Intravenous and Intraperitoneal Paclitaxel, Intraperitoneal Cisplatin, and Intravenous Bevacizumab for the Initial Treatment of Optimal Stage II or III Ovarian, Primary Peritoneal, and Fallopian Tube Cancer

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00588237
• Date of registration: 22/12/2007
• Primary sponsor: Memorial Sloan-Kettering Cancer Center
• Public title: Intravenous and Intraperitoneal Paclitaxel, Intraperitoneal Cisplatin, and Intravenous Bevacizumab for the Initial Treatment of Optimal Stage II or III Ovarian, Primary Peritoneal, and Fallopian Tube Cancer
• Scientific title: A Phase II Study of Intravenous and Intraperitoneal Paclitaxel, Intraperitoneal Cisplatin, and Intravenous Bevacizumab for the Initial Treatment of Optimal Stage II or III Ovarian, Primary Peritoneal, and Fallopian Tube Cancer
• Date of first enrolment: August 2006
• Target sample size: 42
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00588237
• Study type: Interventional
• Study design: Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Countries of recruitment

United States

Contacts

• Name: Jason Konner, MD
• Affiliation: Memorial Sloan-Kettering Cancer Center

Key inclusion & exclusion criteria

Inclusion Criteria:

- Subjects must have signed an approved informed consent.

- Subjects with histologic diagnosis of epithelial ovarian carcinoma, primary
peritoneal carcinoma, or fallopian tube carcinoma, Stage II or III, with optimal (=
or equal to 1 cm residual disease) residual disease following initial surgery. All
subjects must have had appropriate surgery for ovarian, primary peritoneal, or
fallopian tube carcinoma with appropriate tissue available for histologic evaluation
to confirm diagnosis and stage. Pathology must be verified at Memorial
Sloan-Kettering Cancer Center.

- Subjects with the following histologic epithelial cell types are eligible: Serous
adenocarcinoma, endometrioid adenocarcinoma, mucinous adenocarcinoma,
undifferentiated carcinoma, clear cell adenocarcinoma, mixed epithelial carcinoma,
transitional cell carcinoma, malignant Brenner's Tumor, or adenocarcinoma N.O.S.

- Subjects must have a Karnofsky Performance Status (KPS) of = or equal to 70%.

- Subjects must be entered no more than 12 weeks postoperatively.

- Bone marrow function:

- Absolute neutrophil count (ANC) = than or equal to 1,500/µl (equivalent to Common
Toxicity Criteria (CTC) Grade 1)

- Platelets = than or equal to 100,000/µl (CTC Grade 0-1)

- Renal function: Creatinine = than or equal to 1.5 mg/dl

- Hepatic function: Bilirubin = than or equal to 1.5 x ULN (CTC Grade 1) AST = than or
equal to 2.5 x ULN (CTC Grade 1)

- Neurologic function:Neuropathy (sensory) = than CTC Grade 1

- Urine Protein Creatinine: Urine protein creatinine (UPC) ratio must be < than 1.0 gm.
If UPC ratio > than or equal to 1, collection of 24-hour urine measurement of urine
protein is recommended as part of the patient's medical management off-study. *

- UPC ratio of spot urine is an estimation of the 24 urine protein excretion - a UPC
ratio of 1 is roughly equivalent to a 24-hour urine protein of 1 gm. UPC ratio is
calculated using one of the following formulas:

- [urine protein]/[urine creatinine] - if both protein and creatinine are reported in
mg/dL

- [(urine protein) x0.088]/[urine creatinine] - if urine creatinine is reported in
mmol/L

- The UPCR has been found to correlate directly with the amount of protein excreted in
a 24 hour urine collection. Specifically, a UPCR of 1.0 is equivalent to 1.0 gram of
protein in a 24 hour urine collection. Obtain at least 4 ml of a random urine sample
in a sterile container (does not have to be a 24 hour urine). Send sample to lab with
request for urine protein and creatinine levels [separate requests]. The lab will
measure protein concentration (mg/dL) and creatinine concentration (mg/dL). The UPCR
is derived as follows: protein concentration (mg/dL)/creatinine (mg/dL). Patients
must have a UPCR < 1.0 to allow participation in the study.

