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Phase II Clinical Trial of Docetaxel in Combination With Gemcitabine in Platinum-Resistant Ovarian Cancer and Primary Peritoneal Carcinoma


Phase 2
18 Years
N/A
Not Enrolling
Female
Ovarian Carcinoma, Peritoneal Neoplasms

Thank you

Trial Information

Phase II Clinical Trial of Docetaxel in Combination With Gemcitabine in Platinum-Resistant Ovarian Cancer and Primary Peritoneal Carcinoma


Primary Objective:

1. To determine the response rate, time to progression and survival (secondary) of the
combination of docetaxel and gemcitabine administered on a weekly basis to patients with
platinum-resistant ovarian cancer

Secondary Objective:

1. To determine the toxicity of this combination regimen in patients with
platinum-resistant ovarian cancer

2. To evaluate the toxicity and safety profile of a short course (one dose) of
premedication with steroids to patients receiving weekly gemcitabine and docetaxel

OUTLINE: Patients receive gemcitabine IV over 30 minutes on days 1 and 8, and docetaxel IV
over 60 minutes on day 8. Treatment repeats every 21 days until PD, unacceptable toxicity,
or patient's withdrawal.


Inclusion Criteria:



- Histologically proven diagnosis of epithelial ovarian ca

- Must have platinum-resistant disease. (Defined as progression during the most recent
platinum-based chemotx or relapse < 6 months after the most recent platinum-based
chemotx regimen.)

- Measurable or evaluable disease. (Patients whose dz is manifested only as an elevated
CA-125 [greater than or equal to 100] are eligible. If an elevated CA-125 is the only
manifestation of dz, it must be confirmed on 2 separate times, at least 2 weeks
apart. Patients with positive cytology only are not eligible.)

- Greater than or equal to 18 years of age

- GOG performance status less than or equal to 2

- AGC/ANC greater than or equal to 1.5; platelets greater than or equal to 100,000;
hemoglobin (Hgb) greater than or equal to 8.0.

- Creatinine less than or equal to 2.0

- Total bilirubin less than or equal to upper limit of normal (uln)

- SGOT and/or SGPT less than or equal to 2.5 x uln if alkaline phosphatase less than or
equal to uln, or alkaline phosphatase less than or equal to 4 x uln if transaminases
are less than or equal to uln. (If both SGOT/SGPT >1.5 x uln and alkaline phosphatase
> 2.5 x uln, patient is not eligible.)

- Fully recovered from acute toxicities secondary to prior treatment (tx)

- Signed informed consent

Exclusion Criteria:

- Prior treatment with gemcitabine or docetaxel

- Underlying medical, psychiatric, or social conditions that would preclude patient
from receiving treatment

- Peripheral neuropathy greater than or equal to Grade 2

- No prior tx with cisplatin or carboplatin

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Tumor Response Type: CR, PR, SD or PD

Outcome Description:

Tumor response will be based on the RECIST v1.0 criteria. CR (complete response)= disappearance of all target lesions, PR (partial response)= greater or equal to 30% decrease in sum of longest diameter of target lesions, SD (stable disease)= <30% decrease or <20% increase, PD (progressive disease)= greater or equal to 20% increase in longest diameter of target lesions. For patients with an elevated CA-125 as the only evidence of disease, a PR was defined as a decrease of 50% or more lasting at least 8 weeks (Rustin et al. JCO 14:1545-51, 1996). Disease assessment performed every 2 cycles (1 cycle = 21 days). Responders included CR and PR.

Outcome Time Frame:

6 months after enrollment of last participant

Safety Issue:

No

Principal Investigator

Agustin Garcia, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Southern California

Authority:

United States: Institutional Review Board

Study ID:

5GYN-02-2

NCT ID:

NCT00183794

Start Date:

November 2002

Completion Date:

May 2010

Related Keywords:

  • Ovarian Carcinoma
  • Peritoneal Neoplasms
  • Primary Peritoneal
  • Neoplasms
  • Carcinoma
  • Ovarian Neoplasms
  • Neoplasms, Glandular and Epithelial
  • Peritoneal Neoplasms

Name

Location

Norris Comprehensive Cancer CenterLos Angeles, California  90033