A Phase 2 interventional study of gemcitabine and cisplatin in Ovarian Cancer, sponsored by Eli Lilly and Company. Completed at 5 sites in Russian Federation. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2009-03-27.
Sponsored by Eli Lilly and Company · Phase 2, Interventional, and Treatment
The primary endpoint of this study is to assess the objective tumor response rate in patients with advanced epithelial ovarian cancer receiving combination of Gemcitabine at a dose 1250 mg/m2 (Day 1 and 8) with Cisplatin 75 mg/m2 (Day 1) as first-line treatment
2,695 studies on the registry are indexed under Ovarian Neoplasms; 727 are open to participants now.
This study's enrollment of 50 is below the median of 60 across 2,030 interventional studies indexed under Ovarian Neoplasms.
Browse Ovarian Neoplasms studies →Eli Lilly and Company is the lead sponsor of 2,048 studies on the registry; 139 are open to participants now.
Of its 521 completed or terminated interventional studies of FDA-regulated products, 341 (65%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Drug: gemcitabine · Drug: cisplatin
1250 mg/m2, intravenous (IV) day 1 and day 8, every 21 days x 6 cycles or disease progression or unacceptable toxicity
Also known as: LY188011, Gemzar
75 mg/m2, intravenous (IV), every 21 days x 6 cycles or disease progression or unacceptable toxicity
Best Overall Tumor Response
Best response recorded from the start of treatment until disease progression/recurrence (taking as reference for progressive disease the smallest measurements recorded since the treatment started).
Time frame: every other 21 day cycle (6-8 cycles), every 3 months during long-term follow-up
Duration of Response
The duration of a complete response (CR) or partial response (PR) was defined as the time from first objective status assessment of CR or PR to the first time of progression or death as a result of any cause.
Time frame: every other 21 day cycle (6-8 cycles) and every 3 months during long-term follow-up
Time to Progressive Disease
Defined as the time from study enrollment to the first date of disease progression. Time to disease progression was censored at the date of death if death was due to other cause.
Time frame: every other 21 day cycle (6-8 cycles) and every 3 months during long-term follow-up
Time to Treatment Failure
Defined as the time from study enrollment to the first observation of disease progression, death as a result of any cause, or early discontinuation of treatment. Time to treatment failure was censored at the date of the last follow-up visit for patients who did not discontinue early, who were still alive, and who have not progressed.
Time frame: every other 21 day cycle (6-8 cycles) and every 3 months during long-term follow-up
Number of Patients With Maximum Common Toxicity Criteria - National Cancer Institute (CTC-NCI): Possibly Related to Study Drug by Grade
Grades range from 0 (no toxicity) to 4 (life-threatening or disabling).
Time frame: every 21 day cycle (6-8 cycles) and every 3 months during long-term follow-up
| Milestone | Gemcitabine + Cisplatin |
|---|---|
| Started | 50 |
| Completed | 33 |
| Not completed | 17 |
| Withdrew: Adverse event | 4 |
| Withdrew: Disease progression or relapse | 8 |
| Withdrew: Physician decision | 1 |
| Withdrew: Withdrawal by subject | 4 |
Best response recorded from the start of treatment until disease progression/recurrence (taking as reference for progressive disease the smallest measurements recorded since the treatment started).
| participants | Gemcitabine + Cisplatin |
|---|---|
| Complete Response | 6 |
| Partial Response | 25 |
| Stable Disease | 10 |
| Progressive Disease | 5 |
| Not Assessed | 4 |
The duration of a complete response (CR) or partial response (PR) was defined as the time from first objective status assessment of CR or PR to the first time of progression or death as a result of any cause.
| weeks | Gemcitabine + Cisplatin |
|---|---|
| Duration of Response | 37.0 (31.1 to 51.1) |
Defined as the time from study enrollment to the first date of disease progression. Time to disease progression was censored at the date of death if death was due to other cause.
| weeks | Gemcitabine + Cisplatin |
|---|---|
| Time to Progressive Disease | 45.1 (37.9 to 56.9) |
Defined as the time from study enrollment to the first observation of disease progression, death as a result of any cause, or early discontinuation of treatment. Time to treatment failure was censored at the date of the last follow-up visit for patients who did not discontinue early, who were still alive, and who have not progressed.
