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A Phase I Trial of Intravenous Paclitaxel, Intraperitoneal Carboplatin and Intraperitoneal Paclitaxel or Intravenous Docetaxel, Intraperitoneal Carboplatin and Intraperitoneal Paclitaxel or Intravenous Paclitaxel, Intraperitoneal Carboplatin, Intraperitoneal Paclitaxel and CTEP-Supplied Agent Bevacizumab (NSC 704865, IND 7921) in Patients With Previously Untreated Ovarian, Fallopian Tube or Primary Peritoneal Carcinoma


Phase 1
18 Years
N/A
Not Enrolling
Female
Brenner Tumor, Fallopian Tube Cancer, Ovarian Carcinosarcoma, Ovarian Clear Cell Cystadenocarcinoma, Ovarian Endometrioid Adenocarcinoma, Ovarian Mixed Epithelial Carcinoma, Ovarian Mucinous Cystadenocarcinoma, Ovarian Serous Cystadenocarcinoma, Ovarian Undifferentiated Adenocarcinoma, Primary Peritoneal Cavity Cancer, Stage II Ovarian Epithelial Cancer, Stage III Ovarian Epithelial Cancer, Stage IV Ovarian Epithelial Cancer

Thank you

Trial Information

A Phase I Trial of Intravenous Paclitaxel, Intraperitoneal Carboplatin and Intraperitoneal Paclitaxel or Intravenous Docetaxel, Intraperitoneal Carboplatin and Intraperitoneal Paclitaxel or Intravenous Paclitaxel, Intraperitoneal Carboplatin, Intraperitoneal Paclitaxel and CTEP-Supplied Agent Bevacizumab (NSC 704865, IND 7921) in Patients With Previously Untreated Ovarian, Fallopian Tube or Primary Peritoneal Carcinoma


OBJECTIVES:

I. Determine the maximum tolerated dose (MTD) of intraperitoneal (IP) carboplatin when given
in combination with IV paclitaxel followed by IP paclitaxel in patients with stage III or IV
ovarian epithelial, fallopian tube, or primary peritoneal cavity carcinoma.

II. Determine the MTD of IP carboplatin and IV docetaxel when given in combination with IP
paclitaxel in these patients.

III. To determine the feasibility of the combination of IV paclitaxel, IP carboplatin and IV
bevacizumab on day one followed by IP paclitaxel on day eight (Part C Only).

IV. Determine the dose-limiting toxic effects and complications in patients treated with
these regimens.

V. Evaluate the neurotoxicity of this regimen at each cycle using the FACT/GOG-NTX4
assessment tool to determine dose reduction in these patients.

VI. Evaluate the techniques used for intraperitoneal catheter placement, surgical
procedures, and reporting of outcomes in these patients.

OUTLINE: This is a multicenter, dose-escalation study of intraperitoneal (IP) carboplatin.

Patients in the dose-escalation phase are not eligible to enter the feasibility phase.

DOSE-ESCALATION PHASE (PART A or PART B): Patients receive IP carboplatin on day 1, and
paclitaxel IV over 3 hour (part A) or docetaxel IV over 1 hour (Part B) on day 1, and IP
paclitaxel on day 8. Treatment repeats every 21 days for 6 courses in the absence of disease
progression or unacceptable toxicity.

FEASIBILITY PHASE (PART C): Patients receive IP carboplatin on day 1, paclitaxel IV on day
1, and IP paclitaxel on day 8 in course 1 as in part A dose-escalation phase. Beginning in
course 2 and all subsequent courses, patients receive IP carboplatin on day 1, IV paclitaxel
on day 1, and IP paclitaxel on day 8 as in the dose-escalation phase, and bevacizumab IV
over 30-90 minutes on day 1. Treatment repeats every 21 days for 6 courses in the absence of
disease progression or unacceptable toxicity.

Patients are followed every 3 months for 1 year.


