Epithelial Ovarian CancerPhase 3MITO32NCT04421547
Efficacy of Letrozole in Recurrent Ovarian Cancer
A Phase 3 study testing Letrozole 2.5mg and Standard single agent chemotherapy in people with Epithelial Ovarian Cancer, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
Trial summary
Randomized phase III multicenter study investigating the role of letrozole in heavily pretreated recurrent ovarian cancer. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Epithelial Ovarian Cancer
- What is being tested?
- Letrozole 2.5mg and Standard single agent chemotherapy
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- 1 siteItaly
- Study dates
- 22 Jun 2020to 4 Nov 2024
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female of 18 years of age or older
- Histologically or cytologically documented invasive epithelial ovarian cancer, primary peritoneal carcinoma, or fallopian tube cancer
- Platinum resistant or refractory disease (patients who did not respond to last platinumbased therapy or with last relapse occurred < 6 months from the last dose of platinum) or patients not amenable of platinum treatment
- >3 previous chemotherapy lines
- ECOG performance status 0 -2
- Measurable and evaluable disease according to RECIST criteria confirmed by radiological imaging: at least one lesion of ≥ 1.0 cm for non-lymph nodes or ≥ 1.5 cm in short-axis diameter for lymph nodes at CT scan (Subjects with isolated rising CA-125 without radiologically visible disease are excluded)
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- Left Ventricular Ejection Fraction (LVEF) ≥ institutional lower limit normal
- Estimated life expectancy ≥ 16 weeks
- Adequate functions evidenced by:
- Hemoglobin ³10.0 g/dl
- Absolute neutrophil count ³1.5 x 109/L
- White blood cells >3x109/L
- Platelet >100 x109/L
- AST and ALT £ 2.5 x Upper limit of normal, unless liver metastasis, in which case AST and ALT < or = 5 x Upper limit of normal will be accepted
- Bilirubin ≤ 1.5 times the upper limit of normal (ULN)
- Estimated glomerular filtration ³ 60mL/min using the Cockcroft-Gault equation.
- Patient able to comply with the treatment
- Evidence of not pregnancy status as documented by a negative beta-human chorionic gonadotropin (ß-hCG) test
- Not breastfeeding women
- Patients with child-bearing potential using (or willing to use) effective contraception during treatment and 3 months ahead unless they are postmenopausal (at least 12 months consecutive amenorrhea, in the appropriate age group and without other known or suspected cause), or have been sterilized surgically.
- Comprehension and signature of the informed consent
Who cannot join
- Subjects with borderline ovarian cancer
- Subject with low malignant potential tumors
- Less than 3 lines of previous therapies
- Platinum sensitive disease (last relapse occurred > 6 months from the last dose of platinum)
- Less than 4 weeks from last dose of therapy with any investigational agent, or chemotherapy
- History of another neoplastic disease (except basal cell carcinoma or cervical carcinoma in situ adequately treated) unless in remission for 3 years or longer
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- Breastfeeding women
- Pregnant women
- Prior therapy with letrozole.
- Severe osteoporosis documented by BMD (Bone Mineral Density) T-score ≤ -2.5 with existing fragility fracture(s)
- Patients with a known hypersensitivity to Paclitaxel , PLD, Topotecan, Gemcitabine or Letrozole or any case of severe toxicity related to them. Also Patients with a known hypersensitivity to any of the ingredients or excipients of the IMPs (e.g. macrogolglycerol ricinoleate (polyoxyl castor oil), ethanol, anhydrous, citric acid, anhydrous, sodium chloride hydrochloric acid, mannitol, sodium acetate, sodium hydroxide, tartaric acid, lactose monohydrate, maize starch, hypromellose Type 2910, cellulose microcrystalline, sodium starch glycolate type A, colloidal anhydrous silica, magnesium stearate, hypromellose 6 cp E464, titanium dioxide E171, Iron oxide yellow E172, Macrogol 400, talc E553b)
- Prior resistance to Paclitaxel, PLD, Topotecan, Gemcitabine
- Patients with active hepatic disease (HCV or HBV infections), hepatic severe impairment or cirrhosis
- Bowel obstruction, sub-occlusive disease, prior gastrectomy, symptomatic brain metastases.
- Myocardial infarct within six months before enrolment , NYHA Class II or worse heart failure, unstable angina, serious cardiac arrhythmia or cardiac arrhythmia requiring treatment.
