization for release of protected health
information.

2. Have histologically-confirmed:

- epithelial ovarian cancer or

- primary peritoneal carcinomatosis or

- fallopian tube cancer. Enrollment of patients with clear cell histology is
encouraged.

3. Have measurable disease according to RECIST or detectable disease by 1) CA-125 at
least twice the ULN within 14 days prior to registration for protocol therapy; 2)
Ascites and/or pleural effusion attributed to tumor; 3) solid and/or cystic
abnormalities on radiographic imaging that do not meet RECIST definitions for target
lesions. Radiographic assessments must be obtained within 28 days prior to
registration for protocol therapy.

4. Be 18 years of age or older at the time of consent.

5. Be at least 4 weeks since last anti-cancer treatment, radiation or surgery at the
time of registration for protocol therapy (with the exception of hormonal therapy,
where a 1 week wash-out period is sufficient; minor surgeries, such as catheter
placement or removal within 1 week from enrollment are allowed).

6. Have failed at least one prior platinum based chemotherapeutic regimen. (Platinum
failure is defined as Platinum-refractory (progression while receiving a
platinum-containing regimen) or platinum-resistant (disease progression within 6
months from completion of platinum-containing regimen).

7. Have life expectancy of at least 3 months.

8. Have ECOG performance status of 0 or 1 as assessed within 14 days prior to
registration for protocol therapy.

9. Have near-normal organ function, as evidenced by laboratory data within 14 days prior
to registration for protocol therapy:

- Aspartate aminotransferase and alanine aminotransferase less than 2.5 times
upper limit of normal (ULN)

- Total bilirubin less than 1.5 times ULN

- Alkaline phosphatase less than 2.5 times ULN

- Absolute neutrophil count greater than or equal to 1,500 cells/mm3

- White blood cell count greater than or equal to 3,000 cells/mm3

- Hemoglobin greater than or equal to 9.0 g/dL

- Platelets greater than 75,000/mm3

- Creatinine levels less than 1.5 times ULN

10. Have no evidence of bowel obstruction, malabsorption, or other contraindication to
oral medication.

11. Females of childbearing potential must be willing to use an effective method of
contraception (hormonal or barrier method of birth control; abstinence) while on
treatment.

12. Females of childbearing potential must have a negative pregnancy test within 7 days
prior to being registered for protocol therapy. Subjects are considered not of
childbearing potential if they are surgically sterile (they have undergone a
hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or they are
postmenopausal.

Exclusion Criteria:

1. Be breastfeeding.

2. Have any condition that is likely to interfere with regular follow-up.

3. Have a history of myocardial infarction or angina pectoris or angina equivalent
within 6 months prior to registration for protocol therapy (the patient may be on
anti-anginal medications if the symptoms can be entirely controlled), or have
uncontrolled hypertension or congestive heart failure.

4. Have participated in any clinical trial involving conventional or investigational
drugs or devices within 4 weeks prior to registration for protocol therapy.

5. Have had any active cancer in addition to the epithelial ovarian cancer within the
last 5 years, with the exception of:

- superficial skin cancer (basal cell or squamous cell skin carcinoma)

- carcinoma in situ of the cervix

- Stage I endometrial cancer with less than 50% invasion of the myometrium, or

- other adequately treated Stage I or II cancer in complete remission.

6. Have an active infection requiring antibiotic treatment.

7. Be receiving concurrent anticoagulation therapy (low dose coumadin for port-a-cath
maintenance is allowed).

8. Have any additional uncontrolled serious medical condition or psychiatric illness.

9. Be receiving combination anti-retroviral therapy for the treatment of
immunodeficiency.

10. Have brain metastases

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Assess the safety of oral doses of Panzem NCD administered to patients with recurrent epithelial ovarian cancer

Outcome Time Frame:

Throughout study participation

Safety Issue:

Yes

Principal Investigator

Daniela E. Matei, M.D.

Investigator Role:

Study Chair

Investigator Affiliation:

Indiana University School of Medicine

Authority:

United States: Food and Drug Administration

Study ID:

ME-CLN-004

NCT ID:

NCT00400348

Start Date:

October 2006

Completion Date:

November 2008

Related Keywords:

  • Ovarian Cancer
  • Ovarian Neoplasms

Name

Location

Indiana University Cancer CenterIndianapolis, Indiana  46202-5265