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A Phase I Feasibility Trial IP Cisplatin and IV Paclitaxel on Day One Followed by IP Paclitaxel on Day 8 Every 21 Days as Front-Line Treatment of Ovarian, Fallopian Tube and Primary Peritoneal Carcinoma


Phase 1
N/A
N/A
Not Enrolling
Female
Chemotherapeutic Agent Toxicity, Endometrial Cancer, Fallopian Tube Cancer, Gastrointestinal Complications, Neurotoxicity, Ovarian Cancer, Primary Peritoneal Cavity Cancer

Thank you

Trial Information

A Phase I Feasibility Trial IP Cisplatin and IV Paclitaxel on Day One Followed by IP Paclitaxel on Day 8 Every 21 Days as Front-Line Treatment of Ovarian, Fallopian Tube and Primary Peritoneal Carcinoma


OBJECTIVES:

Primary

- Determine the feasibility of intraperitoneal (IP) cisplatin and intravenous paclitaxel
followed by IP paclitaxel in patients with stage IIB, IIC, III, or IV ovarian
epithelial, fallopian tube, or primary peritoneal cavity cancer.

Secondary

- Assess the toxicity of this regimen in these patients.

- Determine the types of surgical and catheter complications that may occur after surgery
or during the course of treatment in these patients.

- Estimate the response rate in patients with measurable disease treated with this
regimen.

OUTLINE: This is a multicenter study.

Patients receive paclitaxel IV over 3 hours and cisplatin intraperitoneally (IP) on day 1
and paclitaxel IP on day 8. Treatment repeats every 21 days for up to 6 courses in the
absence of disease progression or unacceptable toxicity.

After completion of study therapy, patients are followed every 3 months for 1 year.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically confirmed ovarian epithelial, fallopian tube, or primary peritoneal
cavity cancer

- Stage IIB, IIC, III, or IV disease

- Optimal or suboptimal residual disease after debulking surgery within the past
12 weeks

- Appropriate tissue for histologic evaluation available

- 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 tumor

- Adenocarcinoma not otherwise specified

- Carcinosarcoma

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

- No synchronous primary endometrial cancer or a history of primary endometrial cancer
unless all of the following conditions are met:

- Stage ≤ IB disease

- 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 lesion

PATIENT CHARACTERISTICS:

- GOG performance status 0-2

- ANC ≥ 1,500/mm^3

- Platelet count ≥ 100,000/mm^3

- Serum creatinine ≤ 1.5 times upper limit of normal (ULN)

- Bilirubin ≤ 1.5 times ULN

- Alkaline phosphatase ≤ 2.5 times ULN

- SGOT ≤ 2.5 times ULN

- Audiograms required after study chemotherapy courses 3 and 6 for patients with
hearing loss, or who are experiencing tinnitus during study therapy

- Negative pregnancy test

- Not pregnant or nursing

- Fertile patients must use effective contraception

- None of the following:

- Septicemia

- Severe infection requiring parenteral antibiotics

- Malnutrition requiring parenteral hyperalimentation

- Acute hepatitis

- Any other major medical conditions expected to interfere with completion of
protocol therapy

- No active bleeding

- No circumstances that would prohibit completion of study therapy or required
follow-up

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

- No other invasive malignancies, except for nonmelanoma skin cancer or other specific
malignancies within the past 5 years, or whose previous cancer treatment
contraindicates this protocol therapy

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

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

PRIOR CONCURRENT THERAPY:

- See Disease Characteristics

- No prior chemotherapy

- No prior radiotherapy

- No prior hormonal therapy for the management of epithelial ovarian or primary
peritoneal cavity cancer

- No prior targeted therapy for the management of ovarian epithelial or primary
peritoneal cavity cancer including, but not limited to, the following:

- Vaccines

- Antibodies

- Tyrosine kinase inhibitors

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

The number of patients who have at least 1 dose-limiting toxicity or delay in therapy for more than 2 weeks during the first 4 courses of treatment

Safety Issue:

Yes

Principal Investigator

Don S. Dizon, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Women and Infants Hospital of Rhode Island

Authority:

United States: Federal Government

Study ID:

CDR0000629746

NCT ID:

NCT00814086

Start Date:

February 2009

Completion Date:

Related Keywords:

  • Chemotherapeutic Agent Toxicity
  • Endometrial Cancer
  • Fallopian Tube Cancer
  • Gastrointestinal Complications
  • Neurotoxicity
  • Ovarian Cancer
  • Primary Peritoneal Cavity Cancer
  • neurotoxicity
  • chemotherapeutic agent toxicity
  • gastrointestinal complications
  • stage II ovarian epithelial cancer
  • stage III ovarian epithelial cancer
  • stage IV ovarian epithelial cancer
  • fallopian tube cancer
  • primary peritoneal cavity cancer
  • ovarian serous cystadenocarcinoma
  • endometrial adenocarcinoma
  • ovarian mucinous cystadenocarcinoma
  • ovarian undifferentiated adenocarcinoma
  • ovarian clear cell cystadenocarcinoma
  • ovarian mixed epithelial carcinoma
  • Brenner tumor
  • Endometrial Neoplasms
  • Ovarian Neoplasms
  • Peritoneal Neoplasms
  • Fallopian Tube Neoplasms
  • Adenoma
  • Neurotoxicity Syndromes
  • Neoplasms, Glandular and Epithelial

Name

Location

University of Chicago Cancer Research CenterChicago, Illinois  60637
Case Comprehensive Cancer CenterCleveland, Ohio  44106-5065
Abramson Cancer Center of the University of PennsylvaniaPhiladelphia, Pennsylvania  19104-4283
Holden Comprehensive Cancer Center at University of IowaIowa City, Iowa  52242-1002
Women and Infants Hospital of Rhode IslandProvidence, Rhode Island  02905
Oklahoma University Cancer InstituteOklahoma City, Oklahoma  73104
University of Virginia Cancer CenterCharlottesville, Virginia  22908
Cancer Institute of New Jersey at Cooper - VoorheesVoorhees, New Jersey  08043
Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer CenterColumbus, Ohio  43210-1240