- Any serious concomitant illness requiring treatment
- Pre-existing peripheral neuropathy > CTCAE Grade 2.
- Concomitant use of strong CYP3A4 inhibitors (e.g. ketoconazole, itraconazole, voriconazole, ritonavir, clarithromycin, and telithromycin) or strong CYP2A6 inhibitors (e.g. methoxsalen) because they may increase exposure to letrozole.
- Concomitant use of inducers of CYP3A4 (e.g. phenytoin, rifampicin, carbamazepine, phenobarbital, and St. John's Wort) which may reduce exposure to letrozole.
- Concomitant use of medicinal products with a narrow therapeutic index that are substrates for CYP2C19 (e.g. phenytoin, clopidrogel) that may have their systemic serum concentrations altered by letrozole.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase III Randomized Control Case Study of Letrozole in Women With Heavily Pretreated Ovarian Cancer (MITO32)
Randomized phase III multicenter study investigating the role of letrozole in heavily pretreated recurrent ovarian cancer.
Read the detailed description
This is a randomized, open-label, phase III, multicenter, global study evaluating the efficacy and safety of Letrozole in heavily pretreated recurrent ovarian cancer patients in comparison to physician' choice chemotherapy.
Subjects who meet all the inclusion criteria and none of the exclusion criteria will be randomized in a 1:1 ratio to one of the two arms, as follow:
Arm A: Letrozole 1 tablet (2,5 mg) orally once a day in 28-day cycles Arm B: Pegylated Liposomal Doxorubicin 40 mg/m2 d1q28 or Topotecan 4 mg/m2 d1,8,15q28 or Gemcitabine 1000 mg/m2 d1,8,15q28 or Paclitaxel 80 mg/m2 d1,8,15q28 In case of objective response and acceptable toxicity, no maximum number of cycles of treatment is defined.
The aim of the study is to assess the activity of Letrozole in women with recurrent epithelial ovarian cancer, heavily pretreated.
- Conditions
- Epithelial Ovarian Cancer
- Being tested
- Letrozole 2.5mg, Standard single agent chemotherapy
- Keywords
- epithelial ovarian cancer, Letrozole
- Medical subject headings
- Carcinoma, Ovarian Epithelial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Letrozole 2.5mgDrug
This study will investigate the role of Letrozole in patients affected by heavily pretreated platinum resistant ovarian cancer, compared to standard treatment.
Standard single agent chemotherapyDrug
Either Paclitaxel 80 mg/m2 as a 1-h infusion, on days 1,8,15,22 every 28 days or Pegylated Liposomal Doxorubicin (PLD) 40 mg/m2 given every 4 weeks or Topotecan 4mg/m2 IV on days 1,8,15 every 4 weeks or Gemcitabine 1000 mg/m2 IV over 30 min on days 1,8,15 every 28 days.
| Study group | Role | What they receive |
|---|---|---|
| Letrozole | Experimental | Letrozole 1 tablet (2,5 mg) orally once a day Receives: Drug: Letrozole 2.5mg |
| Standard Chemotherapy | Active comparator | Either Paclitaxel 80 mg/m2 as a 1-h infusion, on days 1,8,15,22 every 28 days or Pegylated Liposomal Doxorubicin (PLD) 40 mg/m2 given every 4 weeks or Topotecan 4mg/m2 IV on days 1,8,15 every 4 weeks or Gemcitabine 1000 mg/m2 IV over 30 min on days 1,8,15 every 28 days. Receives: Drug: Standard single agent chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patient alive at 12 months
Evaluate the difference in terms of proportion of survivals at 12 months between the two arms.
Measured: 30 months
Secondary outcomes (7)
PFS
Progression Free Survival
Measured: 30 months
OS
Overall Survival
Measured: 30 months
ORR
Objective Response Rate (according to RECIST criteria version 1.1)
Measured: 30 months
TPST
Time from randomization to the start of the primary subsequent therapy
Measured: 30 months
TSST
Time from randomization to the start of the secondary subsequent therapy
Measured: 30 months
Toxicity profile evaluated according to NCI-CTCAE version 5.0
Toxicity profile (evaluated according to NCI-CTCAE version 5.0)
Measured: 30 months
QoL
Quality of Life (evaluated by EORTC QLQ-C30/ QLQ-OV28 questionnaire)
Measured: 30 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2020
- Study start22 Jun 2020
- Primary completion1 Nov 2024
- Study completion4 Nov 2024
Why it stopped: Logistical problems impacting the speed of enrolment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (33)Papers the sponsor has linked to this study.
