Clinical trial · Interventional
Gemcitabine and Docetaxel in Treating Patients With Relapsed or Refractory Ovarian Epithelial or Peritoneal Cancer
Phase II Trial of Weekly Gemcitabine and Docetaxel Combination Therapy for Relapsed Ovarian or Peritoneal Cancer
NCT00227721CI-TRIAL-00048607completedPhase 2Results postedClinicalTrials.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, such as gemcitabine and docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving gemcitabine together with docetaxel works in treating patients with relapsed or refractory ovarian epithelial or peritoneal 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 |
|---|---|---|---|
| Ovarian Cancer | Malignant Ovarian Neoplasm | CURATED_EXACT | 0.92 |
| Peritoneal Cavity Cancer | Malignant Peritoneal Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Docetaxel | Drug | Docetaxel | ALIAS |
| Gemcitabine hydrochloride | Drug | Gemcitabine | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Docetaxel & Gemcitabine hydrochloride
- description
- Docetaxel, 40 mg/m2, 30 min IV infusion on Days 1 and 8, of a 21 day cycle Gemcitabine hydrochloride, 800mg/m2 30 min IV infusion on Days1 and 8, of a 21 day cycle
- interventionNames
- Drug: Docetaxel
- Drug: Gemcitabine hydrochloride
Primary outcomes (1)
- measure
- Response Rate to the Combination of Gemcitabine and Docetaxel in Patients With Platinum Sensitive and Resistant Epithelial Ovarian or Peritoneal Cancer.
- timeFrame
- Disease status by Response Evaluation Criteria In Solid Tumors Criteria (RECIST) or Gynecological Cancer Intergroup (GCIG) CA-125 criteria was assessed every two cycles from enrollment up to progression, death, or five years (whichever occurred first).
Secondary outcomes (1)
- measure
- Progression-free Survival
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 120 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Histologically confirmed ovarian epithelial or peritoneal cavity cancer
* Relapsed or refractory disease after prior first-line therapy with a platinum-containing regimen
* Platinum-sensitive or -resistant disease
* Platinum resistance is defined as relapsed or progressive disease within 6 months after completion of a platinum-containing regimen
* Measurable or evaluable disease
* Evaluable disease is defined as CA 125 \> 70 U/mL that has doubled from a baseline determination confirmed by ≥ 2 separate blood samples taken \> 4 weeks apart OR other evidence demonstrating progressive disease after initial treatment regimen
PATIENT CHARACTERISTICS:
Age
* 18 and over
Performance status
* ECOG 0-2
Life expectancy
* Not specified
Hematopoietic
* WBC ≥ 3,000/mm\^3
* Absolute neutrophil count ≥ 1,500/mm\^3
* Platelet count ≥ 100,000/mm\^3
* Hemoglobin ≥ 8.0 g/dL
Hepatic
* Bilirubin normal
* Meets 1 of the following criteria:
* AST or ALT normal AND alkaline phosphatase (AP) ≤ 5 times upper limit of normal (ULN)
* AST or ALT ≤ 1.5 times ULN AND AP ≤ 2.5 times ULN
* AST or ALT ≤ 5 times ULN AND AP normal
Renal
* Creatinine clearance \> 30 mL/min
* Creatinine \< 2.5 mg/dL
Cardiovascular
* No congestive heart failure
* No second or third degree heart block
* No myocardial infarction within the past 3 months
Other
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No peripheral neuropathy \> grade 1
* No other malignancy within the past 2 years except adequately treated skin cancer or carcinoma in situ of the cervix
* No history of severe hypersensitivity reaction to drugs formulated with polysorbate 80
PRIOR CONCURRENT THERAPY:
Biologic therapy
* Not specified
Chemotherapy
* See Disease Characteristics
* Prior paclitaxel allowed
* No more than 1 prior chemotherapy regimen
* First-line platinum-based chemotherapy followed by consolidation therapy in the setting of a clinical and serologic complete response is considered 1 regimen
* No prior gemcitabine or docetaxel
Endocrine therapy
* Not specified
Radiotherapy
* At least 4 weeks since prior radiotherapy and recovered
Surgery
* Not specified
Other
* More than 28 days since prior and no other concurrent investigational drugs for this cancer
* No other concurrent treatment or alternative therapy for this cancerReferences
Publications (0)
Data not yet available
No reference posted for this study.