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Gemcitabine Plus Cisplatin in Treating Patients With Ovarian Epithelial Cancer or Primary Peritoneal Cancer That Is Recurrent or Has Not Responded to Platinum-based Chemotherapy

This study has been completed.
National Cancer Institute (NCI)
Information provided by:
Gynecologic Oncology Group Identifier:
First received: July 5, 2000
Last updated: May 24, 2013
Last verified: March 2003

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of gemcitabine plus cisplatin in treating patients who have primary ovarian epithelial cancer or primary peritoneal cancer that is recurrent or has not responded to platinum-based chemotherapy.

Condition Intervention Phase
Ovarian Cancer Primary Peritoneal Cavity Cancer Drug: cisplatin Drug: gemcitabine hydrochloride Phase 2

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: Evaluation of Gemcitabine and Cisplatin in Recurrent, Platinum Resistant and Refractory Ovarian Cancer

Resource links provided by NLM:

Further study details as provided by Gynecologic Oncology Group:

Study Start Date: January 2001
Primary Completion Date: January 2007 (Final data collection date for primary outcome measure)
Detailed Description:


  • Determine the anti-tumor activity of gemcitabine and cisplatin in patients with recurrent or refractory platinum-resistant ovarian epithelial cancer or primary peritoneal carcinoma who have failed on higher priority treatment protocols.
  • Determine the nature and degree of toxicity of this regimen in this patient population.
  • Correlate ex vivo drug sensitivity and resistance with clinical response to this regimen in these patients.
  • Correlate molecular markers of drug responsiveness and cellular apoptosis with ex vivo measures of drug resistance in these patients.

OUTLINE: This is a multicenter study.

Patients receive cisplatin IV over 1 hour followed by gemcitabine IV over 1 hour on days 1 and 8. Courses repeat every 4 weeks in the absence of unacceptable toxicity or disease progression.

Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 19-51 patients will be accrued for this study within 5-14 months.


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No


  • Histologically confirmed primary ovarian epithelial cancer or primary peritoneal carcinoma

    • Recurrent or persistent disease
  • Bidimensionally measurable disease by physical examination or medical imaging techniques

    • Sonography is acceptable if lesions are clearly defined on initial examination and bidimensionally measurable
    • Ascites and pleural effusions are not considered measurable disease
  • Must not be eligible for a higher priority Gynecologic Oncology Group protocol
  • Must have received one, and only one, prior platinum-based chemotherapy regimen containing carboplatin, cisplatin, or another organoplatinum compound for management of primary disease

    • Initial treatment may include high-dose therapy, consolidation, or extended therapy administered after surgical or nonsurgical assessment
    • If no prior paclitaxel, a second regimen containing paclitaxel allowed
  • Platinum-resistant or refractory (i.e., treatment-free interval after platinum-based therapy of less than 6 months or progressed during platinum-based therapy)



  • Not specified

Performance status:

  • GOG 0-2

Life expectancy:

  • Not specified


  • Absolute neutrophil count at least 1,500/mm^3
  • Platelet count at least 100,000/mm^3


  • Bilirubin no greater than 1.5 times upper limit of normal (ULN)
  • SGOT no greater than 2.5 times ULN
  • Alkaline phosphatase no greater than 2.5 times ULN


  • Creatinine no greater than 1.5 times ULN


  • Not pregnant
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No active infection requiring antibiotics
  • No other malignancy within the past 5 years except nonmelanoma skin cancer
  • Sensory and motor neuropathy no greater than grade 1


Biologic therapy:

  • At least 3 weeks since prior biologic or immunologic therapy for ovarian or peritoneal cancer


  • See Disease Characteristics
  • No other prior cytotoxic chemotherapy for recurrent or persistent disease, including retreatment with initial chemotherapy regimens
  • No prior gemcitabine
  • At least 3 weeks since prior chemotherapy for ovarian or peritoneal cancer and recovered

Endocrine therapy:

  • At least 1 week since prior hormonal therapy for ovarian or peritoneal cancer
  • Concurrent continuation of hormonal replacement therapy allowed


  • At least 3 weeks since prior radiotherapy for ovarian or peritoneal cancer and recovered
  • No prior radiotherapy to only site of measurable disease
  • No prior radiotherapy to more than 25% of bone marrow


  • See Disease Characteristics
  • At least 3 weeks since prior surgery for ovarian or peritoneal cancer and recovered


  • At least 3 weeks since other prior therapy for ovarian or peritoneal cancer
  • No prior cancer treatment that would preclude study
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00006028

  Show 31 Study Locations
Sponsors and Collaborators
Gynecologic Oncology Group
National Cancer Institute (NCI)
Study Chair: Cheryl A. Brewer, MD University of Illinois College of Medicine at Peoria
  More Information

Publications: Identifier: NCT00006028     History of Changes
Other Study ID Numbers: CDR0000068041
Study First Received: July 5, 2000
Last Updated: May 24, 2013

Keywords provided by Gynecologic Oncology Group:
recurrent ovarian epithelial cancer
primary peritoneal cavity cancer

Additional relevant MeSH terms:
Ovarian Neoplasms
Peritoneal Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Abdominal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Peritoneal Diseases
Antineoplastic Agents
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs processed this record on September 21, 2017