- Other trials for Epithelial Ovarian CancerStudies of the same condition, open and under way.
- More trials run by Fondazione Policlinico Universitario Agostino Gemelli IRCCSThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a two arms, prospective, open-label multi center randomized phase III study.
- Masking
- None (open label)
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, MARCHETTI CLAUDIA, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Investigators
- Claudia Marchetti, Principal investigator, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04421547
- Sponsor's protocol ID
- MITO32
- Acronym
- MITO32
- Status last verified
- Mar 2025
- First submitted
- 15 May 2020
- Last updated
- 7 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Banerjee S, Kaye SB, Ashworth A. Making the best of PARP inhibitors in ovarian cancer. Nat Rev Clin Oncol. 2010 Sep;7(9):508-19. doi: 10.1038/nrclinonc.2010.116. Epub 2010 Aug 10.
PubMed 20700108Banerjee S, Kaye SB. New strategies in the treatment of ovarian cancer: current clinical perspectives and future potential. Clin Cancer Res. 2013 Mar 1;19(5):961-8. doi: 10.1158/1078-0432.CCR-12-2243. Epub 2013 Jan 10.
PubMed 23307860Gore ME, Fryatt I, Wiltshaw E, Dawson T. Treatment of relapsed carcinoma of the ovary with cisplatin or carboplatin following initial treatment with these compounds. Gynecol Oncol. 1990 Feb;36(2):207-11. doi: 10.1016/0090-8258(90)90174-j.
PubMed 2404837Markman M, Rothman R, Hakes T, Reichman B, Hoskins W, Rubin S, Jones W, Almadrones L, Lewis JL Jr. Second-line platinum therapy in patients with ovarian cancer previously treated with cisplatin. J Clin Oncol. 1991 Mar;9(3):389-93. doi: 10.1200/JCO.1991.9.3.389.
PubMed 1999708Buda A, Floriani I, Rossi R, Colombo N, Torri V, Conte PF, Fossati R, Ravaioli A, Mangioni C. Randomised controlled trial comparing single agent paclitaxel vs epidoxorubicin plus paclitaxel in patients with advanced ovarian cancer in early progression after platinum-based chemotherapy: an Italian Collaborative Study from the Mario Negri Institute, Milan, G.O.N.O. (Gruppo Oncologico Nord Ovest) group and I.O.R. (Istituto Oncologico Romagnolo) group. Br J Cancer. 2004 Jun 1;90(11):2112-7. doi: 10.1038/sj.bjc.6601787.
PubMed 15150623Sehouli J, Stengel D, Oskay-Oezcelik G, Zeimet AG, Sommer H, Klare P, Stauch M, Paulenz A, Camara O, Keil E, Lichtenegger W. Nonplatinum topotecan combinations versus topotecan alone for recurrent ovarian cancer: results of a phase III study of the North-Eastern German Society of Gynecological Oncology Ovarian Cancer Study Group. J Clin Oncol. 2008 Jul 1;26(19):3176-82. doi: 10.1200/JCO.2007.15.1258.
PubMed 18591555ten Bokkel Huinink W, Gore M, Carmichael J, Gordon A, Malfetano J, Hudson I, Broom C, Scarabelli C, Davidson N, Spanczynski M, Bolis G, Malmstrom H, Coleman R, Fields SC, Heron JF. Topotecan versus paclitaxel for the treatment of recurrent epithelial ovarian cancer. J Clin Oncol. 1997 Jun;15(6):2183-93. doi: 10.1200/JCO.1997.15.6.2183.
PubMed 9196130Gordon AN, Fleagle JT, Guthrie D, Parkin DE, Gore ME, Lacave AJ. Recurrent epithelial ovarian carcinoma: a randomized phase III study of pegylated liposomal doxorubicin versus topotecan. J Clin Oncol. 2001 Jul 15;19(14):3312-22. doi: 10.1200/JCO.2001.19.14.3312.
