Know Cancer

or
forgot password

Randomized Phase II AGO-Study Comparing Combined Liposomal Doxorubicin (Myocet) and Gemcitabine (Gemzar) With Liposomal Doxorubicin (Myocet) Monotherapy in Platinum-Refractory and Platinum-Resistant Epithelial Cancer of the Ovary, Fallopian Tube and the Peritoneum


Phase 2
18 Years
N/A
Open (Enrolling)
Female
Fallopian Tube Cancer, Ovarian Cancer, Primary Peritoneal Cavity Cancer

Thank you

Trial Information

Randomized Phase II AGO-Study Comparing Combined Liposomal Doxorubicin (Myocet) and Gemcitabine (Gemzar) With Liposomal Doxorubicin (Myocet) Monotherapy in Platinum-Refractory and Platinum-Resistant Epithelial Cancer of the Ovary, Fallopian Tube and the Peritoneum


OBJECTIVES:

Primary

- To assess the response rate to liposome-encapsulated doxorubicin citrate and
gemcitabine hydrochloride versus liposome-encapsulated doxorubicin citrate alone in
patients with platinum-refractory or platinum-resistant ovarian epithelial, fallopian
tube, or primary peritoneal cavity cancer.

Secondary

- To assess the quality of life of patients treated with these regimens.

- To determine the progression-free and overall survival of patients treated with these
regimens.

- To determine the toxicity of these regimens.

OUTLINE: This is a multicenter study. Patients are stratified according to disease
(platinum-refractory disease vs platinum-resistant disease. Patients are randomized to 1 of
2 treatment arms.

- Arm I: Patients receive liposome-encapsulated doxorubicin citrate IV over 60 minutes on
day 1 and gemcitabine hydrochloride IV over 30 minutes on days 1 and 8. Treatment
repeats every 3 weeks for 6 courses in the absence of disease progression or
unacceptable toxicity.

- Arm II: Patients receive liposome-encapsulated doxorubicin citrate IV over 60 minutes
on day 1. Treatment repeats every 3 weeks for 6 courses in the absence of disease
progression or unacceptable toxicity.

Patients who experience clinical benefit after completion of 6 courses of chemotherapy may
continue therapy at the discretion of the investigator.

Patients complete quality-of-life questionnaires (EORTC-QLQ30 and QLQ-OV28) at baseline,
during, and after completion of study therapy. After completion of study treatment, patients
are followed up every 3 months for up to 1 year.

Inclusion Criteria


DISEASE CHARACTERISTICS:

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

- Progression or recurrence during first-line platinum-based chemotherapy
(platinum-refractory disease) OR progression or recurrence during the first 6 months
following the end of the last platinum-containing chemotherapy (platinum-resistant
disease)

- Meets ≥ 1 of the following criteria:

- Measurable metastatic disease on CT or MRI scan, ultrasound, or chest x-ray

- Evaluable disease on CT/MRI scan (e.g., ascites or pleural effusion) or chest
x-ray (e.g., pleural effusion)

- Tumor marker progression (CA-125) according to Rustin criteria, meeting 1 of the
following criteria:

- CA-125 > 2 times upper limit of normal (UNL)

- CA-125 > 2 times nadir value on two occasions

- No ovarian carcinosarcoma (malignant mixed Müllerian tumor) or pure sarcoma

PATIENT CHARACTERISTICS:

- Karnofsky performance status 70-100%

- Life expectancy ≥ 3 months

- Platelet count ≥ 100,000/mm³

- Hemoglobin ≥ 10 g/dL

- Neutrophil count ≥ 1.5 x 10³/mm³

- Serum creatinine < 1.5 times ULN

- Bilirubin < 1.5 times ULN (< 2.5 times ULN if liver metastases are present)

- AST/ALT < 2.5 times ULN (unless caused by parenchymal liver metastases)

- No childbearing capacity

- LVEF ≥ 50% by ECHO or MUGA scan

- No significant comorbidity (e.g., uncontrolled infection, clinical signs of cardiac
insufficiency, history of myocardial infarction, or cardiac rhythmic disorders [NYHA
class III-IV disease])

- No known hypersensitivity to study drugs

- No active secondary malignant tumor within the past 5 years (e.g., metastases from
primary breast cancer)

- No condition (medical, social, or psychological), that would prevent adequate
follow-up

PRIOR CONCURRENT THERAPY:

- No prior chemotherapy with pegylated liposomal doxorubicin hydrochloride, other
anthracyclines, or gemcitabine hydrochloride

- No other concurrent tumor-specific therapy for ovarian cancer

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Primary Purpose: Treatment

Outcome Measure:

Remission rates (complete response and partial response)

Safety Issue:

No

Principal Investigator

Alain Zeimet

Investigator Role:

Principal Investigator

Investigator Affiliation:

Medical University Innsbruck

Authority:

Unspecified

Study ID:

CDR0000669716

NCT ID:

NCT01100372

Start Date:

July 2009

Completion Date:

Related Keywords:

  • Fallopian Tube Cancer
  • Ovarian Cancer
  • Primary Peritoneal Cavity Cancer
  • recurrent ovarian epithelial cancer
  • recurrent fallopian tube cancer
  • recurrent primary peritoneal cavity cancer
  • Ovarian Neoplasms
  • Peritoneal Neoplasms
  • Fallopian Tube Neoplasms
  • Neoplasms, Glandular and Epithelial

Name

Location