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NCT00501644 · ClinicalTrials.gov registry record · Phase 2
Chemoimmunotherapy Study for Patients With Epithelial Ovarian Cancer
A Phase 2 study, sponsored by M.D. Anderson Cancer Center.
- Completed
- Registry status
- Phase 2
- Development phase
- 59
- Enrollment target
NCT00501644: Completed Phase 2 study, sponsored by M.D. Anderson Cancer Center.
NCT00501644 is a Phase 2 study that has completed, run by M.D. Anderson Cancer Center. The registered enrollment target is 59 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (56% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00501644, a Phase 2 study, has completed, sponsored by M.D. Anderson Cancer Center.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 59 participants
- Enrollment target
Study Summary
Primary Objectives: 1. Determine response rate, time to progression, and toxicity of a schedule of carboplatin by IV (intravenous) infusion, GM-CSF and rIFN-g by SC (subcutaneous injection) in patients with potentially platinum-sensitive recurrent Müllerian carcinomas. 2. Determine whether this treatment schedule is associated with: 1. increased levels of monocytes (\>2-fold and absolute numbers 1000 cells/ml,) and of LN-DR+ DC (CD11c+ and CD123+ subsets) 2. induction of priming and activation of MO/MA (monocytes/ macrophages), and maturation of DC (dendritic cells). 3. Determine the toxicity profile of consolidation treatment with IP (intraperitoneal) injections of rIFN-g added to carboplatin (IV) and GM-CSF (SC) for 4 doses/course. 4. Determine the effects of carboplatin plus GM-CSF and rIFN-g on quality of life in patients with platinum-sensitive Müllerian carcinomas. 5. To begin an exploration of cell surface proteins on purified activated peripheral blood and ascites monocyte/macrophages both before and after treatment with GM-CSFand rIFN-g.
Primary Outcome
Per World Health Organization (WHO) Tumor Response: Complete Response (CR), Partial Response (PR) or Progressive Disease (PD). CR defined as disappearance of all target lesions, PR as \> = 30% decrease in sum of longest dimensions of target lesions with reference baseline sum longest dimensions and if CA 125 levels declined by \>50%, provided target lesion size did not increase by \>20% on imaging, and PD as \>20% increase in sum of longest dimensions of target lesions taking as references small
Interventions
- DRUG Carboplatin
- DRUG GM-CSF (Sargramostim)
- DRUG Interferon Gamma
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 59 participants |
| Start Date | 2003-01 |
| Est. Completion | 2009-01 |
| Phase | Phase 2 |
What the finished NCT00501644 record still lists
NCT00501644 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 59 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (56% lower).
The record links to 0 conditions, and to 3 interventions - of which Carboplatin is the first listed.
NCT00501644 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00501644 about?
NCT00501644 is a clinical study titled "Chemoimmunotherapy Study for Patients With Epithelial Ovarian Cancer". Primary Objectives: 1. Determine response rate, time to progression, and toxicity of a schedule of carboplatin by IV (intravenous) infusion, GM-CSF and rIFN-g by SC (subcutaneous injection) in patients with potentially platinum-sensitive recurrent Müllerian carcinomas. 2. Determine whether this tre...
What is the current status of trial NCT00501644?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 59 participants. The study started on 2003-01. Estimated completion is 2009-01.
What interventions are being tested in trial NCT00501644?
The interventions under investigation include: Carboplatin (DRUG), GM-CSF (Sargramostim) (DRUG), Interferon Gamma (DRUG).
Who is sponsoring clinical trial NCT00501644?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00501644's enrollment target sits among peer trials
59 1133rd of 2000 higher than 866 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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