PubMed 11454878Mutch DG, Orlando M, Goss T, Teneriello MG, Gordon AN, McMeekin SD, Wang Y, Scribner DR Jr, Marciniack M, Naumann RW, Secord AA. Randomized phase III trial of gemcitabine compared with pegylated liposomal doxorubicin in patients with platinum-resistant ovarian cancer. J Clin Oncol. 2007 Jul 1;25(19):2811-8. doi: 10.1200/JCO.2006.09.6735.
PubMed 17602086Vergote I, Finkler NJ, Hall JB, Melnyk O, Edwards RP, Jones M, Keck JG, Meng L, Brown GL, Rankin EM, Burke JJ, Boccia RV, Runowicz CD, Rose PG. Randomized phase III study of canfosfamide in combination with pegylated liposomal doxorubicin compared with pegylated liposomal doxorubicin alone in platinum-resistant ovarian cancer. Int J Gynecol Cancer. 2010 Jul;20(5):772-80. doi: 10.1111/igc.0b013e3181daaf59.
PubMed 20973267Pujade-Lauraine E, Hilpert F, Weber B, Reuss A, Poveda A, Kristensen G, Sorio R, Vergote I, Witteveen P, Bamias A, Pereira D, Wimberger P, Oaknin A, Mirza MR, Follana P, Bollag D, Ray-Coquard I. Bevacizumab combined with chemotherapy for platinum-resistant recurrent ovarian cancer: The AURELIA open-label randomized phase III trial. J Clin Oncol. 2014 May 1;32(13):1302-8. doi: 10.1200/JCO.2013.51.4489. Epub 2014 Mar 17.
PubMed 24637997Lakusta CM, Atkinson MJ, Robinson JW, Nation J, Taenzer PA, Campo MG. Quality of life in ovarian cancer patients receiving chemotherapy. Gynecol Oncol. 2001 Jun;81(3):490-5. doi: 10.1006/gyno.2001.6199.
PubMed 11371144Demers LM, Melby JC, Wilson TE, Lipton A, Harvey HA, Santen RJ. The effects of CGS 16949A, an aromatase inhibitor on adrenal mineralocorticoid biosynthesis. J Clin Endocrinol Metab. 1990 Apr;70(4):1162-6.
PubMed 2156889Lipton A, Demers LM, Harvey HA, Kambic KB, Grossberg H, Brady C, Adlercruetz H, Trunet PF, Santen RJ. Letrozole (CGS 20267). A phase I study of a new potent oral aromatase inhibitor of breast cancer. Cancer. 1995 Apr 15;75(8):2132-8. doi: 10.1002/1097-0142(19950415)75:83.0.co;2-u.
PubMed 7697604El Ouagari K, Karnon J, Delea T, Talbot W, Brandman J. Cost-effectiveness of letrozole in the extended adjuvant treatment of women with early breast cancer. Breast Cancer Res Treat. 2007 Jan;101(1):37-49. doi: 10.1007/s10549-006-9262-4. Epub 2006 Jul 4.
PubMed 16821085
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase III Randomized Control Case Study of Letrozole in Women With Heavily Pretreated Ovarian Cancer (MITO32)
- ClinicalTrials.gov ID
- NCT04421547
- Acronym / sponsor ID
- MITO32 / MITO32
- Conditions
- Epithelial Ovarian Cancer
- Keywords
- epithelial ovarian cancer, Letrozole
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Logistical problems impacting the speed of enrolment
- Enrolment
- 86 participants (actual)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- 22 Jun 2020 (actual)
- Primary completion
- 1 Nov 2024 (actual)
- Study completion
- 4 Nov 2024 (actual)
- First posted
- 9 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Randomized phase III multicenter study investigating the role of letrozole in heavily pretreated recurrent ovarian cancer.
Detailed description
This is a randomized, open-label, phase III, multicenter, global study evaluating the efficacy and safety of Letrozole in heavily pretreated recurrent ovarian cancer patients in comparison to physician' choice chemotherapy.
Subjects who meet all the inclusion criteria and none of the exclusion criteria will be randomized in a 1:1 ratio to one of the two arms, as follow:
Arm A: Letrozole 1 tablet (2,5 mg) orally once a day in 28-day cycles Arm B: Pegylated Liposomal Doxorubicin 40 mg/m2 d1q28 or Topotecan 4 mg/m2 d1,8,15q28 or Gemcitabine 1000 mg/m2 d1,8,15q28 or Paclitaxel 80 mg/m2 d1,8,15q28 In case of objective response and acceptable toxicity, no maximum number of cycles of treatment is defined.