Inclusion Criteria:



- Histologically confirmed fallopian tube, ovarian epithelial, or primary peritoneal
carcinoma

- Stage II-IV disease

- The following epithelial cell types are allowed:

- Carcinosarcoma

- Serous adenocarcinoma

- Endometrioid adenocarcinoma

- Mucinous adenocarcinoma

- Undifferentiated carcinoma

- Clear cell adenocarcinoma

- Mixed epithelial carcinoma

- Transitional cell carcinoma

- Malignant Brenner's tumor

- Adenocarcinoma not otherwise specified

- Must have undergone prior surgery for ovarian or peritoneal carcinoma within the past
12 weeks

- Optimal (≤ 1 cm residual disease) or suboptimal residual disease following
initial surgery

- Must have a procedure for determining diagnosis of ovarian/peritoneal carcinoma
with appropriate tissue for histologic evaluation

- Synchronous primary endometrial cancer or prior endometrial cancer allowed provided
the following criteria are met:

- Stage ≤ IB

- Less than 3 mm invasion without vascular or lymphatic invasion

- No poorly differentiated subtypes (e.g., grade 3, clear cell, or papillary
serous)

- No epithelial ovarian carcinoma of low malignant potential (borderline carcinomas)

- No CNS disease (e.g., seizures not controlled with standard medical therapy) or
metastasis

- GOG performance status 0-2

- Absolute neutrophil count ≥ 1,500/mm^3

- Platelet count ≥ 100,000/mm^3

- INR ≤ 1.5 (or an in-range INR, usually between 2 and 3, if a patient is on a stable
dose of therapeutic warfarin for management of venous thrombosis including pulmonary
thrombo-embolus) (applies to part C only)

- PTT < 1.2 times the upper limit of normal (applies to part C only)

- SGOT ≤ 2.5 times normal

- Alkaline phosphatase ≤ 2.5 times normal

- Bilirubin ≤ 1.5 times normal

- Creatinine ≤ 1.5 times normal

- No active bleeding

- Abnormal cardiac conduction (e.g., bundle branch block or heart block) allowed
provided disease has remained stable for the past 6 months

- No unstable angina or myocardial infarction within the past 6 months

- No neuropathy (sensory and motor) > CTCAE grade 1

- Not pregnant or nursing

- Fertile patients must use effective contraception during and for at least 6 months
after completion of study therapy

- No septicemia, severe infection, or acute hepatitis

- No other invasive malignancy within the past 5 years except non-melanoma skin cancer
or localized breast cancer

- No circumstance that would preclude study participation

- No history of allergic reaction to polysorbate 80 (e.g., etoposide or vitamin E)

- No known hypersensitivity to Chinese hamster ovary cell products or other recombinant
human or humanized antibodies (applies to part C only)

- No clinically significant proteinuria

- Must have urine protein-creatinine ratio (UPCR) < 1

- No serious, non-healing wound, ulcer, or bone fracture (applies to part C only)

- At least 3-6 months since prior abdominal fistula or gastrointestinal perforation and
fully recovered (part C only)

- No history of intra-abdominal abscess within the past 28 days (applies to part C
only)

- No active bleeding or pathologic conditions that carry high risk of bleeding, such as
known bleeding disorder, coagulopathy, or tumor involving major vessels (applies to
part C only)

- No history or evidence (upon physical examination) of CNS disease, including primary
brain tumor, seizures not controlled with standard medical therapy, or brain
metastases (applies to part C only)

- No history of cerebrovascular accident (CVA, stroke), transient ischemic attack (TIA)
or subarachnoid hemorrhage within six months of the first date of treatment on this
study (applies to part C only)

- No significant traumatic injury within 28 days (applies to part C only)

- No clinically significant cardiovascular disease, including any of the following
(applies to part C only):

- Uncontrolled hypertension, defined as systolic BP > 150 mm Hg or diastolic BP >
90 mm Hg

- Myocardial infarction or unstable angina < 6 months prior to registration

- New York Heart Association (NYHA) Grade II or greater congestive heart failure

- Serious cardiac arrhythmia requiring medication

- CTCAE Grade 2 or greater peripheral vascular disease (at least brief (< 24 hrs)
episodes of ischemia managed non-surgically and without permanent deficit)

