Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

All Conditions

Rare Diseases

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Carcinoma

Endocrine Gland Neoplasms

Ovarian Diseases

Adnexal Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Genital Neoplasms, Female

Urogenital Neoplasms

Endocrine System Diseases

Gonadal Disorders

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Ovarian Cancer

Ovarian Epithelial Cancer

All Drugs and Chemicals

Antineoplastic Agents

Hypoglycemic Agents

Pharmaceutical Solutions

Antibodies

Antibodies, Monoclonal

Paclitaxel

Carboplatin

Insulin

Insulin, Globin Zinc

Albumin-Bound Paclitaxel

Immunoglobulins

Mitogens

Immunologic Factors

Placebo plus paclitaxel/carboplatin chemotherapy administered on Day 1 of each 21-day cycle for 6 cycles - then 6 additional cycles of placebo administered on Day 1 of each 21-day cycle.

AMG 479 plus paclitaxel/carboplatin chemotherapy administered on Day 1 of each 21-day cycle for 6 cycles - then 6 additional cycles of AMG 479 single agent administered on Day 1 of each 21-day cycle.

Solution for infusion - 18 mg/kg on day 1 of each 21-day cycle

AMG 479

Matching placebo administered Day 1 of each 21 day cycle.

AMG 479 Placebo

Gottfried E Konecny, MD

This study will determine the value of adding AMG 479 (fully human monoclonal antibody against IGF-1R) to paclitaxel and carboplatin first line chemotherapy in patients with optimally debulked (\<1 cm) FIGO stage III and IV (positive pleural cytology only) ovarian epithelial (including fallopian tube and primary peritoneal) carcinoma.

Study of Adding AMG 479 to First Line Chemotherapy in Patients With Optimally Debulked Epithelial Ovarian Cancer

A Randomized, Double-blind, Placebo Controlled, Multi-center, Phase II Study of Adding AMG 479, a Fully Human Monoclonal Antibody Against Insulin-like Growth Factor Type 1 Receptor (IGF-1R) to First Line Chemotherapy in Patients With Optimally Debulked ( < 1 cm ) Epithelial Ovarian Cancer

A patient may have been declared to have progressive disease on the basis of radiological measuremt of tumor lesions assessmt or CA125 evaluation (tumor measuremts taking precedence).Radiological progression was defined as per the RECIST guidelines (Therasse et al, JNCI2000) as at least 20% increase in the sum of the longest diameters of target lesions(ref the smallest sum of the longest diam recorded since the treatmt started or since the appearance of at least 1 new lesion).Serum CA125 progression was defined, according to the 2005 GCIG def: pts with:

* Elevated CA125 pretreatmt and normalization of CA125 has to show evidence of CA125≥ 2 times the upper normal limit on 2 occasions at least 1 wk apart OR
* Elevated CA125 pretreatmt which never normalized must show evidence of CA125≥ 2 times the nadir value on 2 occasions at least 1 wk apart OR
* CA125 in the normal range pretreatmt had to show evidence of CA125 ≥ 2 times the upper normal limit on 2 occasions at least 1 wk apart

Interval between the date from randomization to death from any cause whichever came first.

Translational Research in Oncology

For participant flow module it is based on Intent To Treat so the patients are counted according to their "randomization group".For "participants at risk" the patients are grouped by the "actual treatment" 4 patients were allocated with incorrect treatment and received AMG479 instead of Placebo.The total number of patients treated remains the same.

Placebo plus paclitaxel/carboplatin chemotherapy administered on Day 1 of each 21-day cycle for 6 cycles - then 6 additional cycles of placebo administered on Day 1 of each 21-day cycle.

AMG 479 Placebo: Matching placebo administered Day 1 of each 21 day cycle.

A Control

AMG 479 plus paclitaxel/carboplatin chemotherapy administered on Day 1 of each 21-day cycle for 6 cycles - then 6 additional cycles of AMG 479 single agent administered on Day 1 of each 21-day cycle.

AMG 479: Solution for infusion - 18 mg/kg on day 1 of each 21-day cycle

B Experimental

Total

Age, Categorical

Age, Continuous

Sex: Female, Male

United States

United Kingdom

Canada

France

Israel

Spain

Germany

Region of Enrollment

PS 0 (fully active)

PS 1 (restricted in physically strenuous activity)

PS2(ambulatory and capable of all selfcare)

Missing

6-point (0 to 5) ordinal scale to assess how the disease affects the daily living abilities of the patients and determine appropriate treatment and prognosis

Eastern Cooperative Oncology Group Performance Status (ECOG PS)

Time from Surgery to first treatment dose

Time from diagnosis to randomization

Primary peritoneal

Fallopian tube

Ovarian

Ovarian + Primary peritoneal

Ovarian + Fallopian tube

Origin of tumor

IIIA

IIIB

IIIC

5-point ordinal scale to assess the extent of the disease (0-\>IV). Roman numeral staging from the less to the most advanced cancer. Individual stage (I to III) is broken down in substage: IA, IB, IC,...

Stage at first diagnosis (International Federation of Gynecology and Obstetrics (FIGO))

papillary serous

mucinous

endometroid

clear cell

mixed

other

Histopathologic type

G1 (well differentiated)

G2 (moderately differentiated)

G3 (poorly differentiated)

Not done

Histologic Grade

1 therapy

2 therapies

Prior anti-tumor treatment characteristics

Number of prior therapies

with elevated CA 125

with CA 125 in the normal range

missing

CA 125 status

Matthieu Rupin

Progression Free Survival (PFS): Time From Randomization Until Date of Progression or Death.

Time To Progression (TTP): Interval From the Date of Randomization to the Date of Disease Progression

Overall Survival (OS)

Overall Study

Spots Global Cancer Trial Database for amg 479 placebo