The aim of the study is to assess the activity of Letrozole in women with recurrent epithelial ovarian cancer, heavily pretreated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is a two arms, prospective, open-label multi center randomized phase III study.
| Arm | Type | Receives |
|---|---|---|
| Letrozole | Experimental | Drug: Letrozole 2.5mgLetrozole 1 tablet (2,5 mg) orally once a day |
| Standard Chemotherapy | Active comparator | Drug: Standard single agent chemotherapyEither Paclitaxel 80 mg/m2 as a 1-h infusion, on days 1,8,15,22 every 28 days or Pegylated Liposomal Doxorubicin (PLD) 40 mg/m2 given every 4 weeks or Topotecan 4mg/m2 IV on days 1,8,15 every 4 weeks or Gemcitabine 1000 mg/m2 IV over 30 min on days 1,8,15 every 28 days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- Female of 18 years of age or older
- Histologically or cytologically documented invasive epithelial ovarian cancer, primary peritoneal carcinoma, or fallopian tube cancer
- Platinum resistant or refractory disease (patients who did not respond to last platinumbased therapy or with last relapse occurred < 6 months from the last dose of platinum) or patients not amenable of platinum treatment
- >3 previous chemotherapy lines
- ECOG performance status 0 -2
Key exclusion criteria (20 listed)
- Subjects with borderline ovarian cancer
- Subject with low malignant potential tumors
- Less than 3 lines of previous therapies
- Platinum sensitive disease (last relapse occurred > 6 months from the last dose of platinum)
- Less than 4 weeks from last dose of therapy with any investigational agent, or chemotherapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Letrozole 2.5mgThis study will investigate the role of Letrozole in patients affected by heavily pretreated platinum resistant ovarian cancer, compared to standard treatment. | Drug | Letrozole |
| Standard single agent chemotherapyEither Paclitaxel 80 mg/m2 as a 1-h infusion, on days 1,8,15,22 every 28 days or Pegylated Liposomal Doxorubicin (PLD) 40 mg/m2 given every 4 weeks or Topotecan 4mg/m2 IV on days 1,8,15 every 4 weeks or Gemcitabine 1000 mg/m2 IV over 30 min on days 1,8,15 every 28 days. | Drug | Standard Chemotherapy |
Primary outcome
Proportion of patient alive at 12 months
Time frame: 30 months
Evaluate the difference in terms of proportion of survivals at 12 months between the two arms.
7 secondary outcomes
PFS
Time frame: 30 months
OS
Time frame: 30 months
ORR
Time frame: 30 months
TPST
Time frame: 30 months
TSST
Time frame: 30 months
Toxicity profile evaluated according to NCI-CTCAE version 5.0
Time frame: 30 months
QoL
Time frame: 30 months
Results and safety
The study was stopped early (reason given: Logistical problems impacting the speed of enrolment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2025.
- Background: PubMed 20700108Banerjee S, Kaye SB, Ashworth A. Making the best of PARP inhibitors in ovarian cancer. Nat Rev Clin Oncol. 2010 Sep;7(9):508-19. doi: 10.1038/nrclinonc.2010.116. Epub 2010 Aug 10.
- Background: PubMed 23307860Banerjee S, Kaye SB. New strategies in the treatment of ovarian cancer: current clinical perspectives and future potential. Clin Cancer Res. 2013 Mar 1;19(5):961-8. doi: 10.1158/1078-0432.CCR-12-2243. Epub 2013 Jan 10.
- Background: PubMed 2404837Gore ME, Fryatt I, Wiltshaw E, Dawson T. Treatment of relapsed carcinoma of the ovary with cisplatin or carboplatin following initial treatment with these compounds. Gynecol Oncol. 1990 Feb;36(2):207-11. doi: 10.1016/0090-8258(90)90174-j.
- Background: PubMed 1999708Markman M, Rothman R, Hakes T, Reichman B, Hoskins W, Rubin S, Jones W, Almadrones L, Lewis JL Jr. Second-line platinum therapy in patients with ovarian cancer previously treated with cisplatin. J Clin Oncol. 1991 Mar;9(3):389-93. doi: 10.1200/JCO.1991.9.3.389.
