Clinical trial · Interventional
Carboplatin/Paclitaxel +/-Gemcitabine in Treating Patients With Ovarian Epithelial or Fallopian Tube Cancer
A Multi-National Randomized Phase-III GCIG Intergroup-Study Comparing 1st-line Chemotherapy With Gemcitabine/Paclitaxel/Carboplatin vs Paclitaxel/Carboplatin In Previously Untreated Patients With Epithelial Ovarian Cancer FIGO Stages I-IV
NCT00052468CI-TRIAL-00014936AGO-OVAR9completedPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. It is not yet known whether carboplatin and paclitaxel combined with gemcitabine is more effective than carboplatin and paclitaxel alone in treating ovarian epithelial or fallopian tube cancer. PURPOSE: This randomized phase III trial is studying carboplatin and paclitaxel combined with gemcitabine to see how well it works compared to paclitaxel and carboplatin alone in treating patients who have undergone surgery for ovarian epithelial or fallopian tube cancer.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Fallopian Tube Cancer | Malignant Fallopian Tube Neoplasm | ALIAS | 0.90 |
| Ovarian Cancer | Malignant Ovarian Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| TC | Drug | — | UNRESOLVED |
| TCG | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- TCG
- description
- Paclitaxel 175 mg/m2 day 1, Carboplatin AUC 5 day 1, Gemcitabine 800 mg/m2 day 1 + 8, q 21 days / 6 - 10 courses
- interventionNames
- Drug: TCG
- type
- ACTIVE_COMPARATOR
- label
- TC
- description
- Paclitaxel 175 mg/m2 day 1, Carboplatin AUC 5 day 1, q 21 days / 6 - 10 courses
- interventionNames
- Drug: TC
Primary outcomes (1)
- measure
- Overall Survival
- timeFrame
- Whole Study Period
- description
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Histologically confirmed diagnosis of one of the following:
* Ovarian epithelial cancer
* FIGO stage IA/B G3, IC-IV
* Fallopian tube cancer
* Extra-ovarian papillary serous tumor
* The following are ineligible:
* Low malignant-potential ovarian tumors (borderline tumors)
* Non-epithelial ovarian tumors
* Mixed Mullerian tumors
* Must have had definitive surgery within the past 6 weeks
* No symptomatic brain metastases
PATIENT CHARACTERISTICS:
Age
* 18 and over
Performance status
* ECOG 0-2
Life expectancy
* At least 6 months
Hematopoietic
* WBC at least 3,000/mm\^3 OR
* Absolute neutrophil count at least 1,500/mm\^3
* Platelet count at least 100,000/mm\^3
* Hemoglobin greater than 10 mg/dL
Hepatic
* Bilirubin no greater than 2 times upper limit of normal
Renal
* Glomerular filtration rate at least 50 mL/min
Cardiovascular
* No congestive heart failure
* No myocardial infarction within the past 6 months
* No New York Heart Association class III or IV heart disease
* No prior atrial or ventricular arrhythmias
Other
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No prior seizures or central nervous system disorder
* No prior severe hypersensitivity reaction to products containing Cremophor EL (e.g., cyclosporine or vitamin K)
* No known hypersensitivity to compounds chemically related to carboplatin, gemcitabine, or paclitaxel
* No preexisting motor or sensory neuropathy greater than grade 1
* No other malignancy within the past 5 years except:
* Malignancies cured by surgery alone
* Carcinoma in situ of the cervix
* Adequately treated basal cell skin cancer
* No complete bowel obstruction
* No other concurrent severe medical condition that would preclude study participation
* No dementia or significantly altered mental status that would preclude study participation
* No concurrent severe active infection
* Geographically accessible for treatment and follow-up
PRIOR CONCURRENT THERAPY:
Biologic therapy
* No concurrent immunotherapy
Chemotherapy
* No prior chemotherapy
* No other concurrent chemotherapy
Endocrine therapy
* No concurrent hormonal therapy except:
* Hormone replacement therapy
* Antiemetic steroids
Radiotherapy
* No prior radiotherapy
* No concurrent radiotherapy
Surgery
* See Disease Characteristics
* Recovered from prior surgery
Other
* No other concurrent antineoplastic agents
* No other concurrent investigational drugs
* No other concurrent clinical trial enrollmentReferences
Publications (2)
- RESULTdu Bois A, Herrstedt J, Hardy-Bessard AC, Muller HH, Harter P, Kristensen G, Joly F, Huober J, Avall-Lundqvist E, Weber B, Kurzeder C, Jelic S, Pujade-Lauraine E, Burges A, Pfisterer J, Gropp M, Staehle A, Wimberger P, Jackisch C, Sehouli J. Phase III trial of carboplatin plus paclitaxel with or without gemcitabine in first-line treatment of epithelial ovarian cancer. J Clin Oncol. 2010 Sep 20;28(27):4162-9. doi: 10.1200/JCO.2009.27.4696. Epub 2010 Aug 23. PMID 20733132
- DERIVEDMachelon V, Gaudin F, Camilleri-Broet S, Nasreddine S, Bouchet-Delbos L, Pujade-Lauraine E, Alexandre J, Gladieff L, Arenzana-Seisdedos F, Emilie D, Prevot S, Broet P, Balabanian K. CXCL12 expression by healthy and malignant ovarian epithelial cells. BMC Cancer. 2011 Mar 16;11:97. doi: 10.1186/1471-2407-11-97. PMID 21410972