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Phase I/II Trial, Dose Finding Combination Chemotherapy With PegLiposomal Doxorubicin (PLD) And Carboplatin In Patients With Gynecologic Tumors

Phase 1/Phase 2
18 Years
Not Enrolling
Cervical Cancer, Endometrial Cancer, Fallopian Tube Cancer, Ovarian Cancer, Sarcoma

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Trial Information

Phase I/II Trial, Dose Finding Combination Chemotherapy With PegLiposomal Doxorubicin (PLD) And Carboplatin In Patients With Gynecologic Tumors


- Determine the maximum tolerated dose of doxorubicin HCl liposome when administered with
carboplatin in patients with gynecological tumors.

- Determine the dose-limiting toxicity of this regimen in these patients.

- Determine the kind, frequency, severity, and duration of adverse events in patients
treated with this regimen.

OUTLINE: This is a multicenter, dose-escalation study of doxorubicin HCl liposome.

Patients receive doxorubicin HCl liposome IV over 60 minutes followed by carboplatin IV over
30 minutes on day 1. Treatment repeats every 28 days for 6 courses.

Cohorts of 3-6 patients receive escalating doses of doxorubicin HCl liposome until the
maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at
which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Once the MTD is
determined, additional patients are accrued and treated at the MTD as above.

Patients are followed at 4-6 weeks and then every 3 months thereafter.

PROJECTED ACCRUAL: A total of 12-24 patients will be accrued for this study within 1 year.

Inclusion Criteria


- Histologically or cytologically confirmed fallopian tube cancer, Muellerian mixed
tumor, endometrial cancer, uterine sarcoma, ovarian cancer with sarcoma parts, or
cervical cancer

- No ovarian epithelial cancer



- 18 and over

Performance status:

- ECOG 0-2 OR

- Karnofsky 70-100%

Life expectancy:

- At least 3 months


- Absolute neutrophil count at least 1,500/mm3

- Platelet count at least 100,000/mm3

- Hemoglobin greater than 10.0 g/dL


- Bilirubin no greater than 1.25 times upper limit of normal


- Glomerular filtration rate at least 60 mL/min


- No atrial or ventricular arrhythmias

- No congestive heart failure even if stabilized on medication

- No New York Heart Association class III or IV heart disease

- No myocardial infarction within the past 6 months


- No pre-existing sensory or motor neuropathy grade 2 or greater

- No active infection

- No other serious medical condition that would preclude study

- Not pregnant

- Negative pregnancy test

- Fertile patients must use effective contraception


Biologic therapy:

- At least 4 weeks since prior immunotherapy


- No more than 1 prior chemotherapy regimen for the malignancy

- No other concurrent chemotherapy

Endocrine therapy:

- Prior hormonal therapy within the past 10 days allowed

- No concurrent hormonal therapy


- At least 6 weeks since prior radiotherapy to no more than 25% of bone marrow


- Not specified


- At least 30 days since prior experimental agents

- No other concurrent therapies that would preclude study

- No concurrent participation in another study

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:


Outcome Time Frame:

DLT during first 3 cycles

Safety Issue:


Principal Investigator

Andreas du Bois, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

Dr. Horst-Schmidt-Kliniken


Germany: Federal Institute for Drugs and Medical Devices

Study ID:




Start Date:

August 2001

Completion Date:

Related Keywords:

  • Cervical Cancer
  • Endometrial Cancer
  • Fallopian Tube Cancer
  • Ovarian Cancer
  • Sarcoma
  • stage III cervical cancer
  • recurrent cervical cancer
  • stage IB cervical cancer
  • stage IIB cervical cancer
  • stage IVB cervical cancer
  • stage IA cervical cancer
  • stage IIA cervical cancer
  • stage IVA cervical cancer
  • stage I endometrial carcinoma
  • stage II endometrial carcinoma
  • stage III endometrial carcinoma
  • stage IV endometrial carcinoma
  • recurrent endometrial carcinoma
  • fallopian tube cancer
  • stage I uterine sarcoma
  • stage II uterine sarcoma
  • stage III uterine sarcoma
  • stage IV uterine sarcoma
  • recurrent uterine sarcoma
  • ovarian sarcoma
  • ovarian carcinosarcoma
  • Endometrial Neoplasms
  • Uterine Cervical Neoplasms
  • Ovarian Neoplasms
  • Fallopian Tube Neoplasms
  • Adenoma
  • Sarcoma