| weeks | Gemcitabine + Cisplatin |
|---|---|
| Time to Treatment Failure | 38.4 (29.1 to 48.3) |
Grades range from 0 (no toxicity) to 4 (life-threatening or disabling).
| participants | Gemcitabine + Cisplatin |
|---|---|
| Patients with at least one CTC - Grade 1 | 34 |
| Patients with at least one CTC - Grade 2 | 6 |
| Patients with at least one CTC - Grade 3 | 2 |
| Patients with at least one CTC - Grade 4 | 1 |
| Other auditory/hearing - Grade 1 | 0 |
| Other auditory/hearing - Grade 2 | 0 |
| Other auditory/hearing - Grade 3 | 1 |
| Other auditory/hearing - Grade 4 | 0 |
| Leukocytes - Grade 1 | 0 |
| Leukocytes - Grade 2 | 0 |
| Leukocytes - Grade 3 | 0 |
| Leukocytes - Grade 4 | 1 |
| Neutrophils/granulocytes - Grade 1 | 0 |
| Neutrophils/granulocytes - Grade 2 | 0 |
| Neutrophils/granulocytes - Grade 3 | 0 |
| Neutrophils/granulocytes - Grade 4 | 1 |
| Fatigue - Grade 1 | 11 |
| Fatigue - Grade 2 | 0 |
| Fatigue - Grade 3 | 1 |
| Fatigue - Grade 4 | 0 |
| Weight loss - Grade 1 | 0 |
| Weight loss - Grade 2 | 1 |
| Weight loss - Grade 3 | 0 |
| Weight loss - Grade 4 | 0 |
| Alopecia - Grade 1 | 1 |
| Alopecia - Grade 2 | 1 |
| Alopecia - Grade 3 | 0 |
| Alopecia - Grade 4 | 0 |
| Rash/desquamation - Grade 1 | 2 |
| Rash/desquamation - Grade 2 | 0 |
| Rash/desquamation - Grade 3 | 1 |
| Rash/desquamation - Grade 4 | 0 |
| Anorexia - Grade 1 | 1 |
| Anorexia - Grade 2 | 0 |
| Anorexia - Grade 3 | 0 |
| Anorexia - Grade 4 | 0 |
| Diarrhea (without colostomy) - Grade 1 | 0 |
| Diarrhea (without colostomy) - Grade 2 | 0 |
| Diarrhea (without colostomy) - Grade 3 | 1 |
| Diarrhea (without colostomy) - Grade 4 | 0 |
| Nausea - Grade 1 | 29 |
| Nausea - Grade 2 | 2 |
| Nausea - Grade 3 | 0 |
| Nausea - Grade 4 | 0 |
| Other Gastrointestinal - Grade 1 | 0 |
| Other Gastrointestinal - Grade 2 | 1 |
| Other Gastrointestinal - Grade 3 | 0 |
| Other Gastrointestinal - Grade 4 | 0 |
| Stomatitis/pharyngitis - Grade 1 | 0 |
| Stomatitis/pharyngitis - Grade 2 | 0 |
| Stomatitis/pharyngitis - Grade 3 | 1 |
| Stomatitis/pharyngitis - Grade 4 | 0 |
| Vomiting - Grade 1 | 24 |
| Vomiting - Grade 2 | 0 |
| Vomiting - Grade 3 | 0 |
| Vomiting - Grade 4 | 0 |
| Alkaline phosphatase - Grade 1 | 13 |
| Alkaline phosphatase - Grade 2 | 1 |
| Alkaline phosphatase - Grade 3 | 0 |
| Alkaline phosphatase - Grade 4 | 0 |
| Bilirubin - Grade 1 | 6 |
| Bilirubin - Grade 2 | 0 |
| Bilirubin - Grade 3 | 0 |
| Bilirubin - Grade 4 | 0 |
| Serum glutamic oxaloacetic transaminase - Grade 1 | 8 |
| Serum glutamic oxaloacetic transaminase - Grade 2 | 0 |
| Serum glutamic oxaloacetic transaminase - Grade 3 | 0 |
| Serum glutamic oxaloacetic transaminase - Grade 4 | 0 |
| Serum glutamic pyruvic transaminase - Grade 1 | 7 |
| Serum glutamic pyruvic transaminase - Grade 2 | 0 |
| Serum glutamic pyruvic transaminase - Grade 3 | 0 |
| Serum glutamic pyruvic transaminase - Grade 4 | 0 |
| Dizziness/lightheadedness - Grade 1 | 1 |
| Dizziness/lightheadedness - Grade 2 | 0 |
| Dizziness/lightheadedness - Grade 3 | 0 |
| Dizziness/lightheadedness - Grade 4 | 0 |
| Headache - Grade 1 | 0 |
