Phase 2
N=30
Gemcitabine and Docetaxel in Treating Patients With Relapsed or Refractory Ovarian Epithelial or Peritoneal Cancer
Ovarian Cancer · Peritoneal Cavity Cancer
Bottom Line
View on ClinicalTrials.gov: NCT00227721 ↗Enrolled (actual)
30
Serious AEs
48.3%
Results posted
Feb 2015
Primary outcome: Primary: Response Rate to the Combination of Gemcitabine and Docetaxel in Patients With Platinum Sensitive and Resistant Epithelial Ovarian or Peritoneal Cancer. — 62 percentage of participants with CR or PR
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Docetaxel (Drug); Gemcitabine hydrochloride (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Robert Morris
- Primary completion
- Jun 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Response Rate to the Combination of Gemcitabine and Docetaxel in Patients With Platinum Sensitive and Resistant Epithelial Ovarian or Peritoneal Cancer. |
62 | — |
| SECONDARY Progression-free Survival |
7.2 | — |
Summary
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.
Eligibility Criteria
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 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 cancer
Data sourced from ClinicalTrials.gov (NCT00227721). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.