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A Phase I Study of IV Doxorubicin Plus Intraperitoneal (IP) Paclitaxel and IV or IP Cisplatin in Endometrial Cancer Patients at High Risk for Peritoneal Failure


Phase 1
N/A
N/A
Open (Enrolling)
Female
Endometrial Cancer, Ovarian Cancer

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Trial Information

A Phase I Study of IV Doxorubicin Plus Intraperitoneal (IP) Paclitaxel and IV or IP Cisplatin in Endometrial Cancer Patients at High Risk for Peritoneal Failure


OBJECTIVES:

- To determine the maximum tolerated dose of intraperitoneal (IP) paclitaxel when given
concurrently with fixed dose IV doxorubicin hydrochloride and IV cisplatin in patients
with endometrial cancer at high-risk for peritoneal failure.

- To determine the maximum tolerated dose of IP paclitaxel when given concurrently with
fixed dose IV doxorubicin hydrochloride and IP cisplatin.

- To determine the feasibility of an IV/IP based doxorubicin hydrochloride, paclitaxel,
and cisplatin chemotherapy regimen in patients with advanced endometrial cancer.

OUTLINE: This is a multicenter, dose-escalation study of paclitaxel.

Patients receive doxorubicin hydrochloride IV over 50 minutes followed by cisplatin IV over
1 hour on day 1, paclitaxel IV over 3 hours on day 2, and filgrastim (G-CSF) IV on days 3-12
or pegfilgrastim subcutaneously on day 3. Treatment repeats every 21 days for up to 2
courses in the absence of disease progression or unacceptable toxicity.

Patients then receive doxorubicin hydrochloride IV, cisplatin IV or intraperitoneally (IP),
and paclitaxel IP on day 1 or day 8. Treatment repeats every 21 days for up to 4 courses in
the absence of disease progression or unacceptable toxicity.

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

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically confirmed endometrial cancer meeting the following criteria:

- Any of the following subtypes are allowed:

- Endometrioid

- Serous

- Clear cell

- Squamous/adenosquamous

- Undifferentiated

- Mixed histology

- All of the following disease stages are allowed:

- Stage IIIA disease

- Stage IIIC disease with positive cytologic washings/ascites, adnexal
spread, or serosal involvement

- Stage IV disease (by virtue of intraperitoneal disease spread)

- Prior total abdominal hysterectomy, bilateral salpingo-oophorectomy by either
laparotomy or laparoscopic assisted techniques

- Intraperitoneal and bulky nodal disease debulked to ≤ 2 cm gross maximal
residual margins

- No metastatic disease involving lung or liver parenchyma, bone, or inguinal or
scalene lymph nodes

PATIENT CHARACTERISTICS:

- GOG performance status 0-2

- ANC ≥ 1,500/mm³

- Platelet count ≥ 100,000/mm³

- Hemoglobin ≥ 10 g/dL

- Creatinine ≤ 2 mg/dL OR creatinine clearance > 50 mL/min

- Bilirubin ≤ 1.5 times upper limit of normal (ULN)

- AST ≤ 2.5 times ULN

- Alkaline phosphatase ≤ 2.5 times ULN

- Neuropathy (sensory and motor) ≤ grade 1

- Ejection fraction normal

- No concurrent medical illness (e.g., serious uncontrolled infection, uncontrolled
angina, or serious peripheral neuropathy), which in the opinion of the treating
physician, makes the protocol treatments hazardous to the patient

- No third degree or complete heart block (unless a pacemaker is in place)

- Patients with other cardiac conduction abnormalities may be placed on study at
the discretion of the investigator

- No history of other invasive malignancies, except nonmelanoma skin cancer or evidence
of other malignancy present within the past 5 years

PRIOR CONCURRENT THERAPY:

- See Disease Characteristics

- No more than 8 weeks since prior surgery

- Patients who are on medications which alter cardiac conduction (i.e., digitalis, beta
blockers, or calcium channel blockers) may be placed on study at the discretion of
the investigator

- No prior cancer treatment that contraindicates this protocol therapy

- No prior radiotherapy or chemotherapy for endometrial cancer at high risk for
peritoneal failure

- No concurrent prophylactic filgrastim/pegfilgrastim during intraperitoneal portion of
treatment (i.e., courses 3-6).

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Outcome Measure:

Assessment of acute toxicity during courses 3-4 to identify maximum tolerated dose

Safety Issue:

Yes

Principal Investigator

D. Scott McMeekin, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Oklahoma University Cancer Institute

Authority:

Unspecified

Study ID:

CDR0000580419

NCT ID:

NCT00575952

Start Date:

January 2008

Completion Date:

Related Keywords:

  • Endometrial Cancer
  • Ovarian Cancer
  • endometrial adenosquamous cell carcinoma
  • endometrial clear cell carcinoma
  • ovarian endometrioid adenocarcinoma
  • ovarian endometrioid tumor with proliferating activity
  • stage III endometrial carcinoma
  • stage IV endometrial carcinoma
  • recurrent endometrial carcinoma
  • Endometrial Neoplasms
  • Sarcoma, Endometrial Stromal
  • Ovarian Neoplasms
  • Adenoma

Name

Location

Case Comprehensive Cancer CenterCleveland, Ohio  44106-5065
Holden Comprehensive Cancer Center at University of IowaIowa City, Iowa  52242-1002
Siteman Cancer Center at Barnes-Jewish Hospital - Saint LouisSt. Louis, Missouri  63110
Oklahoma University Cancer InstituteOklahoma City, Oklahoma  73104
Cancer Institute of New Jersey at Cooper - VoorheesVoorhees, New Jersey  08043