- History of CVA within the past six months

- No clinical symptoms or signs of gastrointestinal obstruction and who require
parenteral hydration and/or nutrition (applies to part C only)

- No prior therapy with any anti-VEGF drug, including bevacizumab (applies to part C
only)

- No prior chemotherapy

- Prior adjuvant chemotherapy for localized breast cancer allowed provided the
therapy was completed at least 3 years before registration to study and the
patient remains free of recurrent or metastatic disease

- No prior radiotherapy

- No prior cancer therapy that would contraindicate study treatment

- No anticipation of invasive procedures, including any of the following (applies to
part C only):

- Major surgical procedure or open biopsy within 28 days prior to the first date
of bevacizumab therapy (cycle 2)

- Major surgical procedure anticipated during the course of the study

- Core biopsy within 7 days prior to the first date of bevacizumab therapy

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Maximum tolerated dose (MTD) of IV paclitaxel with IP carboplatin followed by IP paclitaxel, determined according to dose-limiting toxicities (DLTs) graded using Common Terminology Criteria for Adverse Events version 3.0 (CTCAE v3.0)

Outcome Time Frame:

3 weeks

Safety Issue:

Yes

Principal Investigator

Joan Walker

Investigator Role:

Principal Investigator

Investigator Affiliation:

Gynecologic Oncology Group

Authority:

United States: Food and Drug Administration

Study ID:

NCI-2009-00619

NCT ID:

NCT00085358

Start Date:

May 2004

Completion Date:

Related Keywords:

  • Brenner Tumor
  • Fallopian Tube Cancer
  • Ovarian Carcinosarcoma
  • Ovarian Clear Cell Cystadenocarcinoma
  • Ovarian Endometrioid Adenocarcinoma
  • Ovarian Mixed Epithelial Carcinoma
  • Ovarian Mucinous Cystadenocarcinoma
  • Ovarian Serous Cystadenocarcinoma
  • Ovarian Undifferentiated Adenocarcinoma
  • Primary Peritoneal Cavity Cancer
  • Stage II Ovarian Epithelial Cancer
  • Stage III Ovarian Epithelial Cancer
  • Stage IV Ovarian Epithelial Cancer
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous
  • Brenner Tumor
  • Carcinoma
  • Carcinosarcoma
  • Mixed Tumor, Mullerian
  • Cystadenocarcinoma
  • Peritoneal Neoplasms
  • Fallopian Tube Neoplasms
  • Carcinoma, Endometrioid
  • Cystadenocarcinoma, Mucinous
  • Cystadenocarcinoma, Serous
  • Neoplasms, Glandular and Epithelial
  • Ovarian Neoplasms

Name

Location

Johns Hopkins UniversityBaltimore, Maryland  21205
University of Iowa Hospitals and ClinicsIowa City, Iowa  52242
Washington University School of MedicineSaint Louis, Missouri  63110
University of Oklahoma Health Sciences CenterOklahoma City, Oklahoma  73104
Greater Baltimore Medical CenterBaltimore, Maryland  21204
Case Western Reserve UniversityCleveland, Ohio  44106
University of Chicago Comprehensive Cancer CenterChicago, Illinois  60637-1470
Cooper Hospital University Medical CenterCamden, New Jersey  08103
University of California Medical Center At Irvine-Orange CampusOrange, California  92868
Cancer Care Associates-YaleTulsa, Oklahoma  74136-1929
Cancer Care Associates-MidtownTulsa, Oklahoma  74104
Women and Infants HospitalProvidence, Rhode Island  02905
Colorado Gynecologic Oncology GroupAurora, Colorado  80010
Lake University Ireland Cancer CenterMentor, Ohio  44060
Gynecologic Oncology GroupPhiladelphia, Pennsylvania  19103
Cleveland Clinic Cancer Center/Fairview HospitalCleveland, Ohio  44111