- Blood coagulation parameters:

PT such that international normalized ratio (INR) is < than or equal to 1.5 (or an
in-range INR, usually between 2 and 3, if a patient is on a stable dose of therapeutic
warfarin) and a PTT < 1.2 times the upper limit of normal.

- Patients of childbearing potential must have a negative serum pregnancy test prior to
study entry and be practicing an effective form of contraception during the study and
for at least 6 months after receiving the final treatment of bevacizumab.

- Patients must have an Intraperitoneal (IP) port in place. If a patient does not have
an IP port, she must be willing to undergo surgical placement of one.

Exclusion Criteria:

- Subjects with a current diagnosis of epithelial ovarian tumor of low malignant
potential (borderline carcinomas) are not eligible. Subjects with a prior diagnosis
of a low malignant potential tumor that was surgically resected and who subsequently
develop invasive adenocarcinoma are eligible, provided that they have not received
prior chemotherapy for any ovarian tumor.

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

- Subjects who have received prior chemotherapy for any abdominal or pelvic tumor are
excluded. Subjects may have received prior adjuvant chemotherapy for localized breast
cancer, provided that it was completed more than 3 years prior to enrollment, and
that the subject remains free of recurrent or metastatic disease.

- Patients with synchronous primary endometrial cancer, or a history of primary
endometrial cancer, are excluded unless all of the following conditions are met:

1. Stage not greater than IB.

2. Less than 3 mm invasion without vascular or lymphatic invasion

3. No poorly differentiated subtypes, including papillary serous, clear cell or
other FIGO grade 3 lesions

- Patients with suboptimal (> 1 cm) residual disease, as determined by the operative
surgeon.

- Patients who have received any targeted therapy (including but not limited to
vaccines, antibodies, tyrosine kinase inhibitors) or hormonal therapy for management
of their ovarian, peritoneal primary, or fallopian tube cancer.

- With the exception of non-melanoma skin cancer and other specific malignancies as
noted above, subjects with other invasive malignancies who had (or have) any evidence
of the other cancer present within the last 5 years or whose previous cancer
treatment contraindicates this protocol therapy are excluded.

- Subjects with acute hepatitis.

- Subjects with active infection that requires parenteral antibiotics.

- Patients with serious, non-healing wound, ulcer, or bone fracture are not eligible.
This includes history of abdominal fistula, gastrointestinal perforation or
intra-abdominal abscess within 28 days. Patients with granulating incisions healing
by secondary intention with no evidence of fascial dehiscence or infection are
eligible but require weekly wound examinations.

- Patients with active bleeding or pathologic conditions that carry high risk of
bleeding, such as known bleeding disorder, coagulopathy, or tumor involving major
vessels.

- Patients with history or evidence upon physical examination of CNS disease, including
primary brain tumor, seizures not controlled with standard medical therapy, any brain
metastases, or history of cerebrovascular accident (CVA, stroke), transient ischemic
attack (TIA) or subarachnoid h


Age minimum: 18 Years
Age maximum: N/A
Gender: Female

Health Condition(s) or Problem(s) studied

Fallopian Tube Cancer

Ovarian Cancer

Primary PERITONEUM

Intervention(s)

Drug: Paclitaxel,Cisplatin, Bevacizumab

Primary Outcome(s)

evaluate safety & tolerability of delivering 6 cycles of IV/IP paclitaxel, IP cisplatin, & IV bevacizumab (begun in cycle 2 & continued for a maximum of 22 cycles), as upfront tx in women with optimally debulked stage II/III ovarian,primary periton [Time Frame: conclusion of study]

Secondary Outcome(s)

To determine the progression-free survival. [Time Frame: conclusion of study]

Secondary ID(s)

06-064

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Genentech