View Clinical Trial (Medical Research Study)
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
| City: |
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Saint Louis |
| State: |
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Missouri |
| Zip Code: |
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63110 |
| Conditions: |
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Endometrial Cancer - Ovarian Cancer |
| Purpose: |
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RATIONALE: Drugs used in chemotherapy, such as paclitaxel, doxorubicin, and cisplatin, work
in different ways to stop the growth of tumor cells, either by killing the cells or by
stopping them from dividing. Giving more than one drug (combination chemotherapy) and giving
them in different ways may kill more tumor cells.
PURPOSE: This phase I trial is studying the side effects and best dose of intraperitoneal
paclitaxel when given together with doxorubicin and cisplatin in treating patients with
endometrial cancer.
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| Study Summary: |
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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.
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| Criteria: |
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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).
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| NCT ID: |
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NCT00575952 |
| Primary Contact: |
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Study Chair
D. Scott McMeekin, MD
Oklahoma University Cancer Institute
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| Backup Contact: |
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N/A |
| Location Contact: |
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Saint Louis, Missouri 63110
United States
David G. Mutch, MD
Phone: 314-362-3181
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 18, 2013 |
| Modifications to this listing: |
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