- Background: PubMed 15150623Buda A, Floriani I, Rossi R, Colombo N, Torri V, Conte PF, Fossati R, Ravaioli A, Mangioni C. Randomised controlled trial comparing single agent paclitaxel vs epidoxorubicin plus paclitaxel in patients with advanced ovarian cancer in early progression after platinum-based chemotherapy: an Italian Collaborative Study from the Mario Negri Institute, Milan, G.O.N.O. (Gruppo Oncologico Nord Ovest) group and I.O.R. (Istituto Oncologico Romagnolo) group. Br J Cancer. 2004 Jun 1;90(11):2112-7. doi: 10.1038/sj.bjc.6601787.
- Background: PubMed 18591555Sehouli J, Stengel D, Oskay-Oezcelik G, Zeimet AG, Sommer H, Klare P, Stauch M, Paulenz A, Camara O, Keil E, Lichtenegger W. Nonplatinum topotecan combinations versus topotecan alone for recurrent ovarian cancer: results of a phase III study of the North-Eastern German Society of Gynecological Oncology Ovarian Cancer Study Group. J Clin Oncol. 2008 Jul 1;26(19):3176-82. doi: 10.1200/JCO.2007.15.1258.
- Background: PubMed 9196130ten Bokkel Huinink W, Gore M, Carmichael J, Gordon A, Malfetano J, Hudson I, Broom C, Scarabelli C, Davidson N, Spanczynski M, Bolis G, Malmstrom H, Coleman R, Fields SC, Heron JF. Topotecan versus paclitaxel for the treatment of recurrent epithelial ovarian cancer. J Clin Oncol. 1997 Jun;15(6):2183-93. doi: 10.1200/JCO.1997.15.6.2183.
- Background: PubMed 11454878Gordon AN, Fleagle JT, Guthrie D, Parkin DE, Gore ME, Lacave AJ. Recurrent epithelial ovarian carcinoma: a randomized phase III study of pegylated liposomal doxorubicin versus topotecan. J Clin Oncol. 2001 Jul 15;19(14):3312-22. doi: 10.1200/JCO.2001.19.14.3312.
- Background: PubMed 17602086Mutch DG, Orlando M, Goss T, Teneriello MG, Gordon AN, McMeekin SD, Wang Y, Scribner DR Jr, Marciniack M, Naumann RW, Secord AA. Randomized phase III trial of gemcitabine compared with pegylated liposomal doxorubicin in patients with platinum-resistant ovarian cancer. J Clin Oncol. 2007 Jul 1;25(19):2811-8. doi: 10.1200/JCO.2006.09.6735.
- Background: PubMed 20973267Vergote I, Finkler NJ, Hall JB, Melnyk O, Edwards RP, Jones M, Keck JG, Meng L, Brown GL, Rankin EM, Burke JJ, Boccia RV, Runowicz CD, Rose PG. Randomized phase III study of canfosfamide in combination with pegylated liposomal doxorubicin compared with pegylated liposomal doxorubicin alone in platinum-resistant ovarian cancer. Int J Gynecol Cancer. 2010 Jul;20(5):772-80. doi: 10.1111/igc.0b013e3181daaf59.
- Background: PubMed 24637997Pujade-Lauraine E, Hilpert F, Weber B, Reuss A, Poveda A, Kristensen G, Sorio R, Vergote I, Witteveen P, Bamias A, Pereira D, Wimberger P, Oaknin A, Mirza MR, Follana P, Bollag D, Ray-Coquard I. Bevacizumab combined with chemotherapy for platinum-resistant recurrent ovarian cancer: The AURELIA open-label randomized phase III trial. J Clin Oncol. 2014 May 1;32(13):1302-8. doi: 10.1200/JCO.2013.51.4489. Epub 2014 Mar 17.
- Background: PubMed 11371144Lakusta CM, Atkinson MJ, Robinson JW, Nation J, Taenzer PA, Campo MG. Quality of life in ovarian cancer patients receiving chemotherapy. Gynecol Oncol. 2001 Jun;81(3):490-5. doi: 10.1006/gyno.2001.6199.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Claudia Marchetti principal investigator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Letrozole 2.5mg and Standard single agent chemotherapy in people with Epithelial Ovarian Cancer, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 21 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 7 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Logistical problems impacting the speed of enrolment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patient alive at 12 months (time frame: 30 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04421547, which also lists 33 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Mar 2025.