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Randomized Phase III Trial Of Doxorubicin/Cisplatin/Paclitaxel And G-CSF Versus Carboplatin/Paclitaxel In Patients With Stage III & IV Or Recurrent Endometrial Cancer


Phase 3
18 Years
N/A
Open (Enrolling)
Female
Endometrial Cancer

Thank you

Trial Information

Randomized Phase III Trial Of Doxorubicin/Cisplatin/Paclitaxel And G-CSF Versus Carboplatin/Paclitaxel In Patients With Stage III & IV Or Recurrent Endometrial Cancer

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically confirmed endometrial carcinoma

-FIGO stage III or IV or recurrent disease

- Must know estrogen and progesterone status of the primary tumor

- Poor potential for curative treatment by radiotherapy and/or surgery

- At least 1 unidimensionally measurable lesion (for patients with stage III disease
only)

- At least 20 mm by conventional techniques (e.g., palpation, plain x-ray, CT
scan, or MRI) OR at least 10 mm by spiral CT scan

- Disease in a previously irradiated field acceptable as the only site of
measurable disease only if there has been clear progression since completion of
radiotherapy

PATIENT CHARACTERISTICS:

AGE

- 18 and over PERFORMANCE STATUS

- GOG 0-2 LIFE EXPECTANCY

- Not specified HEMATOPOIETIC

- Absolute neutrophil count at least 1,500/mm^3

- Platelet count at least 100,000/mm^3 HEPATIC

- Bilirubin normal

- ALT no greater than 3 times upper limit of normal RENAL

- Creatinine no greater than 1.6 mg/dL CARDIOVASCULAR

- LVEF at least 50%

- Cardiac conduction abnormalities or dysfunction allowed at the investigator's
discretion

- No third-degree or complete heart block without a pacemaker

- No uncontrolled angina

- No myocardial infarction within the past 6 months

- No New York Heart Association class II -IV heart failure

- No symptoms of congestive heart failure OTHER

- Not pregnant or nursing

- Fertile patients must use effective non-hormonal contraception during and for at
least 2 months after study participation

- No other invasive malignancy within the past 5 years except patients who have
nonmelanoma skin cancer or have received prior chemotherapy for that malignancy

- No serious uncontrolled infection

- No serious peripheral neuropathy

- No other concurrent medical illness that would preclude study therapy

- No circumstances that would preclude study completion or follow-up

- No sensitivity to Escherichia coli-derived drug preparations

- No uterine carcinosarcoma or other non-epithelial uterine malignancy

PRIOR CONCURRENT THERAPY:

BIOLOGIC THERAPY

- Prior biologic therapy allowed

- No concurrent biologic therapy CHEMOTHERAPY

- No prior cytotoxic chemotherapy (including radiotherapy sensitization) for this or
any other malignancy ENDOCRINE THERAPY

- Prior hormonal therapy allowed

- No concurrent hormonal therapy RADIOTHERAPY

- See Disease Characteristics

- At least 4 weeks since prior radiotherapy to the whole pelvis or over 50% of the
spine

- No concurrent radiotherapy SURGERY

- Not specified OTHER

- Concurrent medications that alter cardiac conduction (e.g., digitalis, beta blockers,
or calcium channel blockers) are allowed at the investigator's discretion

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Duration of overall survival

Outcome Time Frame:

Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.

Safety Issue:

No

Principal Investigator

David S. Miller, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Simmons Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

0120040379

NCT ID:

NCT00698620

Start Date:

August 2003

Completion Date:

Related Keywords:

  • Endometrial Cancer
  • Endometrial Neoplasms
  • Sarcoma, Endometrial Stromal
  • Adenoma

Name

Location

University of Medicine and Dentistry of New JerseyNewark, New Jersey  07103-2425