| Headache - Grade 2 | 1 |
| Headache - Grade 3 | 0 |
| Headache - Grade 4 | 0 |
| Creatinine - Grade 1 | 7 |
| Creatinine - Grade 2 | 1 |
| Creatinine - Grade 3 | 0 |
| Creatinine - Grade 4 | 0 |
| Renal failure - Grade 1 | 0 |
| Renal failure - Grade 2 | 0 |
| Renal failure - Grade 3 | 1 |
| Renal failure - Grade 4 | 0 |
| Renal/genitourinary - Other - Grade 1 | 6 |
| Renal/genitourinary - Other - Grade 2 | 2 |
| Renal/genitourinary - Other - Grade 3 | 1 |
| Renal/genitourinary - Other - Grade 4 | 0 |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Gemcitabine + Cisplatin | — | — | — |
| Event | Gemcitabine + Cisplatin |
|---|---|
| LeukopeniaBlood and lymphatic system disorders | 1/50 |
| NeutropeniaBlood and lymphatic system disorders | 1/50 |
| DeafnessEar and labyrinth disorders | 1/50 |
| Renal failure acuteRenal and urinary disorders | 1/50 |
| Event | Gemcitabine + Cisplatin |
|---|---|
| NauseaGastrointestinal disorders | 32/50 |
| VomitingGastrointestinal disorders | 25/50 |
| AstheniaGeneral disorders | 17/50 |
| Blood alkaline phosphatase increasedInvestigations | 15/50 |
| Aspartate aminotransferase increasedInvestigations | 14/50 |
| Weight decreasedInvestigations | 11/50 |
| Blood creatinine increasedInvestigations | 10/50 |
| Alanine aminotransferase increasedInvestigations | 9/50 |
| Creatinine renal clearance decreasedInvestigations | 9/50 |
| Weight increasedInvestigations | 9/50 |
| Age Continuous(years) | Gemcitabine + Cisplatin |
|---|---|
| Mean | 54.9 ± 10.7 |
| Sex: Female, Male(Participants) | Gemcitabine + Cisplatin |
|---|---|
| Female | 50 |
| Male | 0 |
| Region of Enrollment(participants) | Gemcitabine + Cisplatin |
|---|---|
| Russian Federation | 50 |
| Disease Stage(participants) | Gemcitabine + Cisplatin |
|---|---|
| Stage I - Tumor Limited to Ovaries | 0 |
| Stage II - Pelvic Extension and/or Implants | 0 |
| Stage IIIa - Microscopic Peritoneal Metastasis | 1 |
| Stage IIIb - Macroscopic Peritoneal Metastasis | 3 |
| Stage IIIc - Peritoneal Metastasis More Than 2 cm | 21 |
| Stage IV - Distant Metastases | 25 |
| Eastern Cooperative Oncology Group Performance Status Score(participants) | Gemcitabine + Cisplatin |
|---|---|
| 0 - Fully Active | 28 |
| 1 - Ambulatory, Restricted Strenuous Activity | 20 |
| 2 - Ambulatory, No Work Activities | 2 |
| 3 - Partially Confined to Bed, Limited Self Care | 0 |
| 4 - Completely Disabled | 0 |
| Postoperational Pathomorphological Diagnosis(participants) | Gemcitabine + Cisplatin |
|---|---|
| Serous Cystadenocarcinoma | 37 |
| Mucinosa Cystadenocarcinoma | 3 |
| Endometrioid Carcinoma | 4 |
| Other | 6 |
| Race/Ethnicity(participants) | Gemcitabine + Cisplatin |
|---|---|
| Caucasian | 49 |
| Other | 1 |
| State of Patient Relative to Menopause(participants) | Gemcitabine + Cisplatin |
|---|---|
| Fertile Period | 4 |
| Post-Menopause | 46 |
1 further baseline measures are reported on the registry.
This study is completed, as verified in Feb 2009. You cannot join it, but the record below documents what was studied.
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