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This trial is complete. It is no longer accepting participants. Results may be available on ClinicalTrials.gov.

NCT01111903

NCT01111903
Completed Phase 2

Who may be able to join

Who might be able to join this trial:

  • You are over 18 years old.
  • You have been diagnosed with epithelial ovarian cancer, fallopian tube cancer, or a related type called extra-ovarian papillary serous tumor, confirmed by a tissue sample (biopsy).
  • Your cancer has come back or gotten worse more than 6 months after receiving a treatment plan that included a platinum-based drug (such as carboplatin or cisplatin).
  • You have previously been treated with a taxane-based drug (such as paclitaxel or docetaxel).
  • Your cancer progression has been detected through rising CA-125 blood marker levels and/or visible tumors on scans.
  • Your blood counts, kidney function, and liver function are within acceptable levels (the trial team will check this with blood tests).
  • You are generally well enough to carry out normal daily activities, with little or no limitation (confirmed by a doctor's assessment).
  • You are expected to live for at least 16 weeks.
  • For one part of the trial (Stage B): your heart pumping function is within a certain range (confirm with trial site).
  • For one part of the trial (Stage B): if you were already in Stage A of this trial on a drug called lenalidomide and your disease got worse but you did not have serious side effects, you may be eligible after stopping lenalidomide for 7 days.
  • You are willing and able to give written informed consent after being fully informed about the trial.

Who may not be able to join:

  • Your ovarian tumor is classified as "borderline" (low malignant potential) rather than fully cancerous.
  • Your tumor is a non-epithelial type or a mixed type (such as mixed Mullerian tumor).
  • You have been diagnosed with another cancer in the last 5 years that required more than surgery alone to treat (exceptions may apply for certain minor skin cancers or cervical in-situ carcinoma — confirm with trial site).
  • You have previously had radiotherapy.
  • You have brain metastases (cancer that has spread to the brain) that are causing symptoms.
  • You have a history of seizures, a central nervous system disorder, or existing nerve-related symptoms (such as numbness or weakness) above a mild level.
  • You have a history of significant heart failure, a heart attack in the last 6 months, or certain types of heart rhythm problems.
  • You have had a blood clot or have been on blood-thinning treatment within the last 6 months.
  • You have had internal bleeding or a stomach/intestinal ulcer within the last 6 months.
  • You have a bowel blockage or partial blockage.
  • You have a serious active infection.
  • You have another serious medical condition (unrelated to cancer) that could put you at significant risk or prevent you from fully participating in the study.
  • You are a woman who could become pregnant and is not using adequate contraception, or you are currently pregnant or breastfeeding.
  • You have a known allergy to carboplatin, pegylated liposomal doxorubicin, lenalidomide, or any of their ingredients.
  • You have previously had a severe skin reaction (a blistering or peeling rash) while taking thalidomide or a similar drug.
  • You have previously been treated with lenalidomide.
  • You are known to be HIV-positive, have AIDS-related illness, or have active Hepatitis A, B, or C.
  • You are currently receiving other chemotherapy, hormone therapy (except hormone replacement therapy or steroid anti-sickness medications), or radiotherapy at the same time as this trial treatment.
  • You have dementia or a significantly impaired mental state that would prevent you from understanding and consenting to the trial.

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

Phase 2: approximately ~30% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.

Trial details

Status
Completed
Phase
Phase 2
Sponsor
ARCAGY/ GINECO GROUP
Registry
clinicaltrials_gov
Start date
1 May 2009
Est. completion
1 December 2014

Where this trial is recruiting

🇫🇷 France

Primary endpoints

Efficacy of lenalidomide as single agent, then DMT of lenalidomise with carboplatin and pegylated liposomal doxorubicin

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 30 June 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

View original record on ClinicalTrials.gov