Gemcitabine and Docetaxel in Treating Patients With Relapsed or Refractory Ovarian Epithelial or Peritoneal Cancer

NCT00227721 | Completed Phase 2 Results DMC

• 3 other identifiers: CDR0000445432P30CA022453WSU-C-2713
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 4

Brief 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.

Conditions

Ovarian Cancer; Peritoneal Cavity Cancer

Keywords

recurrent ovarian epithelial cancer; peritoneal cavity cancer

Outcome Measures

Primary Outcomes (1)

• Response Rate to the Combination of Gemcitabine and Docetaxel in Patients With Platinum Sensitive and Resistant Epithelial Ovarian or Peritoneal Cancer.

  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)

• Progression-free Survival

  Every two cycles until disease progression or death, assessed up to 5 years

Study Arms (1)

Docetaxel & Gemcitabine hydrochloride

EXPERIMENTAL

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

Drug: Docetaxel; Drug: Gemcitabine hydrochloride

Interventions

Docetaxel DRUG

40 mg/m2, 30 minute IV infusion, Days 1 and 8, Every 21 days

Also known as: Taxotere®

Docetaxel & Gemcitabine hydrochloride

Gemcitabine hydrochloride DRUG

800mg/m2, 30 minute IV infusion, Days 1 and 8, every 21 days

Also known as: Gemzar ®

Docetaxel & Gemcitabine hydrochloride

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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 cancer

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Robert Morris: lead
• National Cancer Institute (NCI): collaborator

Study Sites (4)

Oakwood Cancer Center at Oakwood Hospital and Medical Center

Dearborn, Michigan, 48123-2500, United States

Location

Barbara Ann Karmanos Cancer Institute

Detroit, Michigan, 48201-1379, United States

Location

Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center

Columbus, Ohio, 43210-1240, United States

Location

Northern Virginia Pelvic Surgery Assoc

Annandale, Virginia, 22003, United States

Location

Related Links

• Clinical trial summary from the National Cancer Institute's PDQ® database

MeSH Terms

Conditions

Ovarian Neoplasms; Carcinoma, Ovarian Epithelial

Interventions

Docetaxel; Gemcitabine

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring

Limitations and Caveats

Small sample size

Results Point of Contact

• Title: Robert Morris, M.D.
• Organization: Barbara Ann Karmanos Cancer Institute

rmorris@med.wayne.edu

313-576-9436

Study Officials

• Robert T. Morris, MD

  Barbara Ann Karmanos Cancer Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 26, 2005
• First Posted: September 28, 2005
• Study Start: February 1, 2004
• Primary Completion: June 1, 2011
• Study Completion: February 1, 2017
• Last Updated: December 2, 2020
• Results First Posted: February 9, 2015

Record last verified: 2020-11

Locations

US (4)