Intergroup trial: Randomized Phase II Clinical Trial of Pegylated Liposomal Doxorubicin plus Carboplatin versus Gemcitabine plus Carboplatin in Platinum-Sensitive Patients with Recurrent Epithelial Ovarian Carcinoma, Primary Carcinoma of FallopianTube, and Peritoneal Carcinoma after Failure of Initial Platinum-based Chemotherapy

Intergroup trial: Randomized Phase II Clinical Trial of Pegylated Liposomal Doxorubicin plus Carboplatin versus Gemcitabine plus Carboplatin in Platinum-Sensitive Patients with Recurrent Epithelial Ovarian Carcinoma, Primary Carcinoma of FallopianTube, and Peritoneal Carcinoma after Failure of Initial Platinum-based Chemotherapy - iPLAS trial/GOTIC-003

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000005487

Enrollment

100

Registered

2011-04-22

Start date

2011-04-23

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Platinum-Sensitive Patients with Recurrent Epithelial Ovarian Carcinoma, Primary Carcinoma of FallopianTube, and Peritoneal Carcinoma

Interventions

Liposomal Doxorubicin(PLD)(30mg/m2) day1 + Carboplatin(AUC5) day1 q28days 6cycles Gemcitabine(GEM)(1000mg/m2) day1and 8 + Carboplatin(AUC4) day1 q21days 6cycles

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: 1)Histologically proven epithelial ovarian carcinoma, primally carcinoma of fallopian tube, or peritoneal carcinoma 2)Patients with platinum-sensitive recurrent ovarian cancer at least 6 months after completion of first-line, platinum-based therapy 3)Patients have at least one measurable or nonmeasurable disease. 4)Patients at least 20-years-old 5)Patients at an ECOG Performance Status of 0 to 2 6)Patients with adequate organ function 7)Patients with estimated life expevtancy of 4 months or longer 8)Patients obtained written informed consent

Exclusion criteria

Exclusion criteria: 1)Patients with fever of over 38.0 degrees C 2)Patients with active infection 3)Patients with serious complications 4)Patients with a second primary malignancy (except in situ carcinoma of the cervix or adequately treated basal cell carcinoma of the skin) 5)Patients with prior radiation therapy 6)Patients with pleural effusion,ascites or pericardial effusion which requires persistent drainage 7)Patients with prior treatment of Anthracycline or Gemcitabine Hydrochloride 8)Patients with clinical symptom of brain metastasis requiring medication 9)Patients with hepatic damage (hepatitis,hepatic cirrhosis), history or evidence upon alcoholism 10)Patients with positive HBsAg. 11)Patients with a history of hypersensitivity to Doxorubicin 12)Patients who are pregnant or nursing or of child bearing potential 13)Patients judged inappropriate for this study by the physicians

Design outcomes

Primary

Measure	Time frame
Progression-free survival	—

Secondary

Measure	Time frame
Overall response rate Overall survival Adverse event Tolerability	—

Countries

Japan

Contacts

Public ContactYuji Takei,M.D.,Ph.D/Izumi Kohara,RN,Ph.D,CCRP.

iPLAS Trial Office Jichi Medical University, Department of Obstetrics and Gynecology

fujiwara@jichi.ac.jp0